NCT02871843 - RRx-001 + Radiation + Temozolomide In Newly Diagnosed Glioblastoma and Anaplastic Gliomas | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 14, 2017

Primary Completion Date

October 11, 2019

Study Completion Date

September 19, 2021

Conditions

GlioblastomaOligodendrogliomaAnaplastic Oligodendroglioma

Interventions

DRUG

RRx-001 dose escalation with TMZ + RT

Dose escalation of RRx-001. Dose levels of 0.5, 1.0, 2.0 and 4.0 mg, once weekly.

RADIATION

Radiation

Conformal or intensity-modulated radiotherapy (60 Gy in 2 Gy fractions) given 5 days a week for 30 fractions (about 6 weeks)

DRUG

Fixed dose Temozolomide (75 mg/m2)

Oral temozolomide 75 mg/m2 daily for 6 weeks

DRUG

TMZ Maintenance

TMZ maintenance at 150-200 mg/m2

Trial Locations (3)

Weill Cornell Brain Tumor Center, New York

University of California San Francisco (UCSF), San Francisco

The Cancer Institute of New Jersey (Rutgers University), New Brunswick