Ph. II Treatment of Adults w Primary Malignant Glioma w Irinotecan + Temozolomide

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Objective:

To determine activity of combo of Irinotecan + Temozolomide To further characterize any toxicity associated w combo of Irinotecan + Temozolomide

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Pfizer
• Treatments: Camptothecin; Dacarbazine; Irinotecan; Temozolomide

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