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

This study has been completed.
Sponsor:
Information provided by:
Kentuckiana Cancer Institute
ClinicalTrials.gov Identifier:
NCT00283556
First received: January 26, 2006
Last updated: January 18, 2010
Last verified: January 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00283556     History of Changes
Other Study ID Numbers: 1068114, 44OE-ONC-0020-3
Study First Received: January 26, 2006
Last Updated: January 18, 2010
Health Authority: United States: Institutional Review Board

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
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014