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High Dose Camptothecin-11 (CPT-11) in Recurrent Unresectable Malignant Glioma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00283556
First Posted: January 30, 2006
Last Update Posted: January 20, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kentuckiana Cancer Institute
  Purpose
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.

Condition Intervention Phase
Malignant Glioma Drug: Irinotecan (Camptosar, CPT-11) Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of High Dose Irinotecan (Camptosar, CPT-11) in Patients With Recurrent Unresectable Malignant Glioma on Steroids/Anti-epileptics

Resource links provided by NLM:


Further study details as provided by Kentuckiana Cancer Institute:

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. [ Time Frame: 2008 ]

Estimated Enrollment: 30
Study Start Date: August 2001
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

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.

Experimental: 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.

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.

Experimental: 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.

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.


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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00283556


Locations
United States, Kentucky
Kentuckiana Cancer Institute
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Kentuckiana Cancer Institute
Investigators
Principal Investigator: Renato V. LaRocca, MD Director
  More Information

ClinicalTrials.gov Identifier: NCT00283556     History of Changes
Other Study ID Numbers: 1068114
44OE-ONC-0020-3
First Submitted: January 26, 2006
First Posted: January 30, 2006
Last Update Posted: January 20, 2010
Last Verified: January 2010

Keywords provided by Kentuckiana Cancer Institute:
High Dose Irinotecan
CPT-11
Camptosar
Malignant Glioma
Unresectable

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Irinotecan
Camptothecin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action