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 @ 5:28 PM
Ignite Modification Date:
2025-12-24 @ 5:28 PM
NCT ID:
NCT00006268
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven malignant glioma (grade 3 or 4)
* Anaplastic astrocytoma
* Glioblastoma multiforme
* Malignant mixed oligoastrocytoma
* Must have undergone cranial radiotherapy with tumor dose of at least 48 Gy and at least 12 weeks prior to study
* Must have undergone supratentorial brain tumor surgery or biopsy
* Must have radiographic evidence of recurrent or progressive supratentorial tumor compared with prior study
* Must have solid portion measuring 1.0-5.0 cm in maximum diameter
* Maximum of 1 satellite lesion allowed if separated from the primary mass by less than 3 cm
* No tumor crossing the midline
* No leptomeningeal tumor dissemination
* No impending herniation or spinal cord compression
* No uncontrolled seizures
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Hemoglobin at least 10 g/dL
* Platelet count at least 100,000/mm\^3
Hepatic:
* PT and PTT no greater than upper limit of normal (ULN)
* SGOT and SGPT no greater than 2.5 times ULN
* Bilirubin no greater than 2.0 mg/dL
Renal:
* Not specified
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior intralesional chemotherapy for malignant glioma
* At least 3 weeks since other prior chemotherapy (6 weeks since prior nitrosoureas) and recovered
* No concurrent chemotherapy
Endocrine therapy:
* Concurrent corticosteroids allowed, but dose must remain stable or be tapered during study
Radiotherapy:
* See Disease Characteristics
* No prior focal radiotherapy (e.g., any form of stereotactic radiotherapy or brachytherapy) for malignant glioma
Surgery:
* See Disease Characteristics
Other:
* Recovered from any prior therapy
* No other concurrent investigational agent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00006268
Study Brief:
Protocol Section:
NCT00006268