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 @ 2:47 PM
Ignite Modification Date:
2025-12-24 @ 2:47 PM
NCT ID:
NCT00005859
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed intracranial primary malignant glioma
* Glioblastoma multiforme
* Anaplastic astrocytoma\*
* Anaplastic oligodendroglioma\*
* Anaplastic mixed oligodendroglioma\*
* Malignant astrocytoma (not otherwise specified)\* NOTE: \*Closed to accrual effective 5/28/2002
* Progressive or recurrent disease confirmed by MRI or CT scan within the past 14 days
* Stable steroid dose for at least 5-7 days
* Confirmation of true progressive disease by PET scan, thallium scan, MR spectroscopy, or surgery if prior therapy included interstitial brachytherapy or stereotactic radiosurgery
* Failed prior radiotherapy
* Phase I (phase I completed effective 10/2/2001): No more than 2 prior chemotherapy or cytotoxic regimens, including 1 prior adjuvant therapy and 1 prior regimen for progressive or recurrent disease, or 2 prior regimens for progressive disease
* Phase II (phase II open only to patients requiring resection and who provide surgical tissue samples \[effective 3/13/2003\]): No more than 2 prior chemotherapy or cytotoxic regimens for relapsed disease following initial therapy (radiotherapy with or without chemotherapy)
* Prior surgical resection for relapsed disease with no anticancer therapy for up to 12 weeks followed by another surgical resection is considered 1 relapse
* Patients who received prior therapy for a low-grade glioma with a surgical diagnosis of a high-grade glioma are considered to be in first relapse
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* More than 8 weeks
Hematopoietic:
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL (transfusion allowed)
Hepatic:
* Bilirubin no greater than 2.5 times upper limit of normal (ULN)
* SGOT no greater than 2.5 times ULN
Renal:
* Creatinine less than 1.5 mg/dL
Cardiovascular:
* No uncontrolled high blood pressure
* No unstable angina
* No symptomatic congestive heart failure
* No myocardial infarction within the past 6 months
* No serious uncontrolled cardiac arrhythmia
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No severe nonmalignant systemic diseases or active infections
* No other severe concurrent disease that would preclude study therapy
* No allergy to azoles (e.g., ketoconazole, itraconazole, or voriconazole)
* HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 1 week since prior interferon
* No concurrent anticancer immunotherapy
* No concurrent routine prophylactic filgrastim (G-CSF) during first course of study
* No concurrent sargramostim (GM-CSF)
Chemotherapy:
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, suramin, or mitomycin)
* At least 3 weeks since prior procarbazine
* At least 2 weeks since prior vincristine
* No other concurrent anticancer chemotherapy
Endocrine therapy:
* See Disease Characteristics
* At least 1 week since prior tamoxifen
* Concurrent corticosteroids allowed
* No concurrent anticancer hormonal therapy
Radiotherapy:
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy and recovered
* No concurrent anticancer radiotherapy
Surgery:
* See Disease Characteristics
* At least 3 weeks since prior resection and recovered
* Prior recent resection of recurrent or progressive tumor allowed
Other:
* Recovered from all prior therapy (excluding neurotoxicity or alopecia)
* Prior radiosensitizers allowed
* Concurrent H2 blockers and antacids allowed provided taken at least 2 hours before and after tipifarnib
* No concurrent proton pump inhibitors (e.g., omeprazole or lansoprazole)
* No other concurrent medication that would preclude study therapy (e.g., immunosuppressive agents)
* No other concurrent anticancer therapy
* No other concurrent investigational drugs
* No concurrent participation in any other clinical study
* No other concurrent medications except analgesics, chronic treatments for concurrent medical conditions, or agents for life-threatening medical problems
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00005859
Study Brief:
Protocol Section:
NCT00005859