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 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
NCT ID:
NCT00087061
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed malignant glioma (glioblastoma multiforme, anaplastic astrocytoma, or anaplastic oligodendroglioma)
* Recurrent or progressive primary CNS neoplasm by contrast-enhanced MRI
* Tumor progression after prior surgery, radiotherapy, or chemotherapy
* Measurable or evaluable disease
* Failed prior standard curative or palliative therapy (phase I only)
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 60-100%
Life expectancy
* At least 3 months
Hematopoietic
* Absolute neutrophil count ≥ 2,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* SGPT and SGOT ≤ 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases are present)
* Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
* Bilirubin normal
Renal
* Creatinine ≤ 1.5 times ULN
Cardiovascular
* No myocardial infarction with the past year
* No heart failure (including cardiac insufficiency controlled by digitalis and diuretics)
* No irreversible arrhythmias requiring permanent medication
* No uncontrolled hypertension
Gastrointestinal
* No gastrointestinal dysfunction that would alter absorption or motility, such as any of the following:
* Active peptic ulcer
* Inflammatory bowel disease
* Known intolerance to lactose
* Malabsorption syndromes
* Intestinal sub-occlusion
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception
* No active infection
* No mentally incapacitated patients
* No other concurrent severe disease that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent immunotherapy
Chemotherapy
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
* No more than 1 prior chemotherapy regimen
* No other concurrent chemotherapy
Endocrine therapy
* Concurrent corticosteroids allowed if dose stable for the past 2 weeks
* No concurrent hormonal therapy
Radiotherapy
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery
* See Disease Characteristics
* At least 3 weeks since prior surgical resection
* No prior gastrointestinal surgery that would affect drug absorption
Other
* More than 4 weeks since prior participation in any other investigational drug study
* More than 72 hours since prior systemic antibiotics
* No concurrent H2 antagonists, antacids, or proton pump inhibitors
* If any of these therapies are necessary, ≥ 3 hours must elapse after gimatecan administration
* No other concurrent anticancer therapy
* No other concurrent investigational drugs
* No other concurrent immunosuppressive agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00087061
Study Brief:
Protocol Section:
NCT00087061