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

Sponsor:	Memorial Sloan-Kettering Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00058435

Purpose

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 I

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:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Abagovomab

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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

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.

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00058435

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Paul Sabbatini, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00058435 History of Changes
Other Study ID Numbers:	CDR0000288831, MSKCC-02122, CELLCONTROL-MSKCC-02122
Study First Received:	April 7, 2003
Last Updated:	April 23, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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:

Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female

Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases

ClinicalTrials.gov processed this record on February 12, 2012