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

January 18, 2010 updated by: Kentuckiana Cancer Institute

Phase I/II Study of High Dose Irinotecan (Camptosar, CPT-11) in Patients With Recurrent Unresectable Malignant Glioma on Steroids/Anti-epileptics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Kentuckiana Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kentuckiana Cancer Institute

Investigators

  • Principal Investigator: Renato V. LaRocca, MD, Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

January 26, 2006

First Submitted That Met QC Criteria

January 26, 2006

First Posted (ESTIMATE)

January 30, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

January 20, 2010

Last Update Submitted That Met QC Criteria

January 18, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1068114
  • 44OE-ONC-0020-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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