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Study Title Principal Investigator
2L-14-1 Genomics of Young Lung Cancer Study
PRIMARY OBJECTIVES: I. To perform comprehensive genomic analysis of young lung cancer patients' samples to facilitate delivery of targeted therapies and clinical trial enrollment. II. To characterize the impact of young age at lung cancer diagnosis on the genomic landscape of primary lung cancer. III. To establish a prospective registry of young lung cancer patients for both tumor and germline next generation sequencing. OUTLINE: Tissue and blood samples are analyzed via next generation sequencing and whole exome sequencing. After completion of study, patients are followed up every 3 months for up to 3 years.
Recruiting | Lung Cancer | Multisite
Barbara Gitlitz
Assessment of Novel Biomarkers in Patients With Metastatic Castration Resistant Prostate Cancer
PRIMARY OBJECTIVES: I. Perform molecular analysis of plasma samples from 25 patients with metastatic prostate cancer collected before and during treatment of the disease with abiraterone acetate (Zytiga) or enzalutamide (Xtandi). II. Perform molecular characterization of circulating tumor cells (CTCs) and plasma collected from 75 patients with progressing advanced metastatic prostate cancer. OUTLINE: Patients are assigned to 1 of 2 groups based on the timing of specimen collection. GROUP I: Previously collected plasma samples are analyzed for ctDNA via polymerase chain reaction (PCR) and next generation sequencing (NSG). GROUP II: Patients undergo collection of blood samples before and following systemic therapy for analysis of CTC enumeration, ribonucleic acid (RNA) expression, and ctDNA via PCR and NSG.
Recruiting | Prostate Cancer | Not Multisite
Mitchell Gross
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A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients With Resected Stage III Colon Cancer
OBJECTIVES: Primary - To compare disease-free survival of patients with resected stage III colon cancer treated with adjuvant FOLFOX chemotherapy comprising oxaliplatin, fluorouracil, and leucovorin calcium with versus without celecoxib. Secondary - To contribute to an international prospective pooled analysis comparing disease-free survival of patients treated with these regimens. - To compare overall survival at 3 years of patients treated with these regimens. - To contribute to an international prospective pooled analysis comparing disease-free survival of patients treated with 6 versus 12 courses of FOLFOX chemotherapy. - To assess toxicities of celecoxib as maintenance adjuvant therapy in these patients. - To assess differences in cardiovascular-specific events in patients treated with versus without celecoxib. - To evaluate differences in toxicities, particularly cumulative peripheral neuropathy, in patients treated with 6 versus 12 courses of FOLFOX chemotherapy. OUTLINE: This is a multicenter study. Patients are stratified according to number of positive lymph nodes* (1-3 vs 4 or more) and concurrent regular low-dose of aspirin (yes vs no). Patients are randomized to 1 of 4 treatment arms. NOTE: *Patients with N1c-only disease (i.e., no positive nodes but N1c disease by AJCC 7) should be stratified to 1-3 nodes. - Arm I: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours (FOLFOX) on day 1. Patients also receive oral celecoxib once daily on days 1-14 beginning on day 1 of course 2 of FOLFOX. Courses repeat every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive FOLFOX as in arm I and oral placebo once daily on days 1-14 beginning on day 1 of course 2. Courses repeat every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity. - Arm III: Patients receive FOLFOX and celecoxib as in arm I. Courses repeat every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. - Arm IV: Patients receive FOLFOX and placebo as in arm II. Courses repeat every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. In all arms, treatment with celecoxib or placebo continues for 3 years in the absence of disease progression or unacceptable toxicity. Blood and tissue samples maybe collected for biomarker analysis and pharmacogenomic studies. After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for years 2-3, and then annually for 3 years.
Recruiting | Colon / Rectal Cancer | Multisite
Jeffrey Meyerhardt
A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients With Metastatic Breast Cancer
OBJECTIVES: Primary - To evaluate whether early local therapy comprising surgery of intact primary disease compared to local palliative therapy only in patients with stage IV breast cancer, whose disease does not progress during initial optimal systemic therapy, will result in prolonged survival. Secondary - To compare the time to uncontrolled chest wall disease between patients treated with these regimens. - To determine whether there is a difference in health-related quality-of-life (HRQOL) between patients treated with these regimens. - To determine whether the absolute value of circulating tumor cells (CTC) burden at 6 months following randomization (time +6) will be lower in the palliative therapy arm than in early local therapy arm, and whether this value is inversely related to survival (lower CTC, longer survival). - To collect tumor and blood specimens for future exploration of the biological interactions between the primary tumor and metastatic lesions and the effect of primary tumor resection. OUTLINE: This is a multicenter study. Patients are stratified according to hormone receptor and treatment plan (ER+ or PR+, HER2-, endocrine therapy alone vs ER+ or PR+, and HER2-, chemotherapy and/or endocrine therapy vs ER- or PR-, and HER2- vs HER2+), and number of involved organ systems with distant disease (regional nodes in the axillary, supraclavicular, and internal mammary locations are not considered distant sites) (1 vs > 1). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both. - Arm II: Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Surgery is to occur no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician. Patients may undergo blood and tumor tissue sample collection for circulating tumor cells (CTC) burden and future studies. Patients complete the Functional Assessment of Cancer Therapy - Breast Trial Outcome Index (FACT- TOI) and FACT - General (22) and the Breast Cancer Subscale (FACT-B) quality-of-life questionnaires at baseline and periodically during study. After completion of study therapy, patients are followed up periodically for 5 years.
Recruiting | Breast Cancer | Multisite
Seema Khan
Combined Exercise Program for Early Breast Cancer Survivors
PRIMARY OBJECTIVES: I. To determine whether a 16-week exercise intervention will improve components of metastasis (MetS) in breast cancer survivors soon after completion of cancer-related treatments by measuring changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and hemoglobin A1c (HbA1c). II. To determine whether a 16-week exercise intervention will improve physical fitness in breast cancer survivors soon after completion of cancer-related treatments by measuring cardiorespiratory fitness and muscle strength. III. To assesses the feasibility of a supervised exercise intervention in early breast cancer survivors. IV. To determine whether a 16-week exercise intervention will result in a reduction in adipose tissue inflammation in obese breast cancer survivors soon after completion of cancer-related treatments by measuring ATM phenotype and ATM cytokine expression. V. To determine whether breast cancer survivors can maintain positive benefits of an exercise intervention following a 12-week follow-up period by measuring changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and HbA1c, cardiorespiratory fitness and muscle strength. OUTLINE: Patients are randomized to 1 of 2 arms. Arm I (Control): Patients refrain from increasing physical activity levels for 16 weeks. Arm II (Exercise): Patients participate in supervised exercise sessions over 60 minutes thrice weekly and are encouraged to participate in a home-based exercise session over 30-45 minutes once weekly for 16 weeks.
Recruiting | Breast Cancer | Not Multisite
Christina Dieli-Conwright
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SWOG-S1011: A Phase III Surgical Trial to Evaluate the Benefit of a StandardVersus an Extended Pelvic Lymphadenectomy Performed At Time of RadicalCystectomy For Muscle Invasive Urothelial Cancer.
OBJECTIVES: Primary - To compare disease-free survival (DFS) of patients with muscle-invasive urothelial carcinoma of the bladder undergoing radical cystectomy with extended pelvic lymph node dissection (PLND) or standard pelvic lymphadenectomy. Secondary - To compare overall survival (OS) of patients randomized to extended PLND versus those randomized to standard pelvic lymphadenectomy. - To evaluate operative time; whether or not nerve sparing was performed, intraoperative, peri-operative and 90-day morbidity and mortality; length of hospital stay; histology (pure urothelial versus mixed); lymph node counts and lymph node density; adjuvant chemotherapy received; and local and retroperitoneal soft tissue recurrence in patients randomized to extended PLND versus those randomized to standard pelvic lymphadenectomy. - To collect peripheral blood and two paraffin-embedded blocks of the primary tumor for translational medicine studies, including circulating tumor cells (CTCs) and markers of epithelial and mesenchymal transition, and correlate these findings with pathologic T stage and node metastasis as well as DFS and OS. OUTLINE: This is a multicenter study. Patients are stratified according to prior neoadjuvant therapy (yes vs no), clinical stage (T2 vs T3 vs T4a), and Zubrod performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo radical cystectomy and standard pelvic lymphadenectomy. - Arm II: Patients undergo radical cystectomy and extended pelvic lymphadenectomy. Blood and tumor specimens may be collected periodically for translational studies. After completion of study therapy, patients are followed up periodically for 6 years.
Recruiting | Bladder Cancer | Multisite
Sia Daneshmand
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5C-11-2 Phase II Clinical Trial of Eribulin in Advanced or Recurrent Cervical Cancer
Cervical cancer is the second most common cancer in women worldwide; and, in developing countries, it is the leading cause of death by cancer. Treatment for advanced disease after the use of platinum based therapy yields low response and survival rates, therefore there is a huge need for the identification of active agents.. Eribulin is a targeted agent that inhibits cell growth in multiple types of cancers. Previous studies have shown that it improves response and survival rates. This study is a phase II, single arm, two-stage study using eribulin in patients with advanced cervical cancer. The primary objective of this study is to evaluate the effectiveness of eribulin in these patients.Patients with laboratory confirmed invasive cervical cancer who have had up to 1 previous chemotherapy regimen for advanced disease will be considered for this study. Once patients have agreed to participate, they will be screened for eligibility. Once they are deemed eligible, they will receive eribulin through a vein in the arm on Days 1 and 8 of a 21-day treatment cycle. They will have a study visits during each cycle that will include the following tests and procedures: blood tests, physical exams, vital signs, ECG to check their heart, evaluation of their ability to carry out everyday activities, and an evaluation of side effects. They will also have x-rays or CT/MRI scans to determine whether their tumor is growing. Tumor tissue from a previous biopsy or surgery and blood samples will be collected for research testing. Subjects will continue taking the study drug until their tumor grows or they have unacceptable side effects.Fifteeen patients will be treated and evaluated in the first stage; if 1 or more of the 15 patients achieves a progression free survival of 6 months, an additional 15 patients will be accrued into the second stage.The primary efficacy endpoint will be 6-month progression-free survival. The secondary efficacy endpoint will be best overall response. The occurrence of toxic death (TD) at any time will be a primary endpoint for safety monitoring. The study will be terminated if fewer than 1 out of 15 patients are progression-free at 6 months.
Recruiting | Gynecologic Cancers | Not Multisite
Lynda Roman
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0C-12-1-A Phase 1 Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics and Safety of Crizotinib in Advanced Cancer Patients [A8081012]
This is a research study for advanced cancer with varying degree of liver function (normal, mild impairment, moderate impairment or severe impairment). The main purposes of this research study are to see whether a newly approved drug, crizotinib (Xalkori), can be used in patients with liver function that is not normal and to see whether crizotinib can prevent or slow down your cancer from growing, and to assess any side effects that you may have. Some other purposes of this study are to measure how much crizotinib is in your blood, and to provide dosing recommendations for patients with impaired liver function. Crizotinib is approved in the United States (US) and is available by prescription for non-small cell lung cancer (NSCLC) patients with Anaplastic Lymphoma Kinase (ALK) mutation. However, the use of crizotinib in this study is experimental. Crizotinib is not currently approved to treat other advanced cancer patients with unclear ALK status and/or with liver function that is not normal. . The participants of this study will be in this study until their disease progresses (gets worse), they experience unacceptable side effects or they withdraw consent. There will be about 50 advanced cancer patients enrolled in this study. The study is being done at about 3-5 different research sites in US. About 45 participants will take part at USC. This is a multicenter, open-label, non-randomized, phase 1 study. The endpoints are how the drug behaves in the body when taken (pK), effectiveness and safety of the study drug. There will be 5 groups (Groups A1, A2, B, C and D) involved in this study. Groups A1 and A2 have normal liver functions. Group A1 will match Group B(mild) and Group A2 will match Group C(moderate).The study drug is given by mouth and should be taken at approximately the same time each day on a continuous daily dosing.One-way analysis of variance (ANOVA) will be used for statistical analysis. Individual concentration of the study drug in the blood will be listed and summarized. The safety analysis population will include all enrolled patients who receive at least one does of crizotinib. The safety analysis population will be the primary population for evaluating patient characteristics, treatment administration and safety. Safety data will be reviewed on an ongoing basis during the study.
Recruiting | Any Cancer Condition or Solid Tumor | Multisite
Anthony El-Khoueiry
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SWOG-S1211: A Randomized Phase I/II Study of Optimal Induction Therapy of Bortezomib, Dexamethasone and Lenalidomide with or without Elotuzumab (NSC-764479) for Newly Diagnosed High Risk Multiple Myeloma (HRMM)
PRIMARY OBJECTIVES: I. To determine the appropriate Phase II dose of elotuzumab to use in combination with lenalidomide, bortezomib, and dexamethasone for patients with multiple myeloma. (Phase I) II. To assess whether incorporation of the novel agent elotuzumab into the treatment algorithm of high-risk multiple myeloma (HRMM) will improve progression-free survival (PFS). (Phase II) III. To estimate the frequency and severity of toxicities of this treatment strategy in this patient population. (Phase II) OUTLINE: This is a phase I, dose-escalation study of elotuzumab, followed by a phase II, randomized study. PHASE I: INDUCTION: Patients receive bortezomib subcutaneously (SC) or intravenously (IV) on days 1, 4, 8, and 11; lenalidomide orally (PO) once daily (QD) on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12 (and on day 15 of courses 1 and 2 only). Patients also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; dexamethasone PO on days 1, 8, and 15; and elotuzumab IV on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. PHASE II: Patients are randomized to 1 of 2 treatment arms. ARM I: INDUCTION: Patients receive bortezomib SC or IV on days 1, 4, 8, and 11; lenalidomide PO QD on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity (patients who received a course of chemotherapy prior to registration will begin protocol treatment with course 2 and receive a total of 7 courses of protocol therapy). MAINTENANCE: Patients receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; and dexamethasone PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM II: INDUCTION: Patients receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Patients also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Patients also receive elotuzumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for up to 6 years.
Recruiting | Blood Cancer | Multisite
Sikander Ailawadhi
16M-14-1: Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients with Relapsed and/or Refractory Multiple Myeloma
Multiple myeloma is a type of blood cancer caused by the transformation and uncontrolled multiplication of plasma cells (a type pf blood cell). It is the second most common hematological malignancy and is invariably fatal. Myeloma cells expand in the bone marrow causing skeletal destruction, high calcium levels, kidney failure and anemia. The study population will consist of multiple myeloma patients requiring therapy who have relapsed and/or are refractory to their last therapy and have been treated with at least 1, but not more than 5 lines of multiple myeloma therapy. The study drug, oprozomib works by preventing the breakdown of certain proteins in cells, causing the cells to die. Studies with oprozomib have been able to demonstrate the treatment potential for blocking proteasomes (protein complexes) in multiple myeloma. These proteasomes main function is to degrade unneeded or damaged proteins. The primary objective of Phase 2 is to estimate the overall response rate. This study is an open-label, Phase 1b/2, multicenter study in which participants will receive oprozomib administered orally, once daily, in combination with dexamethasone as follows: Days 1, 2, 8, and 9 of a 14-day cycle; Treatment will be administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. USC will only participate in Phase 2. The Phase 2 portion of this study will be initiated at the sponsors discretion using the recommended dose determined from 1 or both dosing schedules. The total study duration is expected to be approximately 26 months.
Recruiting | Blood Cancer | Multisite
Kevin Kelly
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Phase 2 Trial of phenelzine in non-metastatic recurrent prostate cancer
Prostate cancer is the most common non-cutaneous cancer diagnosed in men in the United State with a projected annual incidence of ~29,000 deaths in 2013. For most patients, prostate cancer is adequately treated with primary therapy which may include radiation, surgery (radical prostatectomy, or active surveillance. However, in about one third of patients, cancer recurs following primary therapy usually manifested as an asymptomatic rise in plasma prostate specific antigen (PSA) level. Biochemical recurrence (BCR) defines patients with a confirmed elevation in PSA in the absence of clinically detectable metastatic disease. Given the slow disease course of BCR prostate cancer and the frequent occurrence of other life-altering co-morbidities in this patient population, BCR is a very common condition for which there are no clear standards in terms of the composition of timing of potential treatments. We hypothesize that phenelzine will exert an anti-cancer effect demonstrated by decreasing PSA values in biochemical recurrent prostate cancer patients. In this trial, a dose of 60 mg daily is set as the target dose level based on patient tolerance drawn from the experience in patients with depression. The primary objective in this study is to assess the proportion of patients with biochemically recurrent prostate cancer treated with phenelzine who achieve a PSA decline of >/= 50% from baseline. The secondary objectives of this study are to monitor for potential toxicities and/or beneficial effects of phenelzine in prostate cancer without depression, mania or other primary psychiatric diagnosis; to assess time to radiographic disease progression for patients with recurrent prostate cancer treated with phenelzine. The exploratory objective is to collect blood and other samples to study the relationship between MAO activity, biomarkers and prostate cancer. The study population for this study will be men with asymptomatic non-metastatic prostate cancer. A total of 46 patients will be enrolled. 23 with non-castrate circulating androgen levels (testosterone > 50 ng/dl); 23 with castrate levels of circulating androgens (testosterone <50 ng/dl). The dose of phenelzine will be 30mg orally twice a day. The starting dose will be 15 mg daily escalated to 30 mg twice a day over 15 days (Please see section 4.1). Laboratory assessments, including plasma PSA at baseline and following every 28 day cycle. Imaging assessment including CT scans of chest/abdomen/pelvis and bone scan at baseline and every 12 weeks or as clinically indicated.
Recruiting | Prostate Cancer | Multisite
Mitchell Gross
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PhI-78, Patient-Derived Models Tissue Procurement Protocol For The National Cancer Institute (NCI)
PRIMARY OBJECTIVES: I. To procure biologic tissues and materials to generate preclinical models of cancer. OUTLINE: Tumor tissue and blood samples are procured during procedures that are required for the patients? clinical management and will be stored via xenograft (transplant to another species) models or in vitro cell culture for future analysis.
Recruiting | | Multisite
Heinz-Josef Lenz
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A Phase II Randomized Study Comparing Two Doses of Carfilzomib (NSC-756640) With Dexamethasone for Multiple Myeloma Patients With Relapsed or Refractory Disease
PRIMARY OBJECTIVES: I. To evaluate and compare progression free survival (PFS) of two different doses of carfilzomib with dexamethasone in multiple myeloma (MM) patients with relapsed and/or refractory disease. SECONDARY OBJECTIVES: I. To evaluate and compare response rates (RR) for each arm. II. To evaluate response rates (RR) for patients that relapse on low dose carfilzomib and subsequently cross-over to high dose carfilzomib. III. To evaluate the safety of this combination for this patient population. IV. To evaluate overall survival (OS). TERTIARY OBJECTIVES: I. To explore the molecular variability in MM cells obtained from extramedullary bone marrow relapse sites. II. To explore the role of positron emission tomography (PET) scanning in assessing disease burden and as a tool to assess treatment response. III. To explore changes in left ventricular ejection fraction (LVEF) in patients with relapsed or refractory multiple myeloma treated with low dose carfilzomib or high dose carfilzomib plus dexamethasone. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive dexamethasone intravenously (IV) and low-dose carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16. Patients with progression cross-over to Arm II. ARM II: Patients receive dexamethasone IV and high-dose carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Note that for the first course of treatment on both arms carfilzomib is given at a reduced rate to assess toxicity. In both arms, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 3 years from initial registration.
Recruiting | Blood Cancer | Multisite
Sikander Ailawadhi
A Multicenter Trial of FDG-PET/CT Staging of Head and Neck Cancer and Its Impact on the N0 Neck Surgical Treatment in Head and Neck Cancer Patients
OBJECTIVES: Primary - Determine the negative predictive value of PET/CT imaging based upon pathologic sampling of the neck lymph nodes in patients with head and neck cancer planning to undergo N0 neck surgery. - Determine the potential of PET/CT imaging to change treatment. Secondary - Estimate the sensitivity and diagnostic yield of PET/CT imaging for detecting occult metastasis in the clinical N0 neck (both by neck and lymph node regions) or other local sites. - Determine the effect of other factors (e.g., tumor size, location, secondary primary tumors, or intensity of FDG uptake) that can lead to identification of subsets of patients that could potentially forego neck dissection or that can provide preliminary data for subsequent studies. - Compare the cost-effectiveness of using PET/CT imaging for staging head and neck cancer vs current good clinical practices. - Evaluate the incidence of occult distant body metastasis discovered by whole-body PET/CT imaging. - Correlate PET/CT imaging findings with CT/MRI findings and biomarker results. - Evaluate the quality of life of these patients, particularly of those patients whose management could have been altered by imaging results. - Evaluate PET/CT imaging and biomarker data for complementary contributions to metastatic disease prediction. - Compare baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct assessment of their prediction of recurrence, disease-free survival, and overall survival. - Determine the proportion of neck dissections that are extended (i.e., additional levels that clinicians intend to dissect beyond the initial surgery plan) based on local-reader PET/CT imaging findings shared with the surgeon before dissection. - Estimate the optimum cutoff value of standardized uptake values for diagnostic accuracy of PET/CT imaging. - Evaluate the impact of PET/CT imaging on the N0 neck across different tumor subsites (defined by anatomic location). OUTLINE: This is a multicenter study. Patients undergo fludeoxyglucose F 18-PET/CT imaging. Approximately 14 days later, patients undergo unilateral or bilateral neck dissection. Patients complete quality-of-life questionnaires at baseline and at 1, 12, and 24 months after surgery. Patients undergo blood and tissue sample collection periodically for biomarker analysis. Patients are followed up periodically for up to 2 years after surgery.
Recruiting | Head and Neck Cancers | Multisite
Val Lowe
Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer
PRIMARY OBJECTIVES: Screening component: I. To establish a National Clinical Trials Network (NCTN) mechanism for genomically screening large but homogeneous cancer populations and subsequently assigning and accruing simultaneously to a multi-sub-study "Master Protocol." II. To evaluate the screen success rate defined as the percentage of screened patients that register for a therapeutic sub-study. Sub-study-specific Objectives: Design #1: Phase II/III Design: III. To evaluate if there is sufficient evidence to continue to the Phase III component of the sub-study by comparing investigator-assessed progression-free survival (IA-PFS) between investigational therapy versus standard therapy (SoC) in patients with advanced stage refractory squamous cell carcinoma (SCCA) of the lung. (Phase II) IV. To determine if there is both a statistically and clinically-meaningful difference in IA-PFS among advanced stage refractory SCCA of the lung randomized to receive investigational therapy versus SoC. (Phase III) V. To compare overall survival (OS) in patients with advanced stage refractory SCCA of the lung randomized to investigational therapy versus SoC. (Phase III) Design #2: Phase II followed by Phase III (Sequential Phase II to Phase III): VI. To evaluate the objective response rate (confirmed and unconfirmed, complete and partial). (Phase II) VII. To determine if there is both a statistically and clinically-meaningful difference in IA-PFS among advanced stage refractory SCCA of the lung randomized to receive investigational therapy versus SoC. (Phase III) VIII. To compare overall survival (OS) in patients with advanced stage refractory SCCA of the lung randomized to investigational therapy versus SoC. (Phase III) SECONDARY OBJECTIVES: Sub-study-specific Objectives: Design #1: Phase II/III Design: I. To compare response rates (confirmed and unconfirmed, complete and partial responses) among patients randomized to receive investigational therapy versus SoC. (Phase II) II. To evaluate the frequency and severity of toxicities associated with investigational therapy versus SoC. (Phase II) III. To evaluate the duration of response (DoR) among patients who achieve a complete response (CR) or a partial response (PR) by Response Evaluation Criteria In Solid Tumors (1.1). (Phase II) III. To compare the response rates (confirmed and unconfirmed, complete and partial) among patients randomized to receive investigational therapy versus SoC. (Phase III) IV. To evaluate the frequency and severity of toxicities associated with investigational therapy versus SoC. (Phase III) Design #2: Phase II followed by Phase III (Sequential Phase II to Phase III): V. To evaluate PFS and OS with investigational therapy. (Phase II) VI. To evaluate the DoR among patients who achieve a CR or PR (confirmed and unconfirmed) by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. (Phase II) VII. To evaluate the frequency and severity of toxicities associated with investigational therapy. (Phase II) VIII. To compare the response rates (confirmed and unconfirmed, complete and partial) among patients randomized to receive investigational therapy versus SoC. (Phase III) IX. To evaluate the frequency and severity of toxicities associated with investigational therapy versus SoC. (Phase III) TERTIARY OBJECTIVES: I. To evaluate the treatment arm randomization acceptance rate (TARAR) within each treatment arm of each sub-study defined as the percentage of patients randomized to a treatment arm that receive any protocol treatment. (Design #1: Phase II/III Design) II. To identify additional predictive tumor/blood biomarkers that may modify response or define resistance to the targeted therapy (TT)/targeted therapy combination (TTC) beyond the chosen biomarker for biomarker-driven sub-studies. III. To evaluate potentially predictive biomarkers for non-match therapy (NMT) in the non-match studies. IV. To identify potential resistance biomarkers at disease progression. V. To establish a tissue/ blood repository from patients with refractory SCCA of the lung. OUTLINE: Patients are assigned to a biomarker-driven targeted therapy phase II study. If the objectives response rate observed is judged sufficient, patients proceed to a randomized phase III trial and are randomized to biomarker-driven targeted therapy or standard of care. S1400A: (Closed to accrual 12/2015) Patients with tumors that do not match one of the currently active drug-biomarker combinations or did not meet the eligibility requirements for that bio-marker driven sub-study are assigned to Arm I. Upon evidence of progression following discontinuation of 12 months of treatment, patients may restart treatment for up to 12 months with the same treatment guidelines followed during the initial 12-month treatment period (Arm III). ARM I: (Closed to accrual 12/2015) Patients receive anti-B7H1 monoclonal antibody MEDI4736 intravenously (IV) over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity. ARM II (CLOSED TO ACCRUAL 4/2015): Patients receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #2 4/22/15) ARM III: For patients assigned to Arm 1, MEDI4736: Upon evidence of progression following discontinuation of 12 months of treatment, patients may restart treatment with Arm 3, MEDI4736 for up to 12 months with the same treatment guidelines followed during the initial 12-month treatment period. Patients will only be able to restart treatment once; thus a maximum of two 12-month periods will be allowed. Patients receive anti-B7H1 monoclonal antibody MEDI4736 intravenously (IV) over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity. S1400B: Patients with tumors positive for phosphoinositide 3-kinase (PI3KCA) are assigned to Arm I. Patients currently on Arm 2, docetaxel will be given the option to re-register to Arm 3, GCD-0032 after disease progression on current treatment (Arm III). ARM I: Patients receive taselisib orally (PO) daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM II (CLOSED TO ACCRUAL 12/18/2015): Patients receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #3 12/18/2015) ARM III: Re-Registration Treatment with GDC-0032 (Taselisib) Upon progression patients in Arm 2 may be eligible for Re-Registration to receive GDC-0032. Patients receive taselisib orally (PO) daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. S1400C: Patients with tumors positive for cyclin dependent kinase 4 (CDK4), cyclin D1 (CCND1), cyclin D2 (CCND2), and cyclin D3 (CCND3) are assigned to Arm I. Patients currently on Arm 2, docetaxel will be given the option to re-register to Arm 3, palbociclib, after disease progression on current treatment (Arm III). ARM I: Patients receive palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM II (CLOSED TO ACCRUAL 12/18/2015): Patients receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #3 12/18/2015) ARM III: Re-Registration Treatment with Palbociclib. Upon progression patients in Arm 2 may be eligible for Re-Registration to receive palbociclib. Patients receive palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. S1400D: Patients with tumors positive for fibroblast growth factor receptor (FGFR) 1, FGFR2, and FGFR3 are assigned to Arm I. Patients currently on Arm 2, docetaxel will be given the option to re-register to Arm 3, AZD4547, after disease progression on current treatment (Arm III). ARM I: Patients receive FGFR inhibitor AZD4547 PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM II (CLOSED TO ACCRUAL 12/18/2015): Patients receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #3 12/18/2015) ARM III: Re-Registration Treatment with AZD4547. Upon progression patients in Arm 2 may be eligible for Re-Registration to receive AZD4547. Patients receive FGFR inhibitor AZD4547 PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. S1400E (CLOSED TO ACCRUAL 11/2014): Patients with tumors positive for met proto-oncogene (MET) are randomized to 1 of 2 treatment arms. (permanently closed to accrual on 11/25/14) ARM I: Patients receive rilotumumab IV on day 1 and erlotinib hydrochloride PO daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive erlotinib hydrochloride PO daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. S1400I: Patients with tumors that do not match one of the currently active drug-biomarker combinations or did not meet the eligibility requirements for that bio-marker driven sub-study are randomized to 1 of 2 treatment arms. ARM I: Patients receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 60 minutes on day 1 of every third course. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, all patients are followed up periodically for up to 3 years from date of screening registration.
Recruiting | Lung Cancer | Multisite
Jorge Nieva
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