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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT00039494
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed diagnosis of 1 of the following:
* Glioblastoma multiforme (grade 4 astrocytoma)
* Gliosarcomas
* Other grade 4 astrocytoma variants (e.g., giant cell)
* Must be enrolled at least 1 week, but no more than 4 weeks, after prior biopsy or surgery
* Performance status - ECOG 0-2
* Performance status - Karnofsky 60-100%
* At least 6 months
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL
* Total bilirubin ≤ upper limit of normal (ULN)
* AST no greater than 2.5 times ULN
* Creatinine no greater than 1.5 times ULN
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No inability to take oral medications
* No requirement for IV alimentation
* No active uncontrolled peptic ulcer disease
* No abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome)
* No congenital abnormality (e.g., Fuch's dystrophy)
* No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
* No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)
* No prior allergy or intolerance to dacarbazine
* No other active malignancy requiring treatment
* No other concurrent uncontrolled illness
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior chemotherapy for any brain tumor
* No prior temozolomide
* No prior radiotherapy for any brain tumor
* No other concurrent investigational agents
* More than 21 days since prior major surgery (excluding neurosurgical biopsy or brain tumor resection)
* No prior surgical procedures affecting absorption
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No concurrent warfarin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00039494
Study Brief:
Protocol Section:
NCT00039494