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

NCT ID: NCT00058435

Last Updated: 2013-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-31
• Study Completion Date: 2004-03-31

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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

abagovomab

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Paul Sabbatini, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

CDR0000288831

Identifier Type: REGISTRY

Identifier Source: secondary_id

CELLCONTROL-MSKCC-02122

Identifier Type: -

Identifier Source: secondary_id

02-122

Identifier Type: -

Identifier Source: org_study_id