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:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT00055705
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histological confirmation of 1 of the following:
* Ovarian epithelial carcinoma
* Fallopian tube cancer
* Primary peritoneal cancer
* Advanced colorectal carcinoma
* Other malignancy confined to the peritoneal cavity or peritoneal surfaces
* No lesion greater than 2 cm in greatest diameter based on surgical re-assessment
* Low burden of tumor in the abdominal or pelvic cavities and no clinically significant ascites
* Received potentially effective therapy when available (e.g., platinum/taxane for ovarian cancer, fluoropyrimidine-based therapy for colorectal cancer)
* No concurrent hematological malignancy (e.g., chronic lymphocytic leukemia or non-Hodgkin's lymphoma)
* No bilateral adrenal metastases
* No adrenal metastases in the remaining adrenal gland after adrenalectomy (including radical nephrectomy)
* No lung tumors 5 cm or more
* No pleural effusions (at least 25% of hemithorax) by radiography
* No CNS metastases by CT scan or MRI
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 70-100%
Life expectancy
* More than 3 months
Hematopoietic
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin greater than 9 g/dL
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST and ALT no greater than 1.5 times ULN
* Alkaline phosphatase no greater than 1.5 times ULN
* No uncontrolled hepatic dysfunction
* No active hepatitis B or C
Renal
* See Disease Characteristics
* Creatinine no greater than 1.6 mg/dL AND/OR
* Creatinine clearance at least 50 mL/min
* No uncontrolled renal dysfunction
Cardiovascular
* No uncontrolled cardiovascular dysfunction
* No myocardial infarction within the past 6 months
* No life-threatening arrhythmias within the past 6 months
Pulmonary
* See Disease Characteristics
* No uncontrolled pulmonary dysfunction
* No pulmonary atelectasis (lobar)
* No pulmonary infiltrates (lobar)
* No pulmonary consolidation (lobar or segmental)
* No baseline grade II dyspnea
Adrenal
* See Disease Characteristics
* No uncontrolled adrenal dysfunction
* No known adrenal insufficiency
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No uncontrolled gastrointestinal dysfunction
* No neurological dysfunction
* No serious medical or psychological condition that would preclude study participation or increase the risk of adverse effects of the study treatment
* No history of serious immunodeficiency
* No active uncontrolled bacterial infection (including asymptomatic urinary tract infection)
* No contraindication to intraperitoneal therapy including the following:
* Intra-abdominal infection
* Dense widespread adhesions
* Peritonitis
* Periumbilical infection
* Bowel obstruction
* Ileostomy
* No hypersensitivity to eggs
* No continued contact with live birds (e.g., poultry farmers, veterinarians, laboratory technicians, pet store owners, breeders)
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* No more than 3 prior cytotoxic chemotherapy regimens
* More than 30 days since prior chemotherapy
Endocrine therapy
* More than 14 days since prior systemic corticosteroids
Radiotherapy
* More than 30 days since prior radiotherapy
Surgery
* See Disease Characteristics
* No prior complete or partial lobectomy with removal of lung tissue at least segmental size
* No prior organ allograft
Other
* Recovered from prior therapy
* More than 14 days since prior antiviral medication
* More than 4 weeks since prior immunosuppressive drugs
* No other concurrent investigational drugs
* No concurrent chronic immunosuppressive drugs (e.g., cyclosporine)
* No vaccination for influenza within 48 hours of study drug administration
* No concurrent hypoglycemic agents
* No concurrent antiretroviral therapy for HIV-positive patients
* No other concurrent anticancer therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00055705
Study Brief:
Protocol Section:
NCT00055705