Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Conditions
Keywords
stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer
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 effectiveness of vaccine therapy in treating patients who have ovarian epithelial, fallopian tube, or peritoneal cancer.
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. * Determine an optimal dose and route of this vaccine for a phase II study. * Determine the immune response induced by this vaccination in these patients. * Determine the time to development of objective tumor response in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 4 treatment arms. * Arm I: Patients receive lower-dose monoclonal antibody ACA125 anti-idiotype vaccine (MOAB ACA125) intramuscularly (IM) on weeks 0, 2, 4, 6, 10, and 14 in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive higher-dose MOAB ACA125 IM as in arm I. * Arm III: Patients receive lower-dose MOAB ACA125 subcutaneously (SC) on weeks 0, 2, 4, 6, 10, and 14 in the absence of disease progression or unacceptable toxicity. * Arm IV: Patients receive higher-dose MOAB ACA125 SC as in arm III. Patients are followed every 6-12 weeks for 2 years. PROJECTED ACCRUAL: A total of 40 patients (10 patients per cohort) will be accrued for this study.
Interventions
BIOLOGICALabagovomab
Sponsors
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Countries
United States
Outcome results
None listed