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

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00412542
First received: December 15, 2006
Last updated: February 8, 2012
Last verified: February 2012
Results First Received: February 8, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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  
Number of Participants  
[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


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00412542     History of Changes
Other Study ID Numbers: DM02-595
Study First Received: December 15, 2006
Results First Received: February 8, 2012
Last Updated: February 8, 2012
Health Authority: United States: Institutional Review Board