Ovarian Cancer Clinical Trial
Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
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.
Full 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 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
New York New York, 10021, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.