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
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.
Study Phase
Phase 1
Study Type
Interventional
Condition
Fallopian Tube Cancer
Intervention
abagovomab
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Start Date
December 2002
Completion Date
March 2004
Primary Completion Date
March 2004
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Paul Sabbatini, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00058435
Organization ID
02-122
Secondary IDs
CDR0000288831
Study Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Paul Sabbatini, MD, Study Chair, Memorial Sloan Kettering Cancer Center
Verification Date
June 2013