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 @ 6:52 PM
Ignite Modification Date:
2025-12-24 @ 6:52 PM
NCT ID:
NCT00635557
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven WHO Grade IV glioblastoma multiforme at time of diagnosis or relapse
* Prior treatment with radiotherapy and temozolomide
* Evidence of measurable recurrent or residual primary tumor by contrast-enhanced MRI
* Be a minimum of 4 weeks since prior surgical resection, major surgical procedure, radiation therapy or cytotoxic chemotherapy (6 weeks since prior BCNU or CCNU)
* Have a Performance Scale of Karnofsky \> 60%, ECOG \< 2 or WHO \< 2
* If steroids are needed, be on a stable or decreasing dose of steroids for at least 1 week
Exclusion Criteria:
* Hypersensitivity to Cremophor EL
* Have evidence of current/active intratumor hemorrhage by MRI
* Have greater than second relapse
* Have had prior treatment with platinum-based chemotherapy
* Have cardiovascular disease
* Have cerebrovascular disease
* Have uncontrolled hypertension
* Have a cardiac ejection fraction \< 50%
* Have Troponin-I elevated above the normal range
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00635557
Study Brief:
Protocol Section:
NCT00635557