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

History of Changes

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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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 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

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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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

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