Arsenic Trioxide, Temozolomide, and Radiation Therapy in Treating Patients With Malignant Glioma That Has Been Removed By Surgery

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

May 31, 2005

Primary Completion Date

May 31, 2021

Study Completion Date

May 31, 2021

Conditions
Brain and Central Nervous System Tumors
Interventions
DRUG

arsenic trioxide

Arsenic trioxide administered intravenously at a dose of 0.20mg/kg Daily x 5 week then twice per week

DRUG

temozolomide

Temozolomide administered orally once per day 1 hour prior to radiation therapy at a dose of 75 mg/m2 x 42 days; at a dose of 200mg/m2 for 5 days every cycle (1 cycle = 28 days) after radiation therapy

RADIATION

radiation therapy

All patients will receive 5940-6120 cGy of radiation therapy as 28-33 treatments/fractions (180-200 cGy/treatment) depending on whether they receive standard 3-D conformal radiation therapy or intensity modulated radiation therapy.

Trial Locations (3)

60540

Edward Cancer Center, Naperville

60611-2998

Hematology-Oncology Associates of Illinois, Chicago

60611-3013

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Cephalon

INDUSTRY

collaborator

CTI BioPharma

INDUSTRY

lead

Northwestern University

OTHER