High Dose Camptothecin-11 (CPT-11) in Recurrent Unresectable Malignant Glioma
NCT ID: NCT00283556
Last Updated: 2010-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2001-08-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort #1
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.
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.
Cohort #2
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.
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.
Cohort #3
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* ECOG status of 2 or less
* no prior therapy with camptothecans
* on an enzyme-inducing antiepileptic
18 Years
ALL
No
Sponsors
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Kentuckiana Cancer Institute
OTHER
Principal Investigators
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Renato V. LaRocca, MD
Role: PRINCIPAL_INVESTIGATOR
Director
Locations
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Kentuckiana Cancer Institute
Louisville, Kentucky, United States
Countries
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Other Identifiers
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44OE-ONC-0020-3
Identifier Type: -
Identifier Source: secondary_id
1068114
Identifier Type: -
Identifier Source: org_study_id
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