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| ID | Type | Description | Link |
|---|---|---|---|
| UCSF-0155-01 | |||
| NCI-2617 | |||
| UCSF-01554 | |||
| CDR0000069047 | Registry Identifier | PDQ (Physician Data Query) |
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Phase II trial to study the effectiveness of APC8015 combined with bevacizumab in treating patients who have undergone radiation therapy and/or surgery and who have progressive prostate cancer. Biological therapies such as APC8015 use different ways to stimulate the immune system and stop cancer cells from growing. Monoclonal antibodies such as bevacizumab can locate tumor cells and kill them without harming normal cells. Combining monoclonal antibody therapy with biological therapy may kill more cancer cells.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Biological |
| ||
| prostatic acid phosphatase-sargramostim fusion protein |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
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:
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:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
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
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Eric J. Small, MD | University of California, San Francisco | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
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| Biological |
|
| sipuleucel-T | Biological |
|
| therapeutic autologous dendritic cells | Biological |
|
| in vitro-treated peripheral blood stem cell transplantation | Procedure |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| C511774 | sipuleucel-T |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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