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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT00047294
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed supratentorial glioblastoma multiforme or gliosarcoma
* Completed standard external beam radiotherapy within the past 5 weeks
* Stable disease by MRI or CT scan
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 60-100%
Life expectancy
* More than 4 months
Hematopoietic
* Absolute neutrophil count at least 1,500/mm3
* Platelet count at least 100,000/mm3
* No history of bleeding disorder
Hepatic
* Bilirubin less than 1.5 mg/dL
* SGPT less than 2.5 times normal
* Alkaline phosphatase less than 2.5 times normal
Renal
* BUN less than 1.5 times upper limit of normal (ULN) OR
* Creatinine less than 1.5 times ULN
Cardiovascular
* No deep vein thrombosis within the past 3 weeks (must be clinically stable)
Pulmonary
* No pulmonary embolism within the past 3 weeks (must be clinically stable)
Other
* Must participate in System for Thalidomide Education and Prescribing Safety program
* No peripheral neuropathy grade 2 or greater
* No active infection
* No concurrent illness that may obscure toxicity or dangerously alter drug metabolism
* No other serious concurrent illness
* No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use 2 forms of effective contraception for 1 month before, during, and for 1 month after study
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior thalidomide
* No concurrent immunotherapy
* No concurrent prophylactic filgrastim (G-CSF)
Chemotherapy
* No prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy
* No concurrent hormonal therapy
* Concurrent corticosteroids must be at stable or decreasing dose over the past 7 days
Radiotherapy
* See Disease Characteristics
* No concurrent radiotherapy
Surgery
* No concurrent surgery
Other
* No other concurrent anticancer therapy
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00047294
Study Brief:
Protocol Section:
NCT00047294