Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00058435


Primary Contact:

Study Chair
Paul Sabbatini, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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