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| Sponsor: | UCSF Helen Diller Family Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00027599 |
Purpose
RATIONALE: 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.
PURPOSE: 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: bevacizumab Biological: prostatic acid phosphatase-sargramostim fusion protein Biological: sipuleucel-T Biological: therapeutic autologous dendritic cells Procedure: in vitro-treated peripheral blood stem cell transplantation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | 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 Start Date: | December 2001 |
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Received prior therapy comprising one of the following regimens for primary prostate cancer:
Radical prostatectomy with or without adjuvant or salvage radiotherapy
Adjuvant or salvage radiotherapy after radical prostatectomy is allowed provided the following criteria is met:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
No other "currently active" malignancy except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, California | |
| UCSF Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| Study Chair: | Eric J. Small, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000069047, UCSF-0155-01, NCI-2617, UCSF-01554 |
| Study First Received: | December 7, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00027599 History of Changes |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer |
stage III prostate cancer stage IV prostate cancer recurrent prostate cancer |
|
Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Growth Substances Physiological Effects of Drugs Urogenital Neoplasms Bevacizumab Genital Diseases, Male |
Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Prostatic Neoplasms |