Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase I Trial of the Monoclonal Anti-Idiotype Antibody ACA125 in Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

Conditions
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Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Intervention / Treatment
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* Biological: abagovomab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: abagovomab|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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