High Dose Camptothecin-11 (CPT-11) in Recurrent Unresectable Malignant Glioma
Phase I/II Study of High Dose Irinotecan (Camptosar, CPT-11) in Patients With Recurrent Unresectable Malignant Glioma on Steroids/Anti-epileptics
2 other identifiers
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2001
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2001
CompletedFirst Submitted
Initial submission to the registry
January 26, 2006
CompletedFirst Posted
Study publicly available on registry
January 30, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedJanuary 20, 2010
January 1, 2010
7.3 years
January 26, 2006
January 18, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
2008
Study Arms (3)
Cohort #1
EXPERIMENTALCohort #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.
Cohort #2
EXPERIMENTALCohort #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.
Cohort #3
EXPERIMENTALCohort #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
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
You may qualify if:
- recurrent, unresectable primary CNS neoplasm per MRI
- ECOG status of 2 or less
- no prior therapy with camptothecans
- on an enzyme-inducing antiepileptic
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kentuckiana Cancer Institute
Louisville, Kentucky, 40202, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Renato V. LaRocca, MD
Director
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 26, 2006
First Posted
January 30, 2006
Study Start
August 1, 2001
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
January 20, 2010
Record last verified: 2010-01