Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by:
Memorial Sloan-Kettering Cancer Center Identifier:
First received: April 7, 2003
Last updated: June 4, 2013
Last verified: June 2013

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.

Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Biological: abagovomab
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial of the Monoclonal Anti-Idiotype Antibody ACA125 in Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

Resource links provided by NLM:

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Study Start Date: December 2002
Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • At least 3 months


  • WBC at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL


  • Bilirubin no greater than 2 times normal
  • ALT no greater than 2 times normal
  • Alkaline phosphatase no greater than 2 times normal


  • Creatinine no greater than 1.5 times normal


  • 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


Biologic therapy

  • At least 6 weeks since prior interferon
  • At least 6 weeks since prior immunotherapy or biological response modifiers
  • No prior anticancer vaccine


  • See Disease Characteristics
  • At least 3 weeks since prior cytotoxic or investigational chemotherapy

Endocrine therapy

  • No concurrent steroids


  • At least 4 weeks since prior radiotherapy


  • See Disease Characteristics


  • At least 1 week since prior antibiotics
  • No concurrent cyclosporine
  • No other concurrent immunosuppressive therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00058435

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Study Chair: Paul Sabbatini, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided Identifier: NCT00058435     History of Changes
Other Study ID Numbers: 02-122, CDR0000288831, CELLCONTROL-MSKCC-02122
Study First Received: April 7, 2003
Last Updated: June 4, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
fallopian tube cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms processed this record on November 25, 2014