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

Ovarian Cancer Clinical Trial

Official title:

Phase I Trial of the Monoclonal Anti-Idiotype Antibody ACA125 in Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00058435
• Other study ID #: 02-122
• Secondary ID: CDR0000288831CEL
• Status: Completed
• Phase: Phase 1
• First received: April 7, 2003
• Last updated: June 4, 2013
• Start date: December 2002
• Est. completion date: March 2004

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Biological:
• abagovomab

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,