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 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 1:04 AM
NCT ID:
NCT00613093
Eligibility Criteria:
Inclusion Criteria:
* Patients have recurrent/progressive Malignant Glioma (MG). Stereotactic biopsy at time of recurrence/progression is only required if radiation-induced necrosis is suspected
* Patients have MG resistant to Temodar, which is defined as \> or = to 25 percent increase in tumor growth on contrast enhanced MRI/CT within 8 weeks of last dose of Temodar
* Age \> or = to 18 years
* Evidence of measurable enhancing disease on contrast-enhanced MRI, unless medically contraindicated.
* Interval of at least 2 weeks between prior surgical resection/ 4 weeks between prior radiotherapy/chemotherapy, and enrollment on protocol unless there is unequivocal evidence of tumor progression. However, patients treated with chemotherapy agents such as VP-16 who would normally be retreated after shorter intervals may be treated at usual starting time even if less than 4 weeks from last prior dose of chemotherapy
* Karnofsky performance score \> or = to 60 percent
* Hematocrit \> 29 percent, absolute neutrophil count (ANC) \> 1,500 cells/microliter, platelets \> 100,000 cells/microliter
* Serum creatinine \<1.5 mg/dl, Blood Urea Nitrogen (BUN) \<25 mg/dl, Serum Glutamic Oxaloacetic Transaminase (SGOT) \& bilirubin \<1.5 x upper limit of normal (ULN)
* For patients on corticosteroids, they must have been on stable dose for 1 week prior to entry, if clinically possible, and dose should not be escalated over entry dose level
* Signed informed consent approved by Institutional Review Board (IRB) prior to patient entry
* If sexually active, patients will take contraceptive measures for duration of treatments
Exclusion criteria:
* Pregnancy
* Co-medication that may interfere with study results
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00613093
Study Brief:
Protocol Section:
NCT00613093