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Spots Global Cancer Trial Database for APC8015 and Bevacizumab in Treating Patients With Prostate Cancer

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Trial Identification

Brief Title: APC8015 and Bevacizumab in Treating Patients With Prostate Cancer

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 ID: NCT00027599

Conditions

Prostate Cancer

Study Description

Brief Summary: 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.

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.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

UCSF Comprehensive Cancer Center, San Francisco, California, United States

Contact Details

Name: Eric J. Small, MD

Affiliation: University of California, San Francisco

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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