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 @ 11:31 PM
Ignite Modification Date:
2025-12-24 @ 11:31 PM
NCT ID:
NCT00005856
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed supratentorial grade IV astrocytoma
* Glioblastoma multiforme
* Subtotal resection or biopsy with measurable and contrast-enhancing disease on the postoperative, pretreatment MRI/CT scan
* Performance status - Karnofsky 60-100%
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9.0 g/dL
* Bilirubin normal
* Creatinine normal
* Creatinine clearance at least 60 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No serious concurrent infection or medical illness that would jeopardize ability to receive protocol chemotherapy with reasonable safety
* No other prior malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer
* No grade 2 or greater pre-existing sensory neuropathy
* No history of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol chemotherapy
* Mini mental score at least 15
* No prior immunotherapy for glioblastoma multiforme
* No prior biologic therapy for glioblastoma multiforme, including:
* Immunotoxins
* Immunoconjugates
* Antiangiogenesis compounds
* Antisense
* Peptide receptor antagonists
* Interferons
* Interleukins
* Tumor infiltrating lymphocytes
* Lymphokine activated killer cells
* Gene therapy
* No concurrent filgrastim (G-CSF)
* No prior chemotherapy for glioblastoma multiforme
* No prior hormonal therapy for glioblastoma multiforme
* Prior glucocorticoid therapy for glioblastoma multiforme allowed
* Must be maintained on a stable (lowest required dose) corticosteroid regimen for at least 5 days before and during study
* No concurrent dexamethasone as an antiemetic
* No prior radiotherapy for glioblastoma multiforme
* Recovered from immediate postoperative period
* At least 10 days since prior anticonvulsant drug that induces hepatic metabolic enzymes
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00005856
Study Brief:
Protocol Section:
NCT00005856