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A Phase I Study of NY-ESO-1 Overlapping Peptides with or without Montanide Vaccination in Patients with Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Second or Third Remission
[Protocol 07-152]
- Full Title :
- A PHASE I STUDY OF NY-ESO-1 OVERLAPPING PEPTIDES (OLP4) WITH OR WITHOUT IMMUNOADJUVANTS MONTANIDE AND POLY-ICLC VACCINATION OF EPITHELIAL OVARIAN CANCER (EOC), FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER PATIENTS IN SECOND OR THIRD REMISSION
- Purpose :
The purpose of this study is to evaluate the effectiveness of a vaccination with a collection of proteins called NY-ESO-1 overlapping peptides in women with ovarian, fallopian tube, or primary peritoneal cancer that is in second or third remission but has a high risk of returning. Some patients will receive the vaccination alone, while others will receive it mixed with an immune stimulant called Montanide. Montanide has been shown to increase the effect of vaccines on the immune system. It is not known whether receiving the vaccine alone or with the Montanide will be more effective.
The NY-ESO-1 protein is only present in the testis and on some cancer cells (including ovarian, fallopian tube, and primary peritoneal cancers). Recent studies have shown that about 45 percent of ovarian tumors have the NY-ESO-1 protein. Because the NY-ESO-1 protein is present on cancer cells but not normal cells, these proteins are good targets for cancer vaccine treatment.
By vaccinating patients who have cancers that might have NY-ESO-1 protein, researchers hope that their immune systems will recognize the protein as abnormal and destroy the cancer cells that have this marker.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have ovarian, fallopian tube, or primary peritoneal cancer that is in second or third remission following initial surgery and chemotherapy which included at least one platinum-based regimen.
- At least 4 weeks must have passed since completion of prior chemotherapy and entry into the study.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Paul Sabbatini at 212-639-6423.
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