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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00412542
First Posted: December 18, 2006
Last Update Posted: February 28, 2012
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.
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
Results First Submitted: February 8, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Glioblastoma Multiforme
Glioma
Interventions: Drug: Thalidomide
Drug: CPT-11
Procedure: MRI Scan
Procedure: Quantitative Sensory Tests (QST)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: October 13, 2003 to October 22, 2008. All participants were recruited at UT MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 78 participants enrolled, three (3) were considered not evaluable.

Reporting Groups
  Description
Glioblastoma Multiforme: Thalidomide + CPT-11 Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
Anaplastic Gliomas: Thalidomide + CPT-11 Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.

Participant Flow:   Overall Study
    Glioblastoma Multiforme: Thalidomide + CPT-11   Anaplastic Gliomas: Thalidomide + CPT-11
STARTED   33   45 
COMPLETED   33   42 
NOT COMPLETED   0   3 
Withdrawal by Subject                0                2 
Not Eligible                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Glioblastoma Multiforme: Thalidomide + CPT-11 Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
Anaplastic Gliomas: Thalidomide + CPT-11 Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
Total Total of all reporting groups

Baseline Measures
   Glioblastoma Multiforme: Thalidomide + CPT-11   Anaplastic Gliomas: Thalidomide + CPT-11   Total 
Overall Participants Analyzed 
[Units: Participants]
 33   45   78 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   31   41   72 
>=65 years   2   4   6 
Gender 
[Units: Participants]
     
Female   8   19   27 
Male   25   26   51 
Region of Enrollment 
[Units: Participants]
     
United States   33   45   78 


  Outcome Measures

1.  Primary:   Number of Participants Progression Free at 6 Months With Malignant Gliomas   [ Time Frame: 6 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Vinay Puduvalli, MD / Associate Professor
Organization: UT MD Anderson Cancer Center
phone: 713-745-5769
e-mail: kuhunter@mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00412542     History of Changes
Other Study ID Numbers: DM02-595
First Submitted: December 15, 2006
First Posted: December 18, 2006
Results First Submitted: February 8, 2012
Results First Posted: February 28, 2012
Last Update Posted: February 28, 2012