Status:
COMPLETED
Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Fallopian Tube Cancer
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Vaccines made from monoclonal antibodies combined with tumor cells may make the body build an immune response to kill tumor cells. PURPOSE: Randomized phase I trial to study the effectiven...
Detailed Description
OBJECTIVES: * Determine the safety of varying routes and doses of monoclonal antibody ACA125 anti-idiotype vaccine in patients with ovarian epithelial, fallopian tube, or peritoneal cancer. * Determi...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed ovarian epithelial, fallopian tube, or peritoneal cancer
- Stage II-IV
- Initially treated with surgery and at least 1 platinum-based chemotherapy regimen
- Must have relapsed after initial treatment and completed chemotherapy for recurrent disease
- Asymptomatic residual measurable disease on CT scan and/or an elevated CA 125 allowed
- Complete clinical remission allowed, defined by the following criteria:
- CA 125 no greater than 35 IU/mL
- No objective evidence of disease by CT scan
- Normal physical examination
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Karnofsky 70-100%
- Life expectancy
- At least 3 months
- Hematopoietic
- WBC at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- Hemoglobin at least 10 g/dL
- Hepatic
- Bilirubin no greater than 2 times normal
- ALT no greater than 2 times normal
- Alkaline phosphatase no greater than 2 times normal
- Renal
- Creatinine no greater than 1.5 times normal
- Other
- Not pregnant or nursing
- No potential for child bearing
- Human antimurine antibody negative
- HIV negative
- No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No active infection
- No known autoimmune disease (e.g., rheumatoid arthritis or ulcerative colitis)
- No known immune deficiency (e.g., hypogammaglobulinemia)
- No known allergy to murine proteins
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- At least 6 weeks since prior interferon
- At least 6 weeks since prior immunotherapy or biological response modifiers
- No prior anticancer vaccine
- Chemotherapy
- See Disease Characteristics
- At least 3 weeks since prior cytotoxic or investigational chemotherapy
- Endocrine therapy
- No concurrent steroids
- Radiotherapy
- At least 4 weeks since prior radiotherapy
- Surgery
- See Disease Characteristics
- Other
- At least 1 week since prior antibiotics
- No concurrent cyclosporine
- No other concurrent immunosuppressive therapy
Exclusion
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
End Date :
March 1 2004
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00058435
Start Date
December 1 2002
End Date
March 1 2004
Last Update
June 5 2013
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021