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 @ 4:53 AM
Ignite Modification Date:
2025-12-25 @ 4:53 AM
NCT ID:
NCT00006218
Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed advanced or metastatic malignancy Failed one or more prior standard therapies or considered unlikely to respond to any currently available therapy Measurable or evaluable disease No active, untreated CNS metastases (stable for at least 2 months and no evidence of new CNS metastases)
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Greater than 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL (transfusion allowed) No bleeding disorder (except occult blood for gastrointestinal cancers) Hepatic: Bilirubin no greater than 2.0 mg/dL ALT, AST, and alkaline phosphatase no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN with liver metastases) PT and PTT no greater than 1.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No active heart disease No myocardial infarction within the past 3 months No symptomatic coronary artery disease or heart block No uncontrolled congestive heart failure Pulmonary: No moderate to severe compromise of pulmonary function Other: No active infection No mental deficits and/or psychiatric history that would preclude study No other concurrent life threatening illness Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 18 months after study
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No persistent chronic toxicity from prior chemotherapy greater than grade 1 Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy Concurrent radiotherapy to single site of progressive disease allowed during first course of study treatment Surgery: Not specified Other: At least 3 weeks since any prior treatment for malignancy and recovered No other concurrent investigational drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00006218
Study Brief:
Protocol Section:
NCT00006218