Safety and Tolerability of Carboxyamidotriazole Orotate (CTO) in Solid Tumors or With Temodar® in Glioblastoma or Other Recurrent Malignant Gliomas or in Combination With Temodar® and Radiation Therapy for Patients With Newly Diagnosed Glioblastoma and Malignant Gliomas

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

May 31, 2010

Primary Completion Date

January 31, 2025

Study Completion Date

January 31, 2026

Conditions
Solid Tumors, Glioblastoma, Recurrent Malignant Gliomas
Interventions
DRUG

CTO

Oral administration daily for 28 day cycles; starting dose of CTO = 50 mg/m2

DRUG

CTO and Temodar®

"Oral administration of CTO daily for 28 day cycles, starting dose of CTO = 219 mg/m2.~Temodar® administered orally at fixed dose of 150 mg/m2 daily for Days 1-5 in a 28 day cycle.~Expansion Cohort of 6 patients on fixed dose of 600mg CTO/day Temodar® administered orally at fixed dose of 150 mg/m2 daily for Days 1-5 in a 28 day cycle"

DRUG

CTO, Temodar®, Radiation therapy

Oral administration of CTO daily for 28 day cycles; starting dose of CTO = 219 mg/m2 Temodar® administered orally at a dose of 75 mg/m2 daily during radiation therapy, then at 150mg/m2 for Days 1-5 of Cycle 1, and then up to 200 mg/m2 Days 1-5 of subsequent cycles Radiation: 3-dimensional conformal radiation therapy or, Radiation: intensity-modulated radiation therapy

Trial Locations (4)

10016

New York University, New York

10017

Memorial Sloan-Kettering Cancer Center, New York

97213

Providence Cancer Center, Portland

97239

Oregon Health and Sciences University, Portland

All Listed Sponsors
lead

Tactical Therapeutics, Inc.

INDUSTRY