Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT00058435
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00058435
Study Brief:
Protocol Section:
NCT00058435