Protocol Number: 95-C-0154

Title:

Vaccine Therapy and Detection of Immunologic Responses with Human Papillomavirus 16 E6 and E7 Peptides in Patients with Metastatic or Locally Advanced Cervical Cancer and Other Cancers Carrying the HPV

Number:

95-C-0154

Summary:

Group A: Patients have cervical cancer stage IV, recurrent disease, or stage III disease that did not receive appropriate radiation therapy, and patients with other advanced tumors which harbor HPV such as anogenital, esophageal or head and neck cancers. A total of 12 patients will be accrued, 6 patients receive vaccination with HPV16 E6 and the other 6 receive HPV16 E7 peptides.

Group B: Patients have stage III cervical carcinomas that have been treated with standard therapy with no evidence of residual disease. Vaccination in this group is given as an adjuvant therapy. A total of 12 patients will be accrued, 6 patients receive vaccination with HPV16 E6 and the other 6 receive HPV16 E7 peptides.

Patients in Group A and Group B are assigned to either E6 or E7 by the Principal Investigator.

The following acronyms are used:

APC Antigen-Presenting Cells

HPV16 Human Papillomavirus 16

PBMC Peripheral Blood Mononuclear Cells

Vaccine Therapy. Vaccination with autologous APC (PBMC pulsed in vitro with HPV16 E6 or E7 peptide).

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Follow-up Of Previously Enrolled Subjects Only

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Male

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:

Many protocols are potentially hazardous, are intended only for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this protocol should be consulted before using this protocol. Dose and schedule modifications are required for patients who develop gastrointestinal, hematologic, neurologic, and biochemical (renal, hepatic, etc.) and/or other abnormalities after the administration of therapy. Additionally, Federal regulations for the protection of human subjects require approval of clinical trials by your local Institutional Review Board.

Disease Category:

PROTICD

Keywords:

Immunotherapy

Stage IV

Stage III

Recurrent Disease

Vaccine

Recruitment Keywords:

None

Conditions:

Anus Neoplasm

Cervix Neoplasm

Esophageal Neoplasm

Head and Neck Neoplasm

Papovaviridae Infection

Investigational Drug(s):

E6 peptides

E7 peptides

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:

Epstein-Barr virus strategy in normal and neoplastic B cells

Mammalian hepatitis B viruses and primary liver cancer

Human T-cell lymphoma/leukemia retroviruses and malignancy

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/16/2004