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Home > "P" Clinical Trials Conditions > p53 Peptide vaccination for Breast or Ovary Cancer  p53 Peptide vaccination for Breast or Ovary Cancer
p53 Peptide vaccination for Breast or Ovary Cancer
For Condition: Breast Cancer,Breast Neoplasm
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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.
Details: P53 is the most commonly mutated gene in human cancers, it has been found to be mutated in almost 50% of breast and ovarian cancers. Genetic mutation of p53 results in stabilization and increase in the level of the protein. In some cases, overexpression of p53 protein could also occur in tumors without detectable mutation in the open reading frame. Therefore, p53 could function as an antigen through two different mechanisms, as a mutant "foreign" protein and as a self-overexpressed protein. The p53 264 - 272 wild type peptide has been shown to have high affinity for HLA-A2. It has also been shown to be naturally processed and endogenously presented by HLA-A2 in different types of tumor cell lines for CTL recognition. These CTL were able to lyse tumor cells overexpressing wild type or mutant p53 protein and failed to lyse normal cells expressing normal levels of wild type p53. In this protocol we will be vaccinating HLA-A2+ breast or oviania cancer patients who carry tumors which overexpress p53 with the p53 peptide (264 - 272). This peptide will be pulsed on dendritic cells and administered either subcutaneously or intravenously. On either arms the vaccination will be administered along with low dose subcutaneous IL-2. In addition, those patients who express mutant p53 may also be vaccinated with a mutant p53 peptide, which corresponds to the mutation they harbor in their tumor, should the patients progress on the p53:264-272 peptide.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry 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.
Total Enrollment: 45
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Clinical Support Center/NCI 1-888-624-1937
Additional Information:
Study ID Numbers: 990138; 99-C-0138
Study Start Date: July 26, 1999
Record last reviewed: January 1, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001828
Other Breast Cancer Studies:
1. LY353381 in Preventing Breast Cancer in Women With Hyperplasia
2. Morbidity after Diagnosis and Treatment of Breast Cancer Patients
3. Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors
4. Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment
5. Epoetin alfa in Treating Anemia in Patients Who Are Receiving Chemotherapy
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p53 Peptide vaccination for Breast or Ovary Cancer
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