monoclonal antibody vaccine therapy in treating patients with ovarian epithelial, fallopian tube, or peritoneal cancer

Conditions: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

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.

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.

Eligibility 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

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