A Phase 1/2 interventional study of Irinotecan (Camptosar, CPT-11) in Malignant Glioma, sponsored by Kentuckiana Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-01-20.
Sponsored by Kentuckiana Cancer Institute · Phase 1/2, Interventional, and Treatment
The purpose of this study is to compare the response to treatment and side effects associated with high dose irinotecan in patients with recurrent brain tumors.
This is a phase I/II study of high dose irinotecan in patients with recurrent unresectable malignant glioma on steroids/anti-epileptics. The purpose is to compare the response to treatment and side effects associated with high dose irinotecan in patients with recurrent brain tumors.
1,425 studies on the registry are indexed under Glioma; 355 are open to participants now.
This study's planned enrollment of 30 is close to the median of 32 across 1,085 interventional studies indexed under Glioma.
Browse Glioma studies →Kentuckiana Cancer Institute is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Cohort #1--Irinotecan 750 mg/m2 IV over 90 minutes every (Q) 3 weeks x 15 patients. Additional increments of 50 mg/m2 for subsequent cohorts until MTD is reached.
Drug: Irinotecan (Camptosar, CPT-11)
Cohort #2--Irinotecan 500 mg/m2 IV over 90 minutes Q 2 weeks x 3 patients. Additional increments of 50 mg/m2 for subsequent cohorts until MTD is reached.
Drug: Irinotecan (Camptosar, CPT-11)
Cohort #3--Irinotecan 600 mg/m2 IV over 90 minutes Q 2 weeks x 3 patients. Additional increments of 50 mg/m2 for subsequent cohorts until MTD is reached.
Drug: Irinotecan (Camptosar, CPT-11)
Cohort #1--Irinotecan 750 mg/m2 IV over 90 minutes Q 3 weeks x 15 patients; Cohort #2--Irinotecan 500 mg/m2 IV over 90 minutes Q 2 weeks x 3 patients; Cohort #3--Irinotecan 600 mg/m2 IV over 90 minutes Q 2 weeks x 3 patients. Additional increments of 50 mg/m2 for subsequent cohorts until MTD is reached.
The purpose of this study is to compare the response to treatment and side effects associated with high dose irinotecan in patients with recurrent brain tumors.
Time frame: 2008
This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Irinotecan
Kentuckiana Cancer Institute