Trial record 1 of 1 for:    BPX-201
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Safety Study of BPX-201 Dendritic Cell Vaccine Plus AP1903 in Metastatic Castrate Resistent Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Bellicum Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Bellicum Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01823978
First received: March 21, 2013
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

This is a Phase I, non-randomized, dose escalation study of the safety, biomarkers, and preliminary efficacy of dendritic cell vaccine, BPX-201, plus activating agent, AP1903, in patients with metastatic castrate resistant prostate cancer.


Condition Intervention Phase
Castrate Resistent Prostate Cancer
Biological: BPX-201 vaccine plus AP1903
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of BPX-201 Vaccine Plus AP1903 in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Resource links provided by NLM:


Further study details as provided by Bellicum Pharmaceuticals:

Primary Outcome Measures:
  • Number of Participants with adverse events as a measure of safety and tolerability [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Safety will be measured through the monitoring of AEs, clinical laboratory parameters (hematology, serum chemistry, and urinalysis), vital sign measurements, and physical examinations.


Secondary Outcome Measures:
  • prostatic specific antigen [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Measure PSA response and PSA doubling time as measured from PSA nadir through 12 weeks

  • Progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Reduction in circulating tumor cells [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Change from baseline in number of circulating tumor cells

  • Response to chemotherapy after vaccine [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Response to chemotherapy upon progression


Estimated Enrollment: 18
Study Start Date: April 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BPX-201
BPX-201 vaccine plus AP1903
Biological: BPX-201 vaccine plus AP1903
The trial design consists of 3 cohorts of 6 patients each, receiving escalating doses of BPX-201 of 10 million (M), 20M and 40M cells, respectively. Dose escalation will occur according to a 3+3 design. Patients will receive administration of BPX-201 every other week for 6 cycles (1 cycle equals 2 weeks). Approximately 1.6 mL of BPX-201 will be administered as 8 intradermal injections (200μL each) at each treatment visit. On the day following each vaccination, a single 40 mg dose of the activating agent, AP1903, will be administered via intravenous (IV) infusion over 2 hours.

Detailed Description:

This is a Phase I study of therapeutic vaccine, BPX-201, plus activating agent, AP1903, in patients with mCRPC. Patients will be screened within 8 weeks prior to first vaccine administration (4 weeks prior to leukapheresis). The trial design consists of 3 cohorts of 6 patients each, receiving escalating doses of BPX-201 of 10 million (M), 20M and 40M cells, respectively. Dose escalation will occur according to a 3+3 design. Patients will receive administration of BPX-201 every other week for 6 cycles (1 cycle equals 2 weeks). Approximately 1.6 mL of BPX-201 will be administered as 8 intradermal injections (200μL each) at each treatment visit. On the day following each vaccination, a single 40 mg dose of the activating agent, AP1903, will be administered via intravenous (IV) infusion over 2 hours.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent
  2. 18 years of age or older
  3. Histologically confirmed, metastatic prostate cancer (positive bone scan and/or measurable disease on CT scan and/or MRI of the abdomen and pelvis).
  4. Progressive disease after androgen deprivation, as defined by Prostate Cancer Working Group 2 and/or Response Evaluation Criteria in Solid Tumors criteria
  5. Laboratory requirements:

    • Absolute neutrophil count (ANC) ≥ 1500/μL
    • Bilirubin < 1.5 x ULN
    • Hemoglobin > 8 g/dL
    • PSA > 2 ng/mL
    • Platelets > 100,000/µL
    • AST and ALT < 2.5 x ULN
    • Creatinine clearance ≥ 60mL/min
    • Testosterone < 50 ng/dL
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2 and life expectancy > 12 weeks
  7. Patients receiving any other hormonal therapy, including any dose of megestrol acetate (Megace), Proscar (finasteride), any herbal product known to decrease PSA levels (e.g. Saw Palmetto, PC-SPES), or agents such as abiraterone, TAK700, MDV3100 as well as any systemic corticosteroid use, must discontinue the agent for at least four weeks prior to study treatment. Progressive disease as defined above must be documented after discontinuation of any hormonal therapy (with the exception of a LHRH agonist).
  8. Prior radiation therapy must be completed > 4 weeks prior to enrollment and the patient must have recovered from all toxicity. Prior radiopharmaceuticals (strontium, samarium) must be completed ≥ 8 weeks prior to enrollment.
  9. Because of the unknown potential risk to a gamete and/or developing embryo from these investigational therapies, patients must agree to use adequate contraception (barrier method for males) for the duration of study participation, and for three months after discontinuing therapy.

Exclusion Criteria:

  1. Prior chemotherapy for prostate cancer, with the exception of neo-adjuvant chemotherapy, because of the potential effect of chemotherapy on the immune system.
  2. Prior sipuleucel-T treatment or investigational immunotherapy.
  3. Prostate cancer pain requiring regularly scheduled narcotics.
  4. Current treatment with systemic steroid therapy (inhaled/topical steroids are acceptable). Systemic corticosteroids must be discontinued for at least 4 weeks prior to first treatment.
  5. Clinically active autoimmune disease.
  6. Diagnosis of prostate cancer with neuroendocrine differentiation
  7. Known presence of central nervous system metastases, pleural effusions or ascites
  8. Medical or psychiatric illness that would, in the opinion of the investigator, preclude participation in the study or the ability of patients to provide informed consent for themselves.
  9. Cardiovascular disease that meets one of the following: congestive heart failure (New York Heart Association Class III or IV), active angina pectoris, or recent myocardial infarction (within the last 6 months).
  10. Concurrent or prior malignancy except for the following:

    • Adequately treated basal or squamous cell skin cancer
    • Adequately treated stage I or II cancer from which the patient is currently in complete remission
    • Any other cancer from which the patient has been disease-free for 5 years
  11. Known HIV or other history of immunodeficiency disorder.
  12. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or medical (e.g. infectious) illness.
  13. Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of BPX-201 and AP1903 hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea.
  14. Any non-oncology vaccine therapy used for prevention of infectious diseases for up to 1 month before BPX-201
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01823978

Locations
United States, Alabama
UAB Comprehensive Cancer Center Recruiting
Birmingham, Alabama, United States, 35249
Contact: Dayle Craig, RN    205-975-8080    dc0350@uab.edu   
Principal Investigator: Guru P Sonpavde, MD         
United States, Texas
Baylor Charles Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Erica Goetz    214-818-8325      
Principal Investigator: Thomas Hutson         
Sponsors and Collaborators
Bellicum Pharmaceuticals
Investigators
Principal Investigator: Lawrence Fong, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Bellicum Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01823978     History of Changes
Other Study ID Numbers: BP-PC-002
Study First Received: March 21, 2013
Last Updated: February 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bellicum Pharmaceuticals:
metastatic
castration resistant prostate cancer
Therapeutic Vaccine
Dendritic cell
BPX-201
BPX201
AP1903

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 26, 2014