A Phase I Study of Recombinant Vaccinia Virus That Expresses Prostate Specific Antigen in Adult Patients With Adenocarcinoma of the Prostate
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 2.65 x 10(5) PFU and 2.65 x 10(6) PFU of vaccine by scarification. Because
higher doses cannot be achieved by scarification, six patients will receive 2.65 x 10(7) PFU
and 2.65 x 10(8) 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.
Interventional
Endpoint Classification: Safety Study, Primary Purpose: Treatment
United States: Federal Government
940118
NCT00001382
March 1994
March 2000
Name | Location |
---|---|
National Cancer Institute (NCI) | Bethesda, Maryland 20892 |