Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004029
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
1999-12-10
Brief Title:
Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A PHASE I TRIAL OF RECOMBINANT VACCINIA VIRUS THAT EXPRESSES PSA IN PATIENTS WITH ADENOCARCINOMA OF THE PROSTATE
Status:
COMPLETED
Status Verified Date:
2006-06
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 I trial to study the effectiveness of vaccine therapy in treating patients with metastatic prostate cancer Vaccines may make the body build an immune response to kill tumor cells
Detailed Description:
OBJECTIVES
I Assess the toxicity associated with repeated vaccination with recombinant vaccinia virus expressing prostate-specific antigen rV-PSA in patients with metastatic adenocarcinoma of the prostate
II Determine the optimal dose of rV-PSA given at monthly intervals based on cellular and hormonal immunity
III Determine whether vaccination with rV-PSA is associated with anti-tumor activity
IV Determine whether granulocyte-macrophage colony-stimulating factor GM-CSF has an effect on cellular and humoral immunity different from rV-PSA and whether the addition of GM-CSF has enhanced antitumor effect compared to rV-PSA alone
OUTLINE This is an open label dose escalation study
Patients in cohorts of 3-6 receive 3 vaccinations with rV-PSA at 4-week intervals days 1 29 57 and 85 in the absence of disease progression or unacceptable toxicity Response assessment is performed at eight weeks Patients who discontinue therapy prior to eight weeks are considered unevaluable for response If dose limiting toxicity is observed in 2 of 6 patients entered at a dose level no further patients are entered at that level and the MTD is defined as the preceding dose level Ten additional patients are treated at the MTD and receive granulocyte-macrophage colony-stimulating factor GM-CSF administered subcutaneously on day -1 through day 2 of each cycle Patients who are HLA-A2 positive have received all 3 rV-PSA vaccinations without unacceptable toxicity and have been off study for at least 30 days due to disease progression may continue treatment with rV-PSA at the highest dose level and the addition of GM-CSF
Patients are followed monthly for 6 months
I Assess the toxicity associated with repeated vaccination with recombinant vaccinia virus expressing prostate-specific antigen rV-PSA in patients with metastatic adenocarcinoma of the prostate
II Determine the optimal dose of rV-PSA given at monthly intervals based on cellular and hormonal immunity
III Determine whether vaccination with rV-PSA is associated with anti-tumor activity
IV Determine whether granulocyte-macrophage colony-stimulating factor GM-CSF has an effect on cellular and humoral immunity different from rV-PSA and whether the addition of GM-CSF has enhanced antitumor effect compared to rV-PSA alone
OUTLINE This is an open label dose escalation study
Patients in cohorts of 3-6 receive 3 vaccinations with rV-PSA at 4-week intervals days 1 29 57 and 85 in the absence of disease progression or unacceptable toxicity Response assessment is performed at eight weeks Patients who discontinue therapy prior to eight weeks are considered unevaluable for response If dose limiting toxicity is observed in 2 of 6 patients entered at a dose level no further patients are entered at that level and the MTD is defined as the preceding dose level Ten additional patients are treated at the MTD and receive granulocyte-macrophage colony-stimulating factor GM-CSF administered subcutaneously on day -1 through day 2 of each cycle Patients who are HLA-A2 positive have received all 3 rV-PSA vaccinations without unacceptable toxicity and have been off study for at least 30 days due to disease progression may continue treatment with rV-PSA at the highest dose level and the addition of GM-CSF
Patients are followed monthly for 6 months
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-T95-0086H | None | None | None |
| DFCI-96079 | None | None | None |