Phase I/II Evaluation of Temozolomide and ZARNESTRA (R115777) for Recurrent and Progressive Glioblastoma Multiforme

This study has been completed.

Study NCT00050986 Information provided by M.D. Anderson Cancer Center

First Received on December 31, 2002. Last Updated on August 25, 2010 History of Changes

Results First Received: September 25, 2009

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Glioblastoma Multiforme
Interventions:	Drug: Temozolomide Drug: R115777

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Total of 55 participants recruited in between 12/30/2002 and 11/30/2005, all at M. D. Anderson Cancer Center.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
5 patients were not evaluated for response because of the following: 1 early, non-treatment related death; 3 withdrew consent; 1 discontinued for intercurrent illness (pneumonia).

Reporting Groups

	Description
Temozolomide and R115777	No text entered.

Participant Flow: Overall Study

[1]	Two participants had withdrawn consents before the study treatment was initiated.

Baseline Characteristics

Reporting Groups

	Description
Temozolomide and R115777	No text entered.

Baseline Measures

	Temozolomide and R115777
Number of Participants [units: participants]	55
Age [units: participants]
<=18 years	0
Between 18 and 65 years	52
>=65 years	3
Age [units: years] Median ( Full Range )	52 ( 21 to 84 )
Gender [units: participants]
Female	13
Male	42
Region of Enrollment [units: participants]
United States	55

Outcome Measures

1. Primary:

Maximal Tolerating Dose (MTD for Phase I) [ Time Frame: End of first cycle (4 weeks) evaluation ]

Show Outcome Measure 1

2. Secondary:

Progression-free Survival (Phase II) [ Time Frame: 6 months ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

Other Adverse Events

More Information

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
No text entered.

Results Point of Contact:

Name/Title: Mark Gilbert, MD
Organization: University of Texas, M. D. Anderson Cancer Center
e-mail: CR_study_registration@mdanderson.org

No publications provided

Responsible Party:	Mark R. Gilbert, MD / Professor, U.T. M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00050986 History of Changes
Other Study ID Numbers:	ID02-126
Study First Received:	December 31, 2002
Results First Received:	September 25, 2009
Last Updated:	August 25, 2010
Health Authority:	United States: Food and Drug Administration