|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
UCSF Helen Diller Family Comprehensive Cancer Center 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 |
Drug: bevacizumab Drug: prostatic acid phosphatase-sargramostim fusion protein Drug: sipuleucel-T Drug: therapeutic autologous dendritic cells Procedure: in vitro-treated peripheral blood stem cell transplantation |
Phase II |
| MedlinePlus related topics: | Cancer Prostate Cancer |
| ChemIDplus related topics: | Sargramostim Granulocyte-macrophage colony-stimulating factor Bevacizumab Sipuleucel-T Provenge |
| 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 | |||||
| UCSF Helen Diller Family Comprehensive Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Eric J. Small, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000069047, UCSF-0155-01, NCI-2617, UCSF-01554 |
| First Received: | December 7, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00027599 |
| Health Authority: | United States: Federal Government |
|
|
|
|
|
|