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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT00306618
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed diagnosis of a 1st or 2nd recurrent/progressive primary WHO grade IV malignant glioma (glioblastoma multiforme or gliosarcoma).
* 18 years or older
* An interval of at least 2 weeks between prior surgical resection or any major surgery or 4 weeks between prior radiotherapy or chemotherapy (except nitrosoureas which require 6 weeks)
* Karnofsky performance score equal to or greater than 70%
* Hematocrit greater than 29%, absolute neutrophil count greater than 1,500 cells/micro liters, platelets greater than 100,000 cells/ micro liters
* Serum creatinine less than 1.5 X upper limit of normal (ULN), serum SGOT less than 2.5 X ULN; and bilirubin less than 1.5 times ULN
* Signed informed consent form and authorization for use and disclosure of protected health information approved by the IRB prior to patient entry
* Agree to use effective contraceptive methods
Exclusion Criteria:
* Current, active systemic bleeding or excessive risk of bleeding
* Be pregnant or lactating; not employing effective birth control
* Concurrent severe and/or uncontrolled medical disease
* Impairment of gastrointestinal (GI) function/disease
* Requirement for therapy with coumadin (warfarin sodium)
* Patient is less than 5 years free of another primary malignancy
* Patients unwilling to or unable to comply with the protocol
* Grade 2 or greater peripheral sensory neuropathy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00306618
Study Brief:
Protocol Section:
NCT00306618