Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001382
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Phase I Study of Recombinant Vaccinia Virus That Expresses Prostate Specific Antigen in Adult Patients With Adenocarcinoma of the Prostate
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Study of Recombinant Vaccinia Virus That Expresses Prostate Specific Antigen in Adult Patients With Adenocarcinoma of the Prostate
Status:
COMPLETED
Status Verified Date:
2000-03
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:
This trial will evaluate in patients with metastatic prostate cancer the tolerability toxicities efficacy and immunologic effects of repeated vaccinations with a recombinant vaccinia virus that contains the Prostate Specific Antigen gene PROSTVAC
Detailed Description:
This trial will evaluate in patients with metastatic prostate cancer the tolerability toxicities efficacy and immunologic effects of repeated vaccinations with a recombinant vaccinia virus that contains the Prostate Specific Antigen gene PROSTVAC Patients with PSA-expressing adenocarcinoma of the prostate will be evaluated for eligibility that includes a history of prior vaccinia as vaccine against smallpox and immunocompetence We completed a phase I trial investigating the use of rV-CEA in adenocarcinomas of the GI tract lung and breast The toxicities encountered are local reactions to the vaccine We did not encounter any myelosuppression or systemic autoimmune reaction We would like to evaluate four doses to ensure safety and to decide a best biological dose Six patients will receive 265 x 105 PFU and 265 x 106 PFU of vaccine by scarification Because higher doses cannot be achieved by scarification six patients will receive 265 x 107 PFU and 265 x 108 PFU subcutaneously We plan to give three vaccinations at four week intervals All six patients treated in each dose level must be evaluable for 4 weeks before enrolling patients at the higher dose level No intrapatient escalation is planned Toxicity tumor response and humoral and cellular immunity factors will be monitored Optional lymphapheresis will be done on patients that are HLA A2 Once we determined the best biological dose we would like to accrue an additional 6 patients to that level
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 |
|---|---|---|---|
| 94-C-0118 | None | None | None |