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

Brief Title

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

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Phase IIB Study of the Safety and Efficacy of OVAREX MabB43.13 in Ovarian Cancer Patients With an Elevated Serum CA 125 But Without Other Evidence of Disease

Brief Summary

      RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver
      tumor-killing substances to them without harming normal cells.

      PURPOSE: Randomized phase II trial to study the effectiveness of monoclonal antibody therapy
      in treating patients who have ovarian, fallopian tube, or peritoneal cancer.

Detailed Description

      OBJECTIVES: I. Determine the safety of OvaRex monoclonal antibody B43.13 in patients with
      elevated CA 125 and histologically proven epithelial adenocarcinoma of the ovary, fallopian
      tube, or peritoneum, but without other evidence of disease. II. Determine the time to disease
      progression, overall survival, CA 125 levels, immune responses, and quality of life of these
      patients treated with this regimen.

      OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment
      arms: Arm I: Patients receive placebo IV during weeks 1, 3, 5, 9, 13, 25, 37, and 49. Arm II:
      Patients receive OvaRex monoclonal antibody B43.13 (MOAB B43.13) IV during weeks 1, 3, 5, 9,
      13, 25, 37, and 49. Patients in either treatment arm who have no disease progression after
      week 49 receive MOAB B43.13 once every 12 weeks until week 121. Patients with disease
      progression after week 49 may receive MOAB B43.13 alone, in combination with, or following
      chemotherapy. Quality of life is assessed during the study.

      PROJECTED ACCRUAL: A total of 102 patients will be accrued for this study.

Study Phase

Phase 2

Study Type

Interventional

Condition

Fallopian Tube Cancer

Intervention

oregovomab

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

Start Date

November 1998

Eligibility Criteria

        DISEASE CHARACTERISTICS: Histologically proven epithelial adenocarcinoma of the ovary,
        fallopian tube, or peritoneum CA 125 greater than 35 U/mL No conclusive radiological or
        clinical evidence of disease No disease recurrence Must have received only 1 prior platinum
        based chemotherapy regimen No tumors of low malignant potential or noninvasive disease

        PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
        least 6 months Hematopoietic: Hemoglobin at least 8.0 g/dL Lymphocyte count at least
        1,000/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic:
        Bilirubin no greater than 1.5 times normal Renal: Creatinine no greater than 2 mg/dL
        Cardiovascular: No uncontrolled hypertension No congestive heart failure No arrhythmias
        Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
        contraception No active autoimmune disease requiring chronic treatment No allergy to murine
        proteins No documented anaphylactic reaction to any drug No active infection causing fever
        No immunodeficiency disease No uncontrolled nonmalignant diseases No other malignancy
        (except nonmelanomatous skin cancer or carcinoma in situ of the cervix) unless curatively
        treated and free of disease for at least 5 years

        PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine monoclonal antibodies
        Chemotherapy: See Disease Characteristics At least 4 weeks since prior platinum based
        chemotherapy No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At
        least 6 months since prior limited field (i.e., abdominal or pelvic) radiotherapy No prior
        whole abdominal radiotherapy Surgery: At least 4 weeks since prior surgery No prior
        splenectomy Other: At least 4 weeks since prior immunosuppressive drugs No concurrent
        immunosuppressive drugs At least 30 days since other prior investigational drugs

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Michael A. Bookman, MD, ,

Location Countries

Canada

Location Countries

Canada

Administrative Informations

NCT ID

NCT00004064

Organization ID

CDR0000067265

Secondary IDs

ALTAREX-OVA-Gy-10

Study Sponsor

AltaRex

Study Sponsor

Michael A. Bookman, MD, Study Chair, Fox Chase Cancer Center

Verification Date

June 2007