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

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ClinicalTrials.gov Identifier: NCT00283556
Recruitment Status : Completed
First Posted : January 30, 2006
Last Update Posted : January 20, 2010
Sponsor:
Information provided by:
Kentuckiana Cancer Institute

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.

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

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Study Start Date : August 2001
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008


Arm Intervention/treatment
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.




Primary Outcome Measures :
  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. [ Time Frame: 2008 ]


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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

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

ClinicalTrials.gov Identifier: NCT00283556     History of Changes
Other Study ID Numbers: 1068114
44OE-ONC-0020-3
First Posted: January 30, 2006    Key Record Dates
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