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Thalidomide and Temozolomide or Camptothecin-11 (CPT-11) in Patients With Gliomas

NCT00412542 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2012-02-28

Study results available
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Summary

Objectives:

1.1 To determine the efficacy, as measured by 6 month progression-free survival, of therapy with thalidomide combined with CPT-11 in the treatment of patients with recurrent and/or progressive malignant gliomas.

1.2 To determine the rate of measureable clinical response in patients treated with Thalidomide and CPT-11.

1.3 To determine Thrombotic thrombocytopenic purpura (TTP), overall survival and unexpected toxicity of Thalidomide and CPT-11 used in recurrent malignant gliomas.

1.4 To determine changes in dynamic magnetic resonance imaging (MRI) as a surrogate marker for treatment effect.

Conditions

Interventions

DRUG

Thalidomide

100 mg PO (by mouth) daily for 8 weeks

DRUG

CPT-11

125 mg/m\^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest

PROCEDURE

MRI Scan

Dynamic MRI scan with dye injection through vein, every 6 weeks

PROCEDURE

Quantitative Sensory Tests (QST)

QST, every 12 weeks, to check for any nerve problems that may be present before starting treatment; by touching a small machine tests are done on feeling of touch, vibration, and temperature.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Vinay K. Puduvalli, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00412542 on ClinicalTrials.gov