Protocol Number: 99-C-0137

Title:

Vaccine Therapy with Tumor Specific p53 Peptides in Adult Patients with Low Burden Adenocarcinoma of the Ovary

Number:

99-C-0137

Summary:

This study will examine whether vaccination with a p53 peptide can boost an immune response to ovarian cancer and what the side effects are of the vaccine.

Many patients with ovarian cancer have an altered (mutated) gene called p53 that causes the production of abnormal proteins found in their tumor cells. The body's immune system may try, unsuccessfully, to fight these abnormal proteins. In this study, ovarian cancer patients with a p53 abnormality will be vaccinated with a p53 peptide-a part of the same abnormal protein found in their tumor-to try to boost their body's immune response to the cancer.

Patients will be divided into two groups. Group A will have four p53 peptide vaccinations three weeks apart, injected under the skin. The injection will include a drug called ISA-51, which increases the effect of the vaccine. This group will also receive two other drugs that boost the immune system, IL-2 and GM-CSF. Group B will have four p53 peptide vaccinations three weeks apart. The peptide will be mixed with the patient's own blood cells and infused into a vein. This group will also receive IL-2, but not GM-CSF.

All study candidates will be tested to see if their cancer has a p53 abnormality and if their immune system mounted a defense against it. These tests may include a tumor biopsy (removal of a small part of the tumor for microscopic examination); lymphapheresis (a procedure to take blood, remove white blood cells called lymphocytes, and return the red cells); and an immune response test similar to a skin test for tuberculosis. During the study, patients will have additional skin tests and blood tests.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Completed Study; data analyses ongoing

Gender: Female

Referral Letter Required: Yes

Population Exclusion(s): Male

Children

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

Keyword(s):

Immunotherapy

Cancer

Oncogenes

T-cells

Recruitment Keyword(s):

Ovarian Cancer

Condition(s):

Ovarian Neoplasm

Investigational Drug(s):

p53 Peptides

IL-2

Investigational Device(s):

None

Interventions:

Drug: p53 Peptides

Drug: IL-2

Drug: GM-CSF

Supporting Site:

National Cancer Institute

Contact(s):

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.

Citation(s):

A single amino acid interchange yields reciprocal CTL specificities for HIV-i gp 160

Mutations in the p53 gene are frequent in primary resected non small lung cancer

P53 mutations in non-small-lung cancer cell line and their correlation with the presence of ras mutations and clinical features

• 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.

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home

National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 09/16/2008