Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	MSKCC-02122 CELLCONTROL-MSKCC-02122, NCT00058435

Objectives

1. 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.
2. Determine an optimal dose and route of this vaccine for a phase II study.
3. Determine the immune response induced by this vaccination in these patients.
4. Determine the time to development of objective tumor response in patients treated with this regimen.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• At least 3 months

Hematopoietic

• WBC at least 1,500/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

A total of 40 patients (10 patients per cohort) will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Paul Sabbatini, MD, Protocol chair		Ph: 212-639-6423; 800-525-2225

Registry Information
Official Title		Phase I Trial of the Monoclonal Anti-Idiotype Antibody ACA125 in Patients with Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
Trial Start Date		2002-12-17
Registered in ClinicalTrials.gov		NCT00058435
Date Submitted to PDQ		2003-02-28
Information Last Verified		2004-04-26
NCI Grant/Contract Number		CA08748

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