APC8015 and Bevacizumab in Treating Patients With Prostate Cancer
A Phase II Study Of Prostatic Acid Phosphatase-Pulsed Dendritic Cells (Provenge) In Combination With Bevacizumab In Patients With Serologic Progression Of Prostate Cancer After Definitive Local Therapy
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
I. Determine the efficacy of APC8015 (Provenge) and bevacizumab, in terms of decline in prostate-specific antigen (PSA) value and effect on PSA doubling time, in patients with progressive prostate cancer.
II. Determine any immune response in patients treated with this regimen. III. Determine the safety of this regimen in these patients.
OUTLINE:
Autologous dendritic cells (DCs) are harvested and pulsed with prostatic acid phosphatase-sargramostim fusion protein to produce APC8015 (Provenge). Patients receive APC8015 IV over 30 minutes and bevacizumab IV over 30-60 minutes on day 1. Treatment repeats every 14 days for 3 courses. Patients continue to receive bevacizumab alone every 14 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every month.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
California
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San Francisco, California, United States, 94115
- UCSF Comprehensive Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
- Any T, any N, M0
Received prior therapy comprising one of the following regimens for primary prostate cancer:
- External beam radiotherapy
- Brachytherapy with or without pelvic external beam radiotherapy
- Cryosurgery
Radical prostatectomy with or without adjuvant or salvage radiotherapy
Adjuvant or salvage radiotherapy after radical prostatectomy is allowed provided the following criteria is met:
- PSA was never greater than 6.0 ng/mL
- At least 3 months since androgen deprivation
- Elevated PSA (0.4-6.0 ng/mL) that has increased on 2 measurements taken at least 2 weeks apart
- No history of or radiological evidence of current CNS disease (e.g., primary brain tumor, seizures not controlled with standard medical therapy, or brain metastases)
PATIENT CHARACTERISTICS:
Performance status:
- ECOG 0-1
Life expectancy:
- At least 12 months
Hematopoietic:
- WBC greater than 2,500/mm^3
- Absolute neutrophil count greater than 1,000/mm^3
- Platelet count greater than 100,000/mm^3
- No prior bleeding disorder
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- AST no greater than 2 times ULN
- Hepatitis B and C negative
Renal:
- Creatinine no greater than 2 times ULN
- BUN no greater than 2 times ULN
Cardiovascular:
- No clinically significant cardiovascular disease
- No New York Heart Association grade II-IV heart disease (symptomatic congestive heart failure)
- No unstable angina pectoris
- No serious cardiac arrhythmia requiring medication
- No uncontrolled hypertension
- No prior myocardial infarction
- No grade II or greater peripheral vascular disease within the past year
- No prior deep vein thrombosis
Other:
- Fertile patients must use effective contraception
- HIV and HTLV I and II negative
- No other uncontrolled illness, underlying medical condition, psychiatric illness, or social situation that would preclude study participation
- No ongoing or active infection
- No active autoimmune disease requiring treatment
- No significant traumatic injury within the past 4 weeks
- No serious nonhealing wound, ulcer, or bone fracture
No other "currently active" malignancy except nonmelanoma skin cancer
- Not "currently active" if considered by physician as having less than 30% risk of relapse after completion of therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunotherapy
- No prior anti-vascular endothelial growth factor therapy
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- No prior hormonal therapy (e.g., luteinizing hormone-releasing hormone [LHRH] agonists or antagonists, antiandrogens, estrogens, megestrol, or PC-SPES) for progressive disease
- Prior hormonal therapy in adjuvant or neoadjuvant setting as primary therapy allowed if at least 3 months since androgen deprivation
- No concurrent systemic steroid therapy (inhaled or topical steroids allowed)
Radiotherapy:
- No concurrent radiotherapy
Surgery:
- At least 4 weeks since prior major surgery, including open biopsy or needle biopsy of liver
- No concurrent major surgery
Other:
- At least 10 days since prior aspirin
- At least 10 days since prior oral or parenteral anticoagulants except to maintain patency of pre-existing permanent indwelling IV catheters
- No concurrent aspirin
- No concurrent oral or parenteral anticoagulants except to maintain patency of pre-existing permanent indwelling IV catheters
- No other concurrent experimental or commercial agents or therapies for prostate cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm I
Autologous dendritic cells (DCs) are harvested and pulsed with prostatic acid phosphatase-sargramostim fusion protein to produce APC8015 (Provenge).
Patients receive APC8015 IV over 30 minutes and bevacizumab IV over 30-60 minutes on day 1.
Treatment repeats every 14 days for 3 courses.
Patients continue to receive bevacizumab alone every 14 days in the absence of disease progression or unacceptable toxicity.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
- Sargramostim
Other Study ID Numbers
- NCI-2012-02427
- UCSF-0155-01
- NCI-2617
- UCSF-01554
- CDR0000069047 (Registry Identifier: PDQ (Physician Data Query))
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