Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005947
Status:
COMPLETED
Last Update Posted:
2010-11-01
First Post:
2000-07-05
Brief Title:
Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Sponsor:
Dendreon
Organization:
Dendreon
Study Overview
Official Title:
A Randomized Double Blind Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells Provenge for Asymptomatic Metastatic Hormome-Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2010-10
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:
Rationale Vaccines may make the body build an immune response to kill tumor cells It is not yet known if vaccine therapy is effective for prostate cancer
Purpose Randomized phase III trial to determine the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy
Purpose Randomized phase III trial to determine the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy
Detailed Description:
Objectives
I Compare the time to progression time to development of disease-related pain and incidence of grade 3 or worse treatment-related adverse events in patients with asymptomatic metastatic hormone refractory adenocarcinoma of the prostate treated with APC8015 versus control infusion II Compare response rate and duration of response in these patients
Outline This is a randomized study Patients are randomized to one of two treatment arms Arm I Autologous dendritic cell precursors ADCP are harvested on weeks 0 2 and 4 Patients receive APC8015 comprised of ADCP activated with prostatic acid phosphatase-sargramostim GM-CSF fusion protein IV over 30 minutes beginning 2 days after each harvest for a total of 3 infusions Arm II ADCP are harvested as in arm I Patients receive unactivated ADCP IV over 30 minutes beginning 2 days after each harvest for a total of 3 infusions Pain is assessed weekly for up to 3 years or until 4 weeks after objective disease progression Patients are followed monthly for up to 3 years or until disease progression At the time of disease progression patients treated on arm II may receive treatment on Protocol D9903
Projected Accrual A total of 120 patients 80 in arm I and 40 in arm II will be accrued for this study
I Compare the time to progression time to development of disease-related pain and incidence of grade 3 or worse treatment-related adverse events in patients with asymptomatic metastatic hormone refractory adenocarcinoma of the prostate treated with APC8015 versus control infusion II Compare response rate and duration of response in these patients
Outline This is a randomized study Patients are randomized to one of two treatment arms Arm I Autologous dendritic cell precursors ADCP are harvested on weeks 0 2 and 4 Patients receive APC8015 comprised of ADCP activated with prostatic acid phosphatase-sargramostim GM-CSF fusion protein IV over 30 minutes beginning 2 days after each harvest for a total of 3 infusions Arm II ADCP are harvested as in arm I Patients receive unactivated ADCP IV over 30 minutes beginning 2 days after each harvest for a total of 3 infusions Pain is assessed weekly for up to 3 years or until 4 weeks after objective disease progression Patients are followed monthly for up to 3 years or until disease progression At the time of disease progression patients treated on arm II may receive treatment on Protocol D9903
Projected Accrual A total of 120 patients 80 in arm I and 40 in arm II will be accrued for this study
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 |
|---|---|---|---|
| NCI-G00-1789 | None | None | None |
| DEN-D9901 | None | None | None |