61 studies found

S1827 (MAVERICK) Testing Whether the Use of Brain Scans Alone Instead of Brain Scans Plus Preventive Brain Radiation Affects Lifespan in Patients With Small Cell Lung Cancer

PRIMARY OBJECTIVE: I. To evaluate whether overall survival (OS) with magnetic resonance imaging (MRI) surveillance alone is not inferior to MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC). SECONDARY OBJECTIVES: I. To compare cognitive failure free survival (CFFS) rate up to...

Ramucirumab Plus Pembrolizumab vs Usual Care for Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer Following Immunotherapy, Pragmatica-Lung Study

PRIMARY OBJECTIVE: I. To compare overall survival (OS) in participants previously treated with platinum-based chemotherapy and immunotherapy for stage IV or recurrent non-small cell lung cancer (NSCLC) randomized to pembrolizumab and ramucirumab versus standard of care. SECONDARY OBJECTIVE: I. To summarize reports of serious and unexpected high-grade (>= grade 3)...

Confronting Cancer as a Community

PRIMARY OBJECTIVE: I. To create a well-characterized cohort of Hispanic patients with colon cancer, with patient-level data, genomic, transcriptomic, clinical, and outcomes data. SECONDARY OBJECTIVES: I. To identify genomic/transcriptomic predictors of treatment outcomes (time to recurrence, time to progression, and overall survival). II. To identify associations between somatic tumor deoxyribonucleic...

Stockholm3 Validation Study in a Multi-Ethnic Cohort

Study Design and Procedures: The research coordinator will explain the information contained within the consent. Additionally, patient's blood will be drawn prior to their biopsy. Prior to the biopsy, blood will be collected in x2 ethylenediaminetetraacetic acid (EDTA) 4 ml tubes after obtaining consent from the subjects. One tube will...

Core Biopsies for Establishing a Breast Tumor Tissue Repository

PRIMARY OBJECTIVES: I. To develop a baseline and serial breast cancer core biopsy repository within the University of Southern California (USC)/Norris Comprehensive Cancer Center Women's Cancer Program. II. To develop and maintain a secure clinical database of relevant demographic, clinical, pathologic and longitudinal outcome characteristics of the samples to be...

7 Tesla MRI Neuroimaging in Testicular Cancer Patients With Hypogonadism and on Androgen Replacement Therapy

PRIMARY OBJECTIVE: I. To assess longitudinal structural changes in brain architecture using MRI in hypogonadal men with testis cancer being treated with androgen replacement therapy. OUTLINE: This is an observational study. Patients undergo 7T MRI over 1-2 hours at baseline and at 12 months after baseline. Patients also undergo a...

Longitudinal Advanced Prostate Cancer Cohort (LAPCC)

PRIMARY OBJECTIVE: I. To create an annotated biorepository with prospectively collected blood and urine samples from men with advanced prostate cancer. OUTLINE: This is an observational study. Patients undergo blood and urine sample collection, complete surveys, and have their medical records reviewed on study.

Breast Cancer Survivorship Biorepository

PRIMARY OBJECTIVE: I. To create an annotated biorepository with prospectively collected blood samples from breast cancer survivors. SECONDARY OBJECTIVES: I. To collect comprehensive data on social determinants of health (e.g., race/ethnicity, acculturation, socioeconomic status, and access to care), environmental exposures (based on zip codes/geocoding), lifestyle (e.g., diet, tobacco use), clinicopathologic...

MAGESTIC Trial: MiRNA in Detecting Active Germ Cell Tumors in Early Suspected and MetastaTIC Disease Trial

PRIMARY OBJECTIVE: I. To measure the accuracy of the blood-based biomarker miRNA-371 to predict pre-operatively the presence of active germ cell malignancy. OUTLINE: This is an observational study. Patients undergo blood sample collection during screening and throughout the study. Patients whose screening blood samples show elevated miRNA-371 proceed to standard...

Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer

PRIMARY OBJECTIVES: I. To compare the proportions of participants in the tomosynthesis mammography (TM) and digital mammography (DM) study arms experiencing the occurrence of an ?advanced? breast cancer at any time during a period of 4.5 years from randomization, including the period of active screening and a period of clinical...

Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer

PRIMARY OBJECTIVE: I. To compare, in a non-inferiority fashion, the progression-free survival (PFS) in patients with metastatic refractory gastric/gastroesophageal junction (GEJ) adenocarcinoma receiving the combination of ramucirumab with trifluridine and tipiracil hydrochloride (TAS-102) versus (vs.) paclitaxel and ramucirumab. SECONDARY OBJECTIVES: I. To assess overall survival (OS) in this patient population...

A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer

PRIMARY OBJECTIVE: I. To compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among individuals with deleterious BRCA1 germline mutations. SECONDARY OBJECTIVES: I. To prospectively assess estrogen deprivation symptoms in pre-menopausal BLS patients as measured by the Functional...

AU409 for the Treatment of Advanced Primary Liver Cancers or Solid Tumor With Liver Metastatic Disease

PRIMARY OBJECTIVES: I. To determine maximum tolerated dose (MTD) of RNA transcription modulator AU-409 (AU409) and the recommended phase II dose (RP2D). II. To characterize the safety and tolerability of AU409 by assessing toxicities per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 criteria. SECONDARY OBJECTIVES: I. To...

Curcumin to Improve Inflammation and Symptoms in Patients With Clonal Cytopenia of Undetermined Significance, Low Risk Myelodysplastic Syndrome, and Myeloproliferative Neoplasms

PRIMARY OBJECTIVES: I. To compare the change in inflammatory cytokine levels in study patients treated with curcumin versus placebo over a 12-month follow-up period. II. To compare the change in symptomatology in study patients treated with curcumin versus placebo over a 12-month follow-up period. SECONDARY OBJECTIVES: I. To investigate the...

Photohandler

A Phase II trial of sEphB4-HSA in combination with Anti PD1 Antibody Pembrolizumab (MK-3475) for metastatic urothelial cancer refractory to platinum

Patients with the most common type of bladder cancer are initially treated with chemotherapy with regimens that include a platinum agent such as cisplatin or carboplatin. Once the cancer develops resistance the treatment is changed to an anti PD1/PDL1 immunotherapy with drugs such as pembrolizumab or nivolumab. This study proposes...

Vascularized Composite Bladder Allograft Transplantation

PRIMARY OBJECTIVE: I. To perform a feasibility study of vascularized composite bladder allograft (VCBA) transplantation and demonstrate successful transplantation of a vascularized composite deceased-donor bladder allograft. SECONDARY OBJECTIVES: I. To describe the adverse events associated with VCBA transplantation. II. To describe the immunosuppression regimen for patients undergoing VCBA transplantation. III....

S1501 Carvedilol in Preventing Cardiac Toxicity in Patients With Metastatic HER-2-Positive Breast Cancer

PRIMARY OBJECTIVES: I. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction in patients with metastatic breast cancer receiving trastuzumab?based HER-2 targeted therapy. SECONDARY OBJECTIVES: I. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention...

Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation

PRIMARY OBJECTIVE: I. To evaluate and compare the clinical complete response (cCR) rates in patients with locally advanced rectal cancer treated with neoadjuvant long-course neoadjuvant radiotherapy (LCRT) followed by neoadjuvant modified fluorouracil, irinotecan, leucovorin, and oxaliplatin (mFOLFIRINOX) versus neoadjuvant LCRT followed by neoadjuvant modified leucovorin , fluorouracil, and oxaliplatin (mFOLFOX6)....

Testing Nivolumab and Ipilimumab Immunotherapy With or Without the Targeted Drug Cabozantinib in Recurrent, Metastatic, or Incurable Nasopharyngeal Cancer

PRIMARY OBJECTIVE: I. To determine if the progression-free survival (PFS) of the triplet combination (cabozantinib S-malate, nivolumab, and ipilimumab [CaboNivoIpi]) is more favorable than the doublet (nivolumab and ipilimumab [NivoIpi]). SECONDARY OBJECTIVES: I. To compare safety and tolerability between the two arms (Common Terminology Criteria for Adverse Events [CTCAE] version...

Testing the Safety and Efficacy of the Addition of A New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Etoposide and Cisplatin) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma

PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of the addition of BET bromodomain inhibitor ZEN-3694 (ZEN003694) to etoposide and cisplatin (EP) in participants with NUT Carcinoma (NC). (Phase 1) II. Evaluate the overall objective response rate (ORR) of the addition of ZEN003694...

Testing Atezolizumab With or Without Selinexor in Patients >= 18 Years Old With Alveolar Soft Part Sarcoma, the Axiom Study

PRIMARY OBJECTIVE: I. Determine the overall response rate (by Response Evaluation Criteria in Solid Tumors [RECIST] version [v]1.1) for selinexor in combination with atezolizumab in immune checkpoint inhibitor (ICI)-naive patients with alveolar soft part sarcoma (ASPS). SECONDARY OBJECTIVE: I. Assess the number of activated CD8+ T cells infiltrating the tumor...

Testing the Anti-Cancer Drug Darolutamide in Patients With Testosterone-driven Salivary Gland Cancers

PRIMARY OBJECTIVE: I. To evaluate the best overall response rate (BOR) of recurrent/metastatic androgen receptor positive (AR+) salivary gland cancer (SGC) patients within one year of darolutamide and androgen deprivation therapy (ADT). SECONDARY OBJECTIVES: I. To evaluate progression-free survival (PFS). II. To evaluate overall survival (OS). III. To evaluate toxicity...

Testing the Combination of Two Anticancer Drugs M1774 (Tuvusertib) and Avelumab to Evaluate Their Safety and Effectiveness in Treating Merkel Cell Skin Cancer, MATRiX Trial

PRIMARY OBJECTIVE: I. To compare the potential efficacy, using progression free survival (PFS), of ATR inhibition alone to ATR inhibition plus anti-PD-(L)1 therapy through a randomized clinical trial for patients with advanced Merkel cell carcinoma (MCC) who have progressed on anti-PD(L)1 therapy. SECONDARY OBJECTIVES: I. To compare the clinical activity...

Testing a New Chemotherapy Drug, KRT-232 (AMG-232) in Combination With Decitabine and Venetoclax in Patients With Acute Myeloid Leukemia

PRIMARY OBJECTIVE: I. To evaluate the toxicities of navtemadlin (KRT-232 [AMG-232]) in combination with decitabine (20 mg/m^2 for 10 days), and venetoclax, and to determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of KRT-232 (AMG-232) in combination with a standard dose of decitabine and venetoclax. SECONDARY OBJECTIVES: I....

Venetoclax in Combination With ASTX727 for the Treatment of Chronic Myelomonocytic Leukemia and Other Myelodysplastic Syndrome/Myeloproliferative Neoplasm

PRIMARY OBJECTIVE: I. To evaluate the complete remission rates of ASTX727 and ASTX727 plus venetoclax in subjects with chronic myelomonocytic leukemia (CMML) and non-CMML myelodysplastic syndrome (MDS)/myeloproliferative neoplasm (MPN) with excess (>= 5%) blasts. SECONDARY OBJECTIVES: I. To evaluate the overall response rate (complete response [CR] + partial response [PR]...