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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Completed

Phase 1

Conditions

Primary Peritoneal Cavity Cancer

Fallopian Tube Cancer

Ovarian Cancer

Treatments

Biological: abagovomab

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00058435

02-122

CELLCONTROL-MSKCC-02122

CDR0000288831 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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