Temozolomide & RT Followed by Dose Dense vs Temozolomide & Retinoic Acid in Pts w/Glioblastoma

PHASE2CompletedINTERVENTIONAL
Enrollment

127

Participants

Timeline

Start Date

August 9, 2005

Primary Completion Date

May 4, 2017

Study Completion Date

May 4, 2017

Conditions
GlioblastomaGliomas
Interventions
DRUG

Temozolomide

Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.

DRUG

Temozolomide

Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.

Trial Locations (3)

10021

Memorial Sloan-Kettering Cancer Center, New York

11725

Memorial Sloan-Kettering Cancer Center at Commack, Commack

07920

Memorial Sloan-Kettering at Basking Ridge, Basking Ridge

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Schering-Plough

INDUSTRY

collaborator

Columbia University

OTHER

collaborator

Dana-Farber Cancer Institute

OTHER

lead

Memorial Sloan Kettering Cancer Center

OTHER