Sipuleucel-T With or Without Tasquinimod in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 60
Inclusion Criteria
- 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
- 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
- ...
- 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
- 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
- Creatinine =< 1.5 x laboratory upper limit of normal or calculated creatinine clearance of >= 50 mL/min (please use institutional formula)
- Central nervous system (CNS): no recent history (within 6 month) of cerebrovascular accident, transient ischemic attacks, central nervous system or brain metastases
- Prothrombin time (PT)/international normalized ratio (INR) =< 1.5
- Absolute neutrophil count >= 1,500/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
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Urine protein < 1+; if >= 1+, 24 hour urine protein should be obtained and should be < 1000 mg
- Platelets >= 100,000/mm^3
- Leukocytes >= 3,000/mm^3
- Life expectancy >= 6 months
- Hemoglobin >= 100 g/L (>= 10 g/dL)
- Ability to understand and the willingness to sign a written informed consent document
- Patient verbalizes the ability to swallow and retain oral medication
Exclusion Criteria
- Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug
- 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
- Patients who have received prior immunotherapies
- ...
- Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug
- 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
- Patients who have received prior immunotherapies
- History of psychiatric illness or social situations that would limit compliance with study requirements
- Any medical condition that would preclude adequate evaluation of the safety and toxicity of the study combination
- History of pancreatitis
- Ongoing treatment with warfarin unless the international normalized ratio (INR) is well controlled and below 4
- 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
- Human immunodeficiency virus (HIV)-positive patients receiving combination antiretroviral therapy are ineligible
- Ongoing treatment with CYP3A4 substrate with narrow therapeutic range at the start of study treatment
- Unwilling or unable to follow protocol requirements
- History of therapy for an autoimmune disorder
- Patients who have received systemic steroids within 4 weeks prior to starting study treatment
- 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
- Patients receiving any other investigational agents
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 of therapy
Summary
- Conditions
- Hormone-Resistant Prostate Cancer
- Metastatic Prostate Carcinoma
- Recurrent Prostate Carcinoma
- Stage IV Prostate Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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 prelimin...
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.
Inclusion Criteria
- 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
- 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
- ...
- 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
- 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
- Creatinine =< 1.5 x laboratory upper limit of normal or calculated creatinine clearance of >= 50 mL/min (please use institutional formula)
- Central nervous system (CNS): no recent history (within 6 month) of cerebrovascular accident, transient ischemic attacks, central nervous system or brain metastases
- Prothrombin time (PT)/international normalized ratio (INR) =< 1.5
- Absolute neutrophil count >= 1,500/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
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Urine protein < 1+; if >= 1+, 24 hour urine protein should be obtained and should be < 1000 mg
- Platelets >= 100,000/mm^3
- Leukocytes >= 3,000/mm^3
- Life expectancy >= 6 months
- Hemoglobin >= 100 g/L (>= 10 g/dL)
- Ability to understand and the willingness to sign a written informed consent document
- Patient verbalizes the ability to swallow and retain oral medication
Exclusion Criteria
- Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug
- 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
- Patients who have received prior immunotherapies
- ...
- Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug
- 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
- Patients who have received prior immunotherapies
- History of psychiatric illness or social situations that would limit compliance with study requirements
- Any medical condition that would preclude adequate evaluation of the safety and toxicity of the study combination
- History of pancreatitis
- Ongoing treatment with warfarin unless the international normalized ratio (INR) is well controlled and below 4
- 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
- Human immunodeficiency virus (HIV)-positive patients receiving combination antiretroviral therapy are ineligible
- Ongoing treatment with CYP3A4 substrate with narrow therapeutic range at the start of study treatment
- Unwilling or unable to follow protocol requirements
- History of therapy for an autoimmune disorder
- Patients who have received systemic steroids within 4 weeks prior to starting study treatment
- 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
- Patients receiving any other investigational agents
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 of therapy
Tracking Information
- NCT #
- NCT02159950
- Collaborators
- National Cancer Institute (NCI)
- Active Biotech AB
- Investigators
- Principal Investigator: Saby George Roswell Park Cancer Institute
- Saby George Roswell Park Cancer Institute