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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT00003712
Eligibility Criteria:
DISEASE CHARACTERISTICS:
Part I:
* Histologically proven advanced solid tumors that are refractory or for which no curative therapy exists
* No CNS metastases, peritumoral edema, or symptomatic brain metastases (part I)
* Measurable or evaluable disease
Part II:
* Histologically proven recurrent gliomas or brain metastases for which no curative therapy exists
* Receiving anticonvulsants
* Measurable or evaluable disease
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* At least 3 months
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9 g/dL
Hepatic:
* Bilirubin less than 1.5 mg/dL
* AST or ALT less than 3 times upper limit of normal (ULN) (less than 5 times ULN if liver metastases)
Renal:
* Creatinine less than 2 mg/dL
Cardiovascular:
* No unstable angina
* No myocardial infarction within past 6 months
* No maintenance therapy for life-threatening arrhythmias
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* HIV negative
* No active infection or other serious concurrent illness
* Triglycerides no greater than 300 mg/dL
* Cholesterol no greater than 350 mg/dL
* No known hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, or azithromycin)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas and mitomycin)
* No other concurrent chemotherapy
Endocrine therapy:
* Concurrent corticosteroids used to reduce edema in patients with primary or metastatic CNS tumors allowed
* No concurrent hormonal therapy
Radiotherapy:
* At least 3 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery:
* Not specified
Other:
* At least 1 month since prior investigational agents
* At least 3 weeks since prior immunosuppressive therapy
* No concurrent anticonvulsant therapy (part I)
* No concurrent immunosuppressive therapy (e.g., terfenadine, cisapride, astemizole, pimozide)
* No known agents that inhibit or induce cytochrome p450
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00003712
Study Brief:
Protocol Section:
NCT00003712