6-TG, Capecitabine and Celecoxib Plus TMZ or CCNU for Anaplastic Glioma Patients - Study Results

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Anaplastic Glioma of Brain Glioblastoma Multiforme Brain Cancer
Interventions:	Drug: Capecitabine Drug: Celecoxib (Celebrex) Drug: Temozolomide Drug: Lomustine Drug: 6-Thioguanine

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period: September 23, 2003 to June 15, 2009. All patients 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 75 enrolled participants, one was excluded prior to assignment to groups. The Anaplastic Tumors Arms (Arm 1 and Arm 2) were combined for recruitment demographics and data collection.

Reporting Groups

	Description
Anaplastic Tumors	6-TG 80 mg/m^2 orally (PO) every 6 hours Day 1-3; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR Lomustine 100 mg/m^2 PO on Day 4; Capecitabine 825 mg/m^2 every 12 hours; and Celebrex 400 mg PO every 12 hours for 13 days for 28 day course.
Glioblastoma Multiforme	6-TG 80 mg/m^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle. Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide.

Description

Anaplastic Tumors

6-TG 80 mg/m^2 orally (PO) every 6 hours Day 1-3; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR Lomustine 100 mg/m^2 PO on Day 4; Capecitabine 825 mg/m^2 every 12 hours; and Celebrex 400 mg PO every 12 hours for 13 days for 28 day course.

Glioblastoma Multiforme

6-TG 80 mg/m^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle.

Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide.

Participant Flow: Overall Study

	Anaplastic Tumors	Glioblastoma Multiforme
STARTED	31	43
COMPLETED	31	43
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Anaplastic Tumors	6-TG 80 mg/m^2 orally (PO) every 6 hours Day 1-3; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR Lomustine 100 mg/m^2 PO on Day 4; Capecitabine 825 mg/m^2 every 12 hours; and Celebrex 400 mg PO every 12 hours for 13 days for 28 day course.
Glioblastoma Multiforme	6-TG 80 mg/m^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle. Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide.
Total	Total of all reporting groups

Description

Anaplastic Tumors

6-TG 80 mg/m^2 orally (PO) every 6 hours Day 1-3; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR Lomustine 100 mg/m^2 PO on Day 4; Capecitabine 825 mg/m^2 every 12 hours; and Celebrex 400 mg PO every 12 hours for 13 days for 28 day course.

Glioblastoma Multiforme

6-TG 80 mg/m^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle.

Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide.

Total

Total of all reporting groups

Baseline Measures

	Anaplastic Tumors	Glioblastoma Multiforme	Total
Number of Participants [units: participants]	31	43	74
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	29	34	63
>=65 years	2	9	11
Gender [units: participants]
Female	14	15	29
Male	17	28	45
Region of Enrollment [units: participants]
United States	31	43	74

Outcome Measures

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1. Primary:

12 Month-progression-free Survival for Participants With Anaplastic Tumors [ Time Frame: 12 months ]

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2. Primary:

6 Month Progression-free Survival for Participants With Glioblastoma [ 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: Charles A. Conrad, MD / Professor
Organization: UT MD Anderson Cancer Center
phone: 713-745-1896
e-mail: skang@mdanderson.org

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00504660 History of Changes
Other Study ID Numbers:	2003-0600
Study First Received:	July 18, 2007
Results First Received:	December 6, 2011
Last Updated:	December 6, 2011
Health Authority:	United States: Institutional Review Board