Ph. II Treatment of Adults w Primary Malignant Glioma w Irinotecan + Temozolomide
Completed · Phase 2
Conditions studied: Glioblastoma
In brief
Objective: To determine activity of combo of Irinotecan + Temozolomide To further characterize any toxicity associated w combo of Irinotecan + Temozolomide
Key facts
- Study ID
- NCT00616005
- Run by
- Duke University
- People needed
- 41
- Starts
- 2005-11-01
- Expected to finish
- 2009-06-01
- Last updated by the study team
- 2014-08-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Duke University Health System — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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