Status:
COMPLETED
MTD Study of Vaccine BP-GMAX-CD1 Plus AP1903 to Treat Castrate Resistant Prostate Cancer
Lead Sponsor:
Bellicum Pharmaceuticals
Collaborating Sponsors:
M.D. Anderson Cancer Center
The University of Texas Health Science Center, Houston
Conditions:
Castrate Resistant Prostate Cancer (CRPC)
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase I, non-randomized, multiple-dose, 3+3 dose-escalation study of the safety, pharmacokinetics, biomarkers, preliminary efficacy and patient-reported outcomes of therapeutic vaccine, BPX-...
Detailed Description
Patients will be screened within 6 weeks prior to Week 1. A total of 3 cohorts, consisting of 3 to 6 patients each, are planned to receive five to eight intradermal (ID) injections totaling 1 mL up to...
Eligibility Criteria
Inclusion
- Males ≥ 18 years of age
- Histological diagnosis of adenocarcinoma of the prostate
- Documented evidence of distant metastasis of disease
- No more than 1 prior chemotherapeutic, biologic or combination treatment regimen (including vitamin D analogues) for CRPC. If previously treated, patients must be recovered from all toxicities prior to entry into the study.
- Patients must have current or historical evidence of disease progression concomitant with surgical (orchiectomy) or medical castration (LHRH analogue); anti-androgen withdrawal (4 weeks for flutamide and 6 weeks for nilutamide or bicalutamide) is necessary only for patients on antiandrogens and a duration of response to antiandrogens \> 3months;
- Testosterone \< 50 ng/dL achieved via medical or surgical castration. Patients receiving medical castration therapy must continue such therapy throughout the study.
- Adequate hematologic, renal and liver function:
- Negative serology tests for human immunodeficiency virus (HIV-1 and 2), human T-cell lymphotropic virus (HTLV-1), hepatitis B surface antigen (HBsAg) and hepatitis C (HCV)
- Karnofsky Performance Score (KPS) ≥ 70%
- Life expectancy \> 6 months
- Written informed consent obtained prior to the initiation of study procedures
Exclusion
- The presence of brain metastases, pleural effusions or ascites
- Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography \> 50%), or spinal cord compression
- A history of stage III or greater cancer, excluding prostate cancer. Basal or squamous cell skin cancers must have been adequately treated and the patient must be disease-free at the time of registration. Patients with a history of stage I or II other cancers must have been adequately treated and been disease-free for 3 years at the time of registration.
- More than 1 prior chemotherapy, biologic or combination treatment regimen (including vitamin D analogues) for CRPC
- Any treatment with radiopharmaceuticals, e.g. Strontium-89 and Samarium-153
- Ketoconazole or antiandrogens (flutamide, nilutamide, bicalutamide) within 2 weeks prior to registration. Patients who demonstrate an anti-androgen withdrawal response, defined as a \> 25% drop in PSA within 4 weeks (flutamide) or 6 weeks (nilutamide, bicalutamide) of stopping a non-steroidal anti-androgen, are not eligible until the PSA rises above the nadir observed after anti-androgen withdrawal.
- Initiation of bisphosphonate therapy within 28 days prior to registration. Patients taking bisphosphonates should not have their dosing regimen altered unless medically warranted.
- A requirement for systemic steroid or other immunosuppressive therapy for any reason.
- Treatment with any of the following medications or interventions \< 28 days prior to Screening
- Treatment with any investigational vaccine within 2 years prior to Screening, or treatment with any other investigational product within 28 days prior to Screening
- Any antibiotic therapy or infection within 1 week prior to Screening, including unexplained fever (temperature ≥ 100.5F or 38.1C)
- History of autoimmune disease
- Serious ongoing chronic or acute illness
- Any medical intervention or other condition which, in the opinion of the Principal Investigator and/or the Bellicum Medical Monitor, could compromise adherence with study requirements
- Other Criteria Apply however are not listed
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00868595
Start Date
April 1 2009
End Date
March 1 2012
Last Update
October 8 2019
Active Locations (1)
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1
University of Texas Health Science Center Houston, CRU
Houston, Texas, United States, 77030