Protocol Number: 02-C-0218

Title:

A Pilot Trial of Pox Vector PSA Vaccine With Concurrent Docetaxel Vs. Pox Vector PSA Vaccine Followed By Docetaxel In Metastatic Androgen Independent Prostate Cancer

Number:

02-C-0218

Summary:

This study will compare the effectiveness of an experimental vaccine alone or vaccine with the anti-cancer drug docetaxel in treating prostate cancer. Docetaxel is an approved treatment for breast, lung, and other cancers. The experimental vaccine is composed of four parts as follows: rV-PSA - vaccinia virus plus human DNA that produces PSA (prostate specific antigen); rV-B7.1 - vaccinia virus plus human DNA that produces B7.1 (a protein that helps guide immune cells to their targets); rF-PSA - fowlpox virus plus human DNA that produces PSA; and GM-CSF and IL-2 - drugs that boost the immune system.

Patients 18 years of age and older who 1) have advanced prostate cancer that has not responded to hormonal therapy, 2) have been vaccinated against smallpox, 3) do not have a history of allergy to eggs or egg products, and 4) are HLA-A2+ may be eligible for this study. Patients must have a rising PSA level and evidence of tumor spread to other parts of the body. Candidates will be screened with blood tests, a bone scan, and X-rays or other imaging tests, such as CT and MRI scans. Participants will be randomly assigned to one of the following treatment groups:

Vaccination Alone

Patients in this group will receive the vaccine in 4-week treatment cycles, delivered as follows: rV-PSA and rV-B7.1 are mixed and given together as one injection on day 1 only; rF-PSA is initially given on day 15 and then, beginning day 29, once every 4 weeks; GM-CSF is given for 4 days beginning on day 1 with the rV-PSA and rV-B7.1 and on day 15 with the rF-PSA vaccinations, and then at the beginning of the cycle as long as the vaccinations continue. The vaccinations are injected under the skin of the upper arm. Treatment with rF-PSA only will continue every 4 weeks indefinitely as long as the cancer is controlled and there are no serious side effects. If there is evidence of disease progression or rising PSA levels after the first 3 months on vaccine, patients in this group may receive docetaxel.

Vaccination with Docetaxel

In addition to the vaccine, patients in this group will receive docetaxel. The drug will be infused through a vein over 30 minutes for 3 consecutive weeks out of every 4 weeks. Treatment starts on day 29. In addition, patients in this group will take dexamethasone 12 hours and 1 hour before and 12 hours after the docetaxel to help prevent fluid retention (edema) the drug may cause. If there is evidence of disease progression or rising PSA levels after the first 3 months on docetaxel, patients in this group will be taken off the study.

Response to treatment will be evaluated periodically with scans and X-rays.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Follow-up Of Previously Enrolled Subjects Only

Gender: Male

Referral Letter Required: No

Population Exclusion(s): Female

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions: Currently Not Provided

Disease Category:

PROTICD

Keywords:

Randomized

Hormone-Refractory

Chemotherapy

Immune

Cancer

Recruitment Keywords:

Prostate Cancer

AIPC

Androgen Independent Prostate Cancer

Conditions:

Prostatic Neoplasms

Investigational Drug(s):

Recombinant Fowlpox-PSA

Recombinant Vaccinia-PSA

Recombinant Vaccinia-B7.1

Investigational Device(s):

None

Contacts:

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citations:

Eisenberger MA, Abrams JS Chemotherapy for prostatic carcinoma Semin Urol 1988 Nov;6(4):303-10 Review No abstract available PMID: 3068768

Yagoda A, Petrylak D, Thompson S Cytotoxic chemotherapy for advanced renal cell carcinoma Urol Clin North Am 1993 May;20(2):303-21 Review PMID: 8493752

Kantoff PWHydrocortisone with or without mitoxantrone in men with hormone-refractoryprostate cancer: results of the cancer and leukemia group B 9182 study J Clin Oncol 1999 Aug;17(8):2506-13 PMID: 10561316

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Bethesda, Maryland 20892. Last update: 10/15/2004