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 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT00616005
Eligibility Criteria:
Inclusion Criteria:
* Pts have histologically proven supratentorial GBM
* Pts have newly diagnosed disease
* There must be measurable disease on contrast-enhanced magnetic resonance imaging performed \<14 days before drug administration. Those who underwent resection must have MRI \<72 hrs/ \>14 days after surgery
* Prior Surgical Resection/Biopsy: Although surgical resection is not required, pts must be treated \<42 days of surgery or biopsy
* Age \>18 yrs
* Karnofsky Performance Status \>70 percent
* Serum creatinine \< 1.5 x ULN
* Absolute neutrophil count \>1500 cells/microliter; platelet count \>100,000 cells/microliter
* Serum SGOT \& total bilirubin \<2.5 x ULN
* Signed informed consent, approved by IRB, will be obtained prior to initiating treatment
* Pts must agree to practice effective birth control measures while on study \& for 2 months after completing therapy
Exclusion Criteria:
* Pregnant/breast feeding women / women/men w reproductive potential not practicing adequate contraception. This therapy may be associated w potential toxicity to fetus/child that exceeds minimum risks necessary to meet health needs of mother
* Active infection requiring intravenous antibiotics
* Known diagnosis of HIV infection
* Pts w history of another primary malignancy that currently requires active intervention
* Pts unwilling/unable to comply w protocol due to serious medical/psychiatric condition
* Pts who underwent surgical resection for GBM \<2 weeks of start of treatment
* Pts who have received prior chemo, biologic therapy, XRT, interstitial brachytherapy/radiosurgery to brain
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00616005
Study Brief:
Protocol Section:
NCT00616005