Status:
COMPLETED
Ph. II Treatment of Adults w Primary Malignant Glioma w Irinotecan + Temozolomide
Lead Sponsor:
Duke University
Collaborating Sponsors:
Pfizer
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Objective: To determine activity of combo of Irinotecan + Temozolomide To further characterize any toxicity associated w combo of Irinotecan + Temozolomide
Detailed Description
Objectives of study are to determine activity of combo of Irinotecan + Temozolomide \& to further characterize any toxicity associated w combo of Irinotecan + Temozolomide. Temozolomide administered o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00616005
Start Date
November 1 2005
End Date
June 1 2009
Last Update
August 18 2014
Active Locations (1)
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1
Duke University Health System
Durham, North Carolina, United States, 27710