NIH Clinical Research Studies

Protocol Number: 99-C-0138

Active Accrual, Protocols Recruiting New Patients

Title:
Vaccine Therapy with Tumor Specific p53 Peptides in Adult Patients with Adenocarcinoma of the Breast or Ovary
Number:
99-C-0138
Summary:
This study will examine whether vaccination with a p53 peptide can boost an immune response to breast or ovarian cancer and what the side effects are of the vaccine.

Many breast and ovarian cancer patients 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, breast 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: Active Accrual Of New Subjects
Gender: Female
Referral Letter Required: Yes
Population Exclusion(s): Male

Eligibility Criteria:
INCLUSION CRITERIA:

Patients must be 18 years of age or older.

Histologic diagnosis of adenocarcinoma of the breast or ovary.

Tumor tissue availability for determination of p53 protein expression and genetic mutation (paraffin block, or fresh tissue).

Immunohistochemical analysis of the tumor must demonstrate positive p53 staining.

Patients should have stage IV, recurrent or progressive disease with no further chemotherapy or radiation options, which are known to increase survival, are available.

ECOG performance status of 1 or 0.

Expected survival of more than 3 months.

The patients should not have received chemotherapy, radiation therapy, immunotherapy or systemic doses of steroids for at least 4 weeks prior to starting vaccination. And the patients should have recovered from all acute toxicities of previous treatment. Patients who received bone marrow transplantation within a year will not be eligible for the trial.

Patients must understand and sign an informed consent document that explains the neoplastic nature of his/her disease, the procedures to be followed, the experimental nature of the treatment, alternative treatments, and potential risks and toxicities.

Patients should have HLA-A2.1 haplotype.

EXCLUSION CRITERIA:

Any condition that does not fit the inclusion criteria.

Any of the following: Platelets less than 100K/mm(3); Creatinine greater than 2.0 mg/dl; Serum Bilirubin greater than 2.0 mg/dl, SGOT, or SGPT greater than 4 times normal.

HIV or hepatitis B or C (i.e., detectable HBS Antigen or HC Ab).

Pregnant women or nursing mothers are ineligible. Women with reproductive potential must have negative pregnancy test and must use adequate contraception.

Patients with active ischemic heart disease (i.e., Class III or IV cardiac disease-New York Heart Association), a recent history of myocardial infarction (within the last 6 months), History of congestive heart failure, ventricular arrythmias or other arrythmias requiring therapy.

Second malignancy (within the past 2 years) other than curatively treated carcinoma in-situ of cervix or basal cell carcinoma of the skin.

History of CNS metastases.

Patients with underlying immune deficiency or history of autoimmune disease e.g. (autoimmune neutropenia, thrombocytopenia, or hemolytic anemia; systemic lupus erythematosus, Sjogren syndrome, or scleroderma; myasthenia gravis; Goodpasture syndrome; Addison's disease, Hashimoto's thyroiditis, active Graves' disease, or other diseases which qualify as autoimmune in origin).

Patients with active infections requiring antibiotics. Patients requiring chronic suppressive antibiotics will be eligible for the trial.

If, in the opinion of the principal or associate investigators, it is not in the best medical interest of the patient to enter this study, the patient will be ineligible.

Special Instructions: Currently Not Provided
Keywords:
Immunotherapy
Cancer
Oncogenes
T Cells
Recruitment Keywords:
Breast Cancer
Conditions:
Breast Cancer
Breast Neoplasm
Investigational Drug(s):
p53 Peptides
IL-2
Investigational Device(s):
None

Contacts:
CSSC
Clinical Studies Support Center/NCI
164 Rollins Avenue
2nd FLoor
Rockville, MD 20852
Phone: (888) 624-1937
Fax: (301) 881-8239
Electronic Address: ncicssc@mail.nih.gov

Citations:
Mutation in the p53 gene are frequent in primary resected non small lung cancer

p53 mutation in non small lung cancer cell line and their correlation with the presence of ras mutations and clinical features

Immunohistochemical analysis of p53 and HER-2/neu proteins in human tumors

Active Accrual, Protocols Recruiting New Patients

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