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 @ 2:38 PM
Ignite Modification Date:
2025-12-24 @ 2:38 PM
NCT ID:
NCT00002759
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Malignant solid tumor or lymphoma refractory to standard therapy or for which no therapy of proven benefit exists
* No leukemia
* Measurable or evaluable disease
PATIENT CHARACTERISTICS:
* Age: 18 and over
* Performance status: Karnofsky 70-100%
* Life expectancy: At least 3 months
* WBC at least 3,500/mm3
* Absolute neutrophil count at least 1,500/mm3
* Platelet count at least 100,000/mm3
* Hemoglobin at least 9 g/dL
* Bilirubin no greater than 1.5 mg/dL
* AST/ALT less than twice normal (unless due to disease)
* PT and PTT normal
* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance at least 60 mL/min
* No history of congestive heart failure requiring medical therapy
* No clinically significant or life threatening cardiac arrhythmia
* No history of significant pulmonary disease or lymphangitic lung disease
* No hypersensitivity to cyclosporine or cremophore
* No history of manifest or latent porphyria or hypersensitivity to barbiturates (for parts of study using phenobarbital)
* No history of inflammatory bowel disease requiring therapy
* No chronic diarrhea syndrome or paralytic ileus
* No medical or psychiatric condition that precludes informed consent
* Not pregnant
* Effective contraception required of fertile women
PRIOR CONCURRENT THERAPY:
* At least 4 weeks since prior biologic therapy
* At least 2 weeks since prior colony stimulating factors
* At least 4 weeks since prior chemotherapy (at least 6 weeks since nitrosoureas or mitomycin)
* No prior bleomycin or irinotecan
* At least 4 weeks since prior radiotherapy to greater than 25% of bone marrow
* Minimum time interval between prior therapy and eligibility shortened by 2 weeks when phenobarbital is administered
* Concurrent use of medications that affect the central nervous or cardiovascular systems (e.g., anticonvulsants, calcium channel blockers, oral contraceptives) must be approved by the Principal Investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00002759
Study Brief:
Protocol Section:
NCT00002759