Vaccine Therapy in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer
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|ClinicalTrials.gov Identifier: NCT00006041|
Recruitment Status : Completed
First Posted : June 28, 2004
Last Update Posted : June 19, 2013
RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill the tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have ovarian, fallopian tube, or peritoneal cancer.
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer||Biological: MUC1-KLH conjugate vaccine Biological: MUC1-KLH vaccine/QS21 Biological: QS21||Phase 1|
OBJECTIVES: I. Determine the safety of immunization with glycosylated MUC-1-KLH vaccine plus adjuvant QS21 in patients with ovarian, fallopian tube, or peritoneal epithelial cancer. II. Determine the dose of this treatment regimen for optimal antibody response in these patients. III. Determine the effect of immunization with this treatment regimen on the T-cell response in these patients.
OUTLINE: This is a dose escalation study of glycosylated MUC-1-KLH vaccine. Patients receive glycosylated MUC-1-KLH vaccine and QS21 subcutaneously once a week on weeks 1-3, 7, and 19. Cohorts of 6 patients receive escalating doses of glycosylated MUC-1-KLH until the dose for optimal antibody response without unacceptable toxicity is determined. Patients are followed at 2 and 12 weeks, and then every 3 months thereafter as long as detectable immunity against MUC-1 persists.
PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Vaccination of Patients Who Have Ovarian, Fallopian Tube or Peritoneal Cancer With Glycosylated MUC-1-KLH Conjugate Plus the Immunological Adjuvant QS-21|
|Study Start Date :||February 2000|
|Actual Primary Completion Date :||February 2002|
|Actual Study Completion Date :||February 2002|
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): NCT00006041
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Paul Sabbatini, MD||Memorial Sloan Kettering Cancer Center|