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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

NCT01107522 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-09-09

No results posted yet for this study

Summary

The purpose of this study is to determine the safety, tolerability, and the maximum tolerated dose/recommended phase II dose of carboxyamidotriazole orotate (CTO) as a single agent in patients with advanced or metastatic solid tumors; in combination with oral Temodar® in patients with glioblastoma or other recurrent malignant gliomas; or in combination with oral Temodar® and radiation therapy in patients with newly diagnosed glioblastoma or other malignant gliomas.

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

Sponsors & Collaborators

  • Tactical Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Matthew Taylor, MD · Oregon Health and Sciences University

  • Elena Pentsova, MD · Memorial Sloan Kettering Cancer Center

  • Walter Urba, MD, PhD · Providence Health & Services

  • Katharine McNeill, MD · NYU MEDICAL CENTER

  • Lisa DeAngelis, MD · Memorial Sloan Kettering Cancer Center

  • Timothy Chan, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2025-01-31
Completion
2026-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01107522 on ClinicalTrials.gov