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 @ 10:21 PM
Ignite Modification Date:
2025-12-24 @ 10:21 PM
NCT ID:
NCT00003535
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma) that is recurrent or progressive or with residual tumor after standard therapy, including radiotherapy
* Measurable tumor by MRI scan performed within two weeks prior to study entry
* Male or female patients
* Children 6 months to 17 years
* Performance status: Karnofsky 60-100%
* Life expectancy of at least 2 months
* WBC greater than 1,500/mm\^3
* Platelet count greater than 50,000/mm\^3
* No evidence of hepatic or renal insufficiency and a total bilirubin and serum creatinine no greater than 2.5 mg/dL and SGOT/SGPT no greater than 5 times upper limit of normal
* Must have recovered from adverse effect of previous therapy
* At least 8 weeks elapsed since last dose of radiation
* At least 4 weeks elapsed since last dose of chemotherapy (6 weeks for nitrosoureas)
* Corticosteroids permitted using the smallest dose that is compatible with preservation of optimal neurologic function
* Acceptable methods of birth control (in females of child-bearing potential or in sexually active males)during and up to four weeks following completion of study
Exclusion Criteria:
* Prior A10 and AS2-1 treatment
* Severe heart disease
* Uncontrolled hypertension
* Lung disease
* Hepatic failure
* Serious active infections, fever or other serious concurrent disease that would interfere with the evaluation of the treatment drug.
* Pregnant or nursing
* Serious concurrent disease
* Concurrent antineoplastic or immunomodulatory agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
18 Years
Study:
NCT00003535
Study Brief:
Protocol Section:
NCT00003535