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

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
abagovomab
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 7, 2003
Last Updated
June 4, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00058435
Brief Title
Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
Official Title
Phase I Trial of the Monoclonal Anti-Idiotype Antibody ACA125 in Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
March 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
abagovomab

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Sabbatini, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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