Phase 2
Completed N=2
Sipuleucel-T With or Without Tasquinimod in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
Hormone-Resistant Prostate Cancer · Metastatic Prostate Carcinoma · Recurrent Prostate Carcinoma · Stage IV Prostate Cancer
Source: ClinicalTrials.gov NCT02159950 ↗
Enrolled (actual)
2
Serious AEs
50.0%
Results posted
May 2016
Primary outcomePrimary: Change in Immune Response Assessed by IFN-g ELISPOT Specific for PA2024
Summary
This randomized phase II trial studies how well sipuleucel-T with or without tasquinimod works in treating patients with hormone-resistant prostate cancer that has spread to other parts of the body. Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. Tasquinimod may stop the growth of prostate cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether sipuleucel-T is more effective with or without tasquinimod in treating prostate cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Immune Response Assessed by IFN-g ELISPOT Specific for PA2024 |
— | — |
| SECONDARY Change in PSA Response |
— | — |
| SECONDARY Duration of PSA Response |
— | — |
| SECONDARY Frequency of Toxicities Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4 |
1; 1 | — |
| SECONDARY Immune Response |
— | — |
| SECONDARY Immune Response (Arm 2 Only) |
— | — |
| SECONDARY Objective Response Rates (Partial or Complete) |
— | — |
| SECONDARY Overall Survival |
— | — |
| SECONDARY Progression-free Survival |
— | — |
| SECONDARY Time to PSA Progression |
— | — |
Eligibility Criteria
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 = = 50 mL/min (please use institutional formula)
- Prothrombin time (PT)/international normalized ratio (INR) = = 1+, 24 hour urine protein should be obtained and should be 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
Data sourced from ClinicalTrials.gov (NCT02159950). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.