Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
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|ClinicalTrials.gov Identifier: NCT00066729|
Recruitment Status : Completed
First Posted : August 7, 2003
Last Update Posted : April 26, 2011
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: This phase I trial to studying the side effects of vaccine therapy in treating patients with ovarian epithelial, primary peritoneal, or fallopian tube cancer.
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer||Biological: NY-ESO-1 peptide vaccine Biological: incomplete Freund's adjuvant||Phase 1|
- Determine the safety of NY-ESO-1b peptide vaccine and Montanide ISA-51 in patients with ovarian epithelial, primary peritoneal, or fallopian tube cancer expressing NY-ESO-1 or LAGE-1.
- Determine the immunologic profile (NY-ESO-1 antibody, CD8+ cells, and delayed-type hypersensitivity) induced by this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive NY-ESO-1b peptide vaccine emulsified with Montanide ISA-51 subcutaneously once every 3 weeks on weeks 1, 4, 7, 10, and 13 in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 weeks and then every 6-12 weeks for 2 years or until disease progression.
PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study Of NY-ESO-1b Peptide Plus Montanide ISA-51 In Patients With Ovarian, Primary Peritoneal, Or Fallopian Tube Cancer Expressing NY-ESO-1 or LAGE-1|
|Study Start Date :||May 2003|
|Actual Primary Completion Date :||July 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00066729
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Jakob Dupont, MD||Memorial Sloan Kettering Cancer Center|