Vaccine Therapy in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer
NCT ID: NCT00006041
Last Updated: 2013-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
2000-02-29
2002-02-28
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have ovarian, fallopian tube, or peritoneal cancer.
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Detailed Description
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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.
Conditions
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Study Design
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TREATMENT
Interventions
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MUC1-KLH conjugate vaccine
MUC1-KLH vaccine/QS21
QS21
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin, SGOT, and alkaline phosphatase less than 2 times normal Renal: Creatinine less than 1.6 mg/dL Creatinine clearance at least 50 mL/min Other: No other concurrent active invasive malignancy No seafood allergy No positive stool guaiac (excluding hemorrhoids)
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Memorial Sloan Kettering Cancer Center
OTHER
Principal Investigators
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Paul Sabbatini, MD
Role: STUDY_CHAIR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Countries
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Other Identifiers
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CDR0000068056
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-H00-0060
Identifier Type: -
Identifier Source: secondary_id
99-121
Identifier Type: -
Identifier Source: org_study_id
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