p53 Vaccine for Ovarian Cancer

Stopped early · Phase 2

Conditions studied: Ovarian Neoplasm

In brief

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.

Key facts

Study ID

NCT00001827

Run by

National Cancer Institute (NCI)

People needed

21

Starts

1999-07-26

Expected to finish

2013-01-25

Last updated by the study team

2017-10-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• Any condition that does not fit with the eligibility 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) since these conditions might have an effect on the immune system.
• Pregnant women or nursing mothers are ineligible since the effect of this investigational treatment on the health of the embryo is not known. 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. These patients will be excluded for the possibility of the existence of a different mutation in the other primary malignancy.
• 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.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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