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 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 12:08 AM
NCT ID:
NCT00025558
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of one of the following malignant brain tumors:
* Anaplastic astrocytoma
* Glioblastoma multiforme
* Anaplastic oligodendroglioma
* Medulloblastoma
* High-grade ependymoma
* Germ cell tumors
* Pineoblastoma
* Other primitive neuroectodermal tumors
* Recurrent disease or resistant to conventional therapy (e.g., surgery, radiotherapy, or standard chemotherapy)
* No prior myeloablative doses of thiotepa OR
* Newly diagnosed malignant glioma with minimal residual disease after prior radiotherapy
* Minimal residual disease is defined as tumor with maximum diameter of less than 1.5 cm by MRI and no corticosteroid dependency
PATIENT CHARACTERISTICS:
Age:
* Over 1 to under 50
Performance status:
* Karnofsky 70-100% OR
* Lansky 70-100%
Life expectancy:
* More than 12 weeks
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm3
* Platelet count at least 100,000/mm3
* Hemoglobin at least 10 g/dL (transfusion allowed)
Hepatic:
* Bilirubin less than 1.5 times upper limit of normal (ULN)
* SGOT/SGPT less than 2.5 times ULN
* Alkaline phosphatase less than 2.5 times ULN
Renal:
* Creatinine less than 1.5 times ULN
* Creatinine clearance at least 70 mL/min
* BUN less than 1.5 times ULN
Cardiovascular:
* Ejection fraction greater than 50% OR
* Shortening fraction greater than 27%
* No evidence of myocardial ischemia on EKG if over 40 years of age
Other:
* HIV negative
* No AIDS-related illness
* No frequent vomiting or medical condition that would preclude oral medication (e.g., partial bowel obstruction)
* No other malignancy within the past 2 years except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 2 weeks since prior biologic therapy or immunotherapy
Chemotherapy:
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
Endocrine therapy:
* See Disease Characteristics
Radiotherapy:
* See Disease Characteristics
* At least 6 weeks since prior radiotherapy and recovered
* At least 6 weeks since prior brachytherapy or radiosurgery
Surgery:
* See Disease Characteristics
* Recovered from prior major surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
49 Years
Study:
NCT00025558
Study Brief:
Protocol Section:
NCT00025558