Norris ORIEN Total Cancer Care Protocol: A Lifetime Partnership With Patients
PRIMARY OBJECTIVES:
I. To establish a longitudinal study of clinical and related data from patients with or at
risk for cancer.
II. To establish a large biospecimen repository that is linked to clinical and related data.
III. To follow patients through their lifetime though passive or active follow-up.
IV. To use clinical data, tissues, other biological samples and derived molecular data in the
Total Cancer Care Protocol (TCCP) repositories to match patients in this TCCP study to future
studies.
OUTLINE:
Patients undergo collection of blood during a regular care visit or not up to 4 times a year.
Extra tissue is collected after removal during standard of care surgery and patients may
undergo additional tumor sampling (needle passes) at the time of planned diagnostic biopsies.
During bone marrow biopsy, the doctor may reposition the needle up to 3 times, and bone
marrow for research will not be collected more than 4 times per year. Patients may undergo
additional collection of other biological samples such as saliva, sputum, urine, feces, hair,
and surface skin swabs for analysis. Patients also receive surveys or questionnaires to
collect demographics, medical, family, and nutritional history, cancer predisposing risk
factors, quality of life data, and quality of care data.
After completion of study, patients are followed up periodically.
A Phase 1B Study of KRT-232 (AMG-232) in Combination With Decitabine and Venetoclax in 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. To evaluate the pharmacokinetic (PK) profiles of KRT-232 (AMG-232), venetoclax, and
decitabine when used in combination.
II. To evaluate p53 signaling induced by KRT-232 (AMG-232), venetoclax, and decitabine as
measured by MIC-1 induction.
III. To correlate KRT-232 (AMG-232), venetoclax and decitabine exposure with pharmacodynamics
endpoints (efficacy, toxicity, changes in p53 signaling).
EXPLORATORY OBJECTIVES:
I. To evaluate the response rate (RR) and progression free survival (PFS) of KRT-232
(AMG-232), venetoclax, and decitabine in acute myeloid leukemia (AML).
II. To evaluate potential predictive biomarkers of response to KRT-232 (AMG-232), venetoclax,
and decitabine in AML.
III. To evaluate the pharmacodynamic (PD) effects of KRT-232 (AMG-232), venetoclax and
decitabine in AML blasts.
IV. To determine the variability of decitabine incorporation into genomic deoxyribonucleic
acid (DNA) and correlate with systemic pharmacokinetics and exposure-response relationships.
OUTLINE: This is a dose-escalation study of navtemadlin.
Patients receive decitabine intravenously (IV) over 1 hour on days 1-10, navtemadlin orally
(PO) once daily (QD) on days 1-7, and venetoclax PO QD on days 1-21. Treatment repeats every
28 days for up to 4 cycles in patients with evidence of persistent AML.
Starting cycle 2, patients with no morphologic evidence of AML receive decitabine IV over 1
hour on days 1-5, navtemadlin PO QD on days 1-7, and venetoclax PO QD on days 1-14. Cycles
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients also undergo bone marrow aspiration and biopsy, and blood sample collection
throughout the trial.
After completion of study treatment, patients are followed up for 30 days.
A Phase I Study of FID-007 in Patients With Advanced Solid Tumors
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of FID-007 and the recommended phase II dose
(RP2D).
II. To determine the pharmacokinetics of paclitaxel, (free and total) in patients treated
with FID-007.
SECONDARY OBJECTIVES:
I. To characterize the safety and tolerability of FID-007 by assessing toxicities per Common
Terminology Criteria for Adverse Events (CTCAE) version (v.)4.3.
II. To obtain a preliminary assessment of anti-tumor activity of FID-007 via objective
radiologic tumor response using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
EXPLORATORY OBJECTIVES:
I. To evaluate in a preliminary fashion the serum concentration of total paclitaxel and free
paclitaxel, and explore potential associations with serum concentrations, efficacy and
toxicity.
OUTLINE: This is a dose escalation study.
Participants receive FID-007 intravenously (IV) over 60 minutes on days 1, 8 and 15. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up periodically.
Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients With Metastatic HER-2+ Breast Cancer, Phase III
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 reduces the risk of predefined subsequent cardiac events in patients with
metastatic breast cancer receiving trastuzumab?based HER-2 targeted therapy.
II. To evaluate if prophylactic carvedilol compared with no intervention results in a longer
time to first interruption of trastuzumab?based HER-2 targeted therapy due to either cardiac
dysfunction or events.
III. To assess whether prophylactic beta blocker therapy with carvedilol compared with no
intervention reduces the risk of subsequent cardiac dysfunction OR events in this population.
IV. To establish and prospectively collect a predefined panel of baseline core cardiovascular
measures and develop a predictive model of cardiac dysfunction.
V. To evaluate the rate of cardiac dysfunction in an observational arm consisting of
individuals otherwise eligible for the study except for use of beta blockers, angiotensin
receptor blocker (ARB), or angiotensin converting enzyme (ACE) inhibitors for other medical
reasons.
TERTIARY OBJECTIVES:
I. To evaluate the isoleucine (lle) 655 valine (Val) and and alanine (Ala)ll70 proline (Pro)
single nucleotide polymorphisms (SNPs) of the HER-2 gene as a predictive biomarker of
study-defined cardiac dysfunction.
II. To evaluate plasma neuregulin-1 at baseline and over study time as a predictive biomarker
of study-defined cardiac dysfunction.
III. To evaluate the feasibility of performing serial left ventricular strain in a National
Clinical Trials Network (NCTN) group setting, with the goal of 75% of patients contributing
both a baseline and at least one follow-up strain measurement.
IV. To bank blood for future translational medicine studies such as brain natriuretic peptide
(BNP), additional SNPs, and high sensitivity troponin.
OUTLINE: Patients are randomized to 1 of 2 arms. Patients taking beta blocker, ARB, or ACE
inhibitor at registration are assigned to Arm III.
ARM I: Patients not taking beta blocker, ARB, or ACE inhibitor at registration receive
carvedilol orally (PO) twice daily (BID). Courses repeat every 12 weeks for 108 weeks in the
absence of disease progression or unacceptable toxicity.
ARM II: Patients not taking beta blocker, ARB, or ACE inhibitor at registration receive no
study intervention for up to 108 weeks.
ARM III: Patients undergo observation for up to 108 weeks.
After completion of study, patients are followed up for up to 108 weeks.
Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma
PRIMARY OBJECTIVES:
I. To determine, in terms of progression-free survival (PFS), the extent of clinical benefit
of the addition of adjuvant radiotherapy (RT) to gross total resection (GTR) for patients
with newly diagnosed World Health Organization (WHO) grade II meningioma.
SECONDARY OBJECTIVES:
I. Overall survival (OS). II. Disease-specific survival (DSS). III. Toxicity (grade 3+,
exclusive of expected alopecia). IV. Neurocognitive function (NCF). V. Outcomes and patient
reported outcomes (PRO) measurements. VI. Adherence to protocol-specific target and normal
tissue parameters. VII. Concordance measurements of central versus parent-institution
pathology. VIII. Tissue microarray construction, and assessment of pHH3 mitotic index and
molecular correlates to OS.
OUTLINE: Patients are randomized to 1 of 2 arms after undergoing gross total resection.
ARM I: Patients undergo observation.
ARM II: Patients undergo radiation therapy 5 days a week over 6.5-7 weeks for a total of 33
fractions (59.4 Gy in 33 daily fractions of 1.8 Gy each).
After completion of study treatment, patients are followed up at 3, 6, and 12 months, every 6
months for year 2 and 3, then yearly for 10 years.
USC study investigates the benefits or health risks of vaping and smoking
Researchers at USC are seeking study participants who vape or smoke as well as non-smokers in the Los Angeles area. The purpose of the research is to study the health benefits and risks of electronic cigarettes (e-cigs). Your participation will help to better understand the potential effects of e-cigs on the human body.
Pharmacogenomics of Age-Specific, Asparaginase-Induced Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia
PRIMARY OBJECTIVES:
I. To establish the association between the SOD2 rs4880 genotypes and asparaginase-induced
hepatotoxicity in Hispanic patients.
II. To identify novel single nucleotide polymorphisms (SNPs) that are associated with
asparaginase induced hepatotoxicity.
OUTLINE:
Participants' SOD2 rs4880 SNP genotype (based on saliva from buccal swabs) will be
classified. Participants with the CC genotype will be compared to participants with the CT or
TT genotype. Buccal swabs of prospective participants' saliva will be collected when
participant achieves complete remission (during regular clinical visit). Retrospective
participants will be identified through search of pharmacy records for those who received
asparaginase within the last 5 years (2012-2017). Recurrent patients will be consented during
their regular clinical visits and samples will be collected.
Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer
PRIMARY OBJECTIVES:
I. To compare overall survival in metastatic prostate cancer patients who are randomized to
standard systemic therapy (SST) plus definitive treatment of the primary tumor versus
standard systemic therapy alone.
SECONDARY OBJECTIVES:
I. To compare overall survival in metastatic prostate cancer patients who received SST plus
surgical excision of the primary tumor versus SST alone in the subset who specify the
surgical intent stratification factor.
II. To compare the rate of symptomatic local progression between the treatment arms.
III. To compare progression-free survival (PFS) between the two treatment arms. IV. To
compare rates of progression-free survival between arms for the subsets of patients with and
without metastasis directed therapy (MDT) to oligometastatic sites.
QUALITY OF LIFE OBJECTIVES:
I. To compare between arms patient-reported urinary function and urinary bother over time
(after initiation of SST at 6 months, 1, 2, and 3 years) using the Expanded Prostate Cancer
Index Composite (EPIC) and patient-reported pain and physical functioning using the European
Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC
QLQ-C30) between patients receiving standard systemic therapy and those receiving systemic
therapy and definitive management of the primary prostate cancer.
OTHER OBJECTIVES:
I. To bank tissue and whole blood specimens for future use.
OUTLINE:
INDUCTION: Participants receive 1 of 6 acceptable forms of SST for 22-28 weeks. I.
Participants undergo a bilateral orchiectomy. II. Participants receive goserelin acetate
subcutaneously (SC) every 28 days or 12 weeks, histrelin acetate SC every 12 months,
leuprolide acetate SC or intramuscularly (IM) every 1, 3, 4, or 6 months, and triptorelin
every 1, 3, or 6 months.
III. Participants receive goserelin acetate SC every 28 days or 12 weeks, histrelin acetate
SC every 12 months, leuprolide acetate SC or IM every 1, 3, 4, or 6 months, and triptorelin
every 1, 3, or 6 months. Participants also receive nilutamide orally (PO) daily, flutamide PO
every 8 hours, and bicalutamide PO daily.
IV. Participants receive degarelix via injection for 2 doses and then every 28 days.
V. Participants receive nilutamide PO daily, flutamide PO every 8 hours, and bicalutamide PO
daily. Participants also receive docetaxel over 1 hour every 3 weeks with or without
prednisone PO every 12 hours.
VI. Participants receive nilutamide PO daily, flutamide PO every 8 hours, and bicalutamide PO
daily. Participants also receive abiraterone PO daily or prednisone PO every 12 hours.
After completion of 22-28 weeks of SST, participants are then randomized to 1 of 2 arms.
ARM I: Participants receive 1 acceptable form of SST as in Induction except for treatment
with docetaxel and prednisone.
ARM II: Participants receive 1 acceptable form of SST as in Induction except for treatment
with docetaxel and prednisone. Participants undergo prostatectomy within 8 weeks after
randomization or radiation therapy within 4 weeks of randomization.
After completion of study treatment, participants are followed up for 8 years.
Phase II Multi-Institutional Study of Low-Dose (2Gy) Palliative Radiotherapy in the Treatment of Symptomatic Bone Metastases From Multiple Myeloma
PRIMARY OBJECTIVES:
I. To determine whether treatment with 2 Gy x 2 to a painful myeloma bone lesion achieves
patient-reported pain reduction comparable to current standard of care at 4 weeks.
SECONDARY OBJECTIVES:
I. To assess quality of life (QOL) in patients treated with 2 Gy x 2 to painful myeloma bone
lesions.
II. To quantify analgesia use/reduction following 2 Gy x 2 to a painful myeloma bone lesion.
All opioid analgesia use will be converted into morphine equivalent in order to compare
across the entire population.
III. To measure time to pain relief and duration of pain relief with 2 Gy x 2.
EXPLORATORY OBJECTIVES:
I. To record cytogenetics and International Myeloma Working Group (IMWG) response criteria at
diagnosis and prior to and following radiotherapy (RT).
OUTLINE:
Patients receive low-dose radiation therapy at consecutive business days 1 and 2 in the
absence of disease progression or unacceptable toxicity. Patients with no pain relief may
receive additional radiotherapy at 4 weeks following initial radiotherapy.
After completion of study treatment, patients are followed up at 2, 4, and 8 weeks and also
at 6 months.
SIMCAP (Surgery in Metastatic Carcinoma of Prostate): Phase 2.5 Multi-Institution Randomized Prospective Clinical Trial Evaluating the Impact of Cytoreductive Radical Prostatectomy Combined With Best Systemic Therapy on Oncologic and Quality of Life Outcomes in Men With Newly Diagnosed Metastatic Prostate Cancer
PRIMARY OBJECTIVES:
I. To assess the clinical benefit of combining radical surgery cytoreductive radical
prostatectomy (CRP) - with the best systemic therapy (BST) in men with newly diagnosed
clinical metastatic prostate cancer (mPCa).
SECONDARY OBJECTIVES:
I. To determine the impact of CRP+BST on time to biochemical progression, cancer-specific
survival, complication rates, and quality of life (QOL) in patients with mPCa.
II. To determine the transcription levels of bone morphogenetic protein -6 (BMP-6) and
transforming growth factor-beta (TGF-?).
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive antiandrogen therapy with or without docetaxel at the discretion
of the treating physician.
ARM II: Participants receive antiandrogen therapy for at least 1 month, then undergo
cytoreductive radical prostatectomy. Participants continue antiandrogen therapy and may
receive docetaxel prior to surgery at the discretion of the treating physician.
After completion of study treatment, patients are followed up every 6 months from time of
progression.
A Phase 2 Study of Ibrutinib and Blinatumomab in Relapsed and Refractory B-Cell Acute Lymphoblastic Leukemia
PRIMARY OBJECTIVES:
I. To evaluate the efficacy of ibrutinib and blinatumomab in patients with relapsed or
refractory B acute lymphoblastic leukemia (B-ALL) as measured by complete response (CR) rate.
SECONDARY OBJECTIVES:
I. To further examine the efficacy and safety of ibrutinib and blinatumomab in patients with
relapsed or refractory B-ALL as measured by overall response rate (ORR, defined as CR plus CR
with incomplete count recovery [CRi]), relapse free survival (RFS), overall survival (OS),
minimal residual disease (MRD) response, proportion of patients bridged to allogeneic
hematopoietic cell transplant (allo-HCT), and toxicity.
Characterization of T-cell Repertoire in Patients With AML Undergoing HSCT Through Next-Generation Sequencing of T Cell Receptor Alpha (TCRA) and T Cell Receptor Beta (TCRB) Genes
PRIMARY OBJECTIVES:
I. Characterize the T cell receptor (TCR) repertoire in acute myeloid leukemia (AML) patients
before and after receiving hematologic stem cell transplantation (HSCT).
II. Identify molecular changes (germline variants and somatic mutations) that contribute to
shaping the TCR repertoire.
OUTLINE:
Patents undergo collection of blood samples before, on day 100, and 1 year after HSCT. Donors
undergo collection of blood at the time of HSCT for ribonucleic acid (RNA)-based next
generation sequencing of TCRA and TCRB genes.
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