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 @ 12:58 PM
Ignite Modification Date:
2025-12-24 @ 12:58 PM
NCT ID:
NCT00005061
Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven relapsed or refractory progressive solid tumor that is not amenable to treatment with standard therapies No brain involvement or leptomeningeal disease
PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Postmenopausal Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL No bleeding or clotting abnormalities Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST or ALT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.4 mg/dL Cardiovascular: Normal cardiac function by 12 lead ECG Other: No unstable systemic disease or uncontrolled infection that would preclude study participation No concurrent infection requiring antibiotics Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 70 days after study No psychologic, familial, sociologic, or geographic condition that could preclude compliance HIV negative HTLV-1 negative Hepatitis B surface antigen negative No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix No allergy to protein therapeutics
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: At least 4 weeks since prior hormonal antitumor therapy No concurrent steroids or hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Concurrent radiotherapy allowed Surgery: Greater than 4 weeks since prior surgery except biopsy or fine needle aspiration of tumor masses Other: At least 4 weeks since other prior investigational drugs or therapies No other concurrent anticancer treatments No other concurrent investigational therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00005061
Study Brief:
Protocol Section:
NCT00005061