- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02159950
Sipuleucel-T With or Without Tasquinimod in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
A Phase II Randomized Open Label Study of Sipuleucel-T vs. Sipuleucel-T and Tasquinimod in Patients With Metastatic Castrate-Resistant Prostate Cancer (CRPC)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To determine whether tasquinimod augments immune response to sipuleucel-T.
SECONDARY OBJECTIVES:
I. To assess the safety and tolerability of the combination of sipuleucel-T and tasquinimod in patients with castration-resistant metastatic prostate cancer.
II. To obtain preliminary evidence of the clinical benefit of the combination of sipuleucel-T and tasquinimod; to include changes in prostate specific antigen (PSA) over time, and duration of progression-free survival/overall survival.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive sipuleucel-T intravenously (IV) over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive tasquinimod orally (PO) once daily (QD) beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.
After completion of study treatment, patients are followed up every 3 months for up to 3 years.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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New York
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Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Metastatic asymptomatic or minimally symptomatic castration-resistant prostate cancer (CRPC) patients who are eligible for sipuleucel-T
- Disease progression by PSA criteria (PSA Working Group Consensus Criteria Eligibility) and/or Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- Life expectancy >= 6 months
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Hemoglobin >= 100 g/L (>= 10 g/dL)
- Leukocytes >= 3,000/mm^3
- Absolute neutrophil count >= 1,500/mm^3
- Platelets >= 100,000/mm^3
- Total bilirubin =< 1.5 x laboratory upper limit of normal
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x laboratory upper limit of normal
- Creatinine =< 1.5 x laboratory upper limit of normal or calculated creatinine clearance of >= 50 mL/min (please use institutional formula)
- Prothrombin time (PT)/international normalized ratio (INR) =< 1.5
- Urine protein < 1+; if >= 1+, 24 hour urine protein should be obtained and should be < 1000 mg
- Central nervous system (CNS): no recent history (within 6 month) of cerebrovascular accident, transient ischemic attacks, central nervous system or brain metastases
- Ability to understand and the willingness to sign a written informed consent document
- Patient verbalizes the ability to swallow and retain oral medication
- Subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
- Patients who have received systemic steroids within 4 weeks prior to starting study treatment
- Patients who have received prior immunotherapies
- History of therapy for an autoimmune disorder
- Patients receiving any other investigational agents
- Any medical condition that would preclude adequate evaluation of the safety and toxicity of the study combination
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Association class II, III, or IV), angina pectoris requiring nitrate therapy, recent myocardial infarction (less than the last 6 months), cardiac arrhythmia, history of cerebrovascular accident (CVA) within 6 months; no uncontrolled hypertension (defined as blood pressure of > 160/90 mmHg) on medication or, history of peripheral vascular disease
- Ongoing treatment with warfarin unless the international normalized ratio (INR) is well controlled and below 4
- History of psychiatric illness or social situations that would limit compliance with study requirements
- History of pancreatitis
- Human immunodeficiency virus (HIV)-positive patients receiving combination antiretroviral therapy are ineligible
- Systemic exposure to ketoconazole or other strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) isoenzyme inhibitors or inducers within 14 days prior to the start of study treatment; systemic exposure to aminodarone is not allowed within 1 year prior to the start of study treatment
- Ongoing treatment with sensitive cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2) substrate or CYP1A2 substrate with narrow therapeutic range at the start of study treatment
- Ongoing treatment with CYP3A4 substrate with narrow therapeutic range at the start of study treatment
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 of therapy
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I (sipuleucel-T)
Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
|
Correlative studies
Given IV
Other Names:
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Experimental: Arm II (tasquinimod, sipuleucel-T)
Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Patients continue on tasquinimod treatment after day 42 until disease progression.
|
Correlative studies
Given IV
Other Names:
Given PO
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Immune Response Assessed by IFN-g ELISPOT Specific for PA2024
Time Frame: Baseline up to 50 weeks
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Baseline up to 50 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: Up to 3 years
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Up to 3 years
|
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Change in PSA Response
Time Frame: Baseline to up to 3 years
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PSA doubling time, PSA slope
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Baseline to up to 3 years
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Duration of PSA Response
Time Frame: Up to 3 years
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Up to 3 years
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Frequency of Toxicities Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4
Time Frame: Up to 3 years
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The frequency of participants with toxicities will be tabulated by grade across all dose levels and courses.
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Up to 3 years
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Immune Response
Time Frame: Week 6
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Week 6
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Immune Response
Time Frame: Week 10
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Week 10
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Immune Response
Time Frame: Week 26
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Week 26
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Immune Response
Time Frame: Week 50
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Week 50
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Immune Response (Arm 2 Only)
Time Frame: Week 0
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Week 0
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Objective Response Rates (Partial or Complete)
Time Frame: Up to 3 years
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Up to 3 years
|
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Progression-free Survival
Time Frame: Up to 3 years
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Up to 3 years
|
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Time to PSA Progression
Time Frame: Up to 3 years
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Up to 3 years
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effects of Tasquinimod on the Inhibition of Immune Cells
Time Frame: Up to week 50
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Up to week 50
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I 250813 (Other Identifier: Roswell Park Cancer Institute)
- NCI-2014-01184 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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