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 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT00074334
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed supratentorial malignant glioma
* Recurrent or progressive disease
* Amenable to gross total resection, clinically indicated partial resection, or biopsy
* Tumor must have a single solid portion at least 1 cm and no greater than 5 cm in maximum diameter
* No tumor crossing midline
* Tumors invading the corpus callosum that do not extend beyond to midline or into the contralateral hemisphere allowed
* No more than 1 focus of tumor
* No tumors involving the brainstem or cerebellum
* No tumor dissemination (i.e., subependymal or leptomeningeal)
* Must be on steroids ≥ 3 days prior to surgery
* Must have received prior external beam radiotherapy (tumor dose at least 45 Gy) and completed therapy at least 8 weeks before study entry
* No impending herniation, including midline shift greater than 0.5 cm
* No requirement for immediate palliative treatment
PATIENT CHARACTERISTICS:
Age
* 3 to 21
Performance status
* Karnofsky 60-100% (patients over 16 years of age) OR
* Lansky 60-100% (patients age 16 and under)
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3\*
* Hemoglobin at least 9 g/dL\* NOTE: \*Transfusion independent
Hepatic
* ALT and AST less than 2.5 times upper limit of normal (ULN)
* PT and PTT no greater than ULN
Renal
* Creatinine less than 1.5 times normal OR
* Glomerular filtration rate greater than 70 mL/min
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 30 days after study participation
* No uncontrolled seizures
* No active infection requiring treatment
* No unexplained febrile illness
* No known or suspected allergies to local anesthetics
* No systemic disease or other condition that may be associated with unacceptable anesthetic/operative risk and/or that would preclude study completion
* No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 8 weeks since prior hematopoietic stem cell transplantation
Chemotherapy
* At least 6 months since prior polifeprosan 20 with carmustine implant (Gliadel® wafer)
* At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas and 2 weeks for vincristine)
* At least 2 weeks since prior non-cytotoxic chemotherapy
* No other prior intracerebral chemotherapy
* No concurrent chemotherapy
Endocrine therapy
* Concurrent steroids allowed
Radiotherapy
* See Disease Characteristics
* No prior focal radiotherapy (e.g., gamma knife radiosurgery, stereotactic radiosurgery, or brachytherapy)
* No concurrent radiotherapy
Surgery
* Not specified
Other
* Recovered from prior therapy
* At least 4 weeks since prior anticancer investigational agents
* No prior localized antitumor therapy for malignant glioma
* No other concurrent investigational agent
* No other concurrent anticancer (including alternative anticancer medicines/treatment) agent or therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
21 Years
Study:
NCT00074334
Study Brief:
Protocol Section:
NCT00074334