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 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT00004059
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy exists
* Measurable or evaluable disease
* No CNS metastasis or primary CNS malignancy
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* Not specified
Hematopoietic:
* WBC greater than 3,500/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* SGOT and SGPT no greater than 2.5 times upper limit of normal
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance greater than 60 mL/min
Cardiovascular:
* No history of coronary artery disease documented by prior myocardial infarction, angiography, or coronary-artery bypass grafting
* No cardiac arrhythmias or congestive heart failure within the past 6 months
* Stable atrial fibrillation on standard treatment allowed at discretion of investigator
Pulmonary:
* DLCO at least 60% of predicted
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 2 months after study
* No active serious or uncontrolled infection
* HIV negative
* No diabetes
* No other medical condition that would preclude study
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
Biologic therapy:
* At least 4 weeks since prior immunotherapy and recovered
Chemotherapy:
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered
* Prior fluorouracil allowed
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior mediastinal radiotherapy
* At least 4 weeks since prior radiotherapy and recovered
Surgery:
* Not specified
Other:
* No concurrent anticonvulsant medications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00004059
Study Brief:
Protocol Section:
NCT00004059