Recruitment

Recruitment Status
Completed
Estimated Enrollment
60

Inclusion Criteria

Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x laboratory upper limit of normal
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
Platelets >= 100,000/mm^3
...
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x laboratory upper limit of normal
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
Platelets >= 100,000/mm^3
Total bilirubin =< 1.5 x laboratory upper limit of normal
Life expectancy >= 6 months
Absolute neutrophil count >= 1,500/mm^3
Creatinine =< 1.5 x laboratory upper limit of normal or calculated creatinine clearance of >= 50 mL/min (please use institutional formula)
Ability to understand and the willingness to sign a written informed consent document
Leukocytes >= 3,000/mm^3
Central nervous system (CNS): no recent history (within 6 month) of cerebrovascular accident, transient ischemic attacks, central nervous system or brain metastases
Patient verbalizes the ability to swallow and retain oral medication
Prothrombin time (PT)/international normalized ratio (INR) =< 1.5
Disease progression by PSA criteria (PSA Working Group Consensus Criteria Eligibility) and/or Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Metastatic asymptomatic or minimally symptomatic castration-resistant prostate cancer (CRPC) patients who are eligible for sipuleucel-T
Urine protein < 1+; if >= 1+, 24 hour urine protein should be obtained and should be < 1000 mg
Hemoglobin >= 100 g/L (>= 10 g/dL)
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Exclusion Criteria

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 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
Patients receiving any other investigational agents
Any medical condition that would preclude adequate evaluation of the safety and toxicity of the study combination
History of psychiatric illness or social situations that would limit compliance with study requirements
History of pancreatitis
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 warfarin unless the international normalized ratio (INR) is well controlled and below 4
Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug
Ongoing treatment with CYP3A4 substrate with narrow therapeutic range at the start of study treatment
Unwilling or unable to follow protocol requirements
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 of therapy
Patients who have received prior immunotherapies
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
History of therapy for an autoimmune disorder

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

Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x laboratory upper limit of normal
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
Platelets >= 100,000/mm^3
...
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x laboratory upper limit of normal
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
Platelets >= 100,000/mm^3
Total bilirubin =< 1.5 x laboratory upper limit of normal
Life expectancy >= 6 months
Absolute neutrophil count >= 1,500/mm^3
Creatinine =< 1.5 x laboratory upper limit of normal or calculated creatinine clearance of >= 50 mL/min (please use institutional formula)
Ability to understand and the willingness to sign a written informed consent document
Leukocytes >= 3,000/mm^3
Central nervous system (CNS): no recent history (within 6 month) of cerebrovascular accident, transient ischemic attacks, central nervous system or brain metastases
Patient verbalizes the ability to swallow and retain oral medication
Prothrombin time (PT)/international normalized ratio (INR) =< 1.5
Disease progression by PSA criteria (PSA Working Group Consensus Criteria Eligibility) and/or Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Metastatic asymptomatic or minimally symptomatic castration-resistant prostate cancer (CRPC) patients who are eligible for sipuleucel-T
Urine protein < 1+; if >= 1+, 24 hour urine protein should be obtained and should be < 1000 mg
Hemoglobin >= 100 g/L (>= 10 g/dL)
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Exclusion Criteria

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 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
Patients receiving any other investigational agents
Any medical condition that would preclude adequate evaluation of the safety and toxicity of the study combination
History of psychiatric illness or social situations that would limit compliance with study requirements
History of pancreatitis
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 warfarin unless the international normalized ratio (INR) is well controlled and below 4
Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug
Ongoing treatment with CYP3A4 substrate with narrow therapeutic range at the start of study treatment
Unwilling or unable to follow protocol requirements
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 of therapy
Patients who have received prior immunotherapies
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
History of therapy for an autoimmune disorder

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
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