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 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT00002594
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of recurrent medulloblastoma or CNS germ cell tumor
* Histologic review of the primary intracranial or spinal cord tumor required
* Biopsy and reduction of tumor bulk prior to study encouraged but not required
* No more than 1 prior primary therapy (radiotherapy or chemoradiotherapy) and/or 1 prior salvage therapy
* Patients with progression on salvage therapy ineligible
* Minimal residual disease (tumor bulk no more than 1.5 cm) or in second clinical complete remission (CR)
* Bone marrow infiltration with or without mass lesions or isolated abnormal CSF cytology as the only manifestation of recurrent disease allowed if a clinical CR is first achieved with conventional therapy
PATIENT CHARACTERISTICS:
Age:
* 2 to 25
Performance status:
* Karnofsky 80-100%
Life expectancy:
* More than 8 weeks
Hematopoietic:
* Absolute neutrophil count greater than 1,000/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic:
* Bilirubin less than 1.5 mg/dL
* SGPT less than 80 IU
Renal:
* Creatinine less than 1.2 mg/dL
Cardiovascular:
* LVEF normal
Other:
* No infection
* Able to tolerate vigorous hydration
* Not pregnant
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* Prior cyclophosphamide or ifosfamide allowed
Endocrine therapy:
* No concurrent dexamethasone as an antiemetic
* Other concurrent corticosteroids allowed
Radiotherapy:
* See Disease Characteristics
* Pretransplantation radiotherapy boost allowed
Surgery:
* See Disease Characteristics
* Pretransplantation surgery allowed
Other:
* At least 4 weeks since prior therapy except corticosteroids
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
25 Years
Study:
NCT00002594
Study Brief:
Protocol Section:
NCT00002594