Back to resultsHigh Dose Camptothecin-11 (CPT-11) in Recurrent Unresectable Malignant Glioma
Primary Purpose
Malignant Glioma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Irinotecan (Camptosar, CPT-11)
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Glioma focused on measuring High Dose Irinotecan, CPT-11, Camptosar, Malignant Glioma, Unresectable
Eligibility Criteria
Inclusion Criteria: recurrent, unresectable primary CNS neoplasm per MRI ECOG status of 2 or less no prior therapy with camptothecans on an enzyme-inducing antiepileptic
Sites / Locations
- Kentuckiana Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort #1
Cohort #2
Cohort #3
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00283556
First Posted
January 26, 2006
Last Updated
January 18, 2010
Sponsor
Kentuckiana Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT00283556
Brief Title
High Dose Camptothecin-11 (CPT-11) in Recurrent Unresectable Malignant Glioma
Official Title
Phase I/II Study of High Dose Irinotecan (Camptosar, CPT-11) in Patients With Recurrent Unresectable Malignant Glioma on Steroids/Anti-epileptics
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kentuckiana Cancer Institute
4. Oversight
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Glioma
Keywords
High Dose Irinotecan, CPT-11, Camptosar, Malignant Glioma, Unresectable
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort #1
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort #2
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort #3
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Irinotecan (Camptosar, CPT-11)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
recurrent, unresectable primary CNS neoplasm per MRI
ECOG status of 2 or less
no prior therapy with camptothecans
on an enzyme-inducing antiepileptic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renato V. LaRocca, MD
Organizational Affiliation
Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kentuckiana Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
High Dose Camptothecin-11 (CPT-11) in Recurrent Unresectable Malignant Glioma
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