Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027599
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2001-12-07
Brief Title:
APC8015 and Bevacizumab in Treating Patients With Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2003-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase II trial to study the effectiveness of APC8015 combined with bevacizumab in treating patients who have undergone radiation therapy andor 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCSF-0155-01 | None | None | None |
| NCI-2617 | None | None | None |
| UCSF-01554 | None | None | None |
| CDR0000069047 | REGISTRY | PDQ Physician Data Query | None |