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

Phase 1

Active, not recruiting

• Conditions: Solid Tumors, Glioblastoma, Recurrent Malignant Gliomas
• Interventions: Drug: CTO; Drug: CTO, Temodar®, Radiation therapy; Drug: CTO and Temodar®

• Registration Number: NCT01107522
• Lead Sponsor: Tactical Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-16
• Study First Submitted QC: 2010-04-20
• Study First Posted: 2010-04-21
• Study Start: 2010-05
• Status Verified: 2023-09
• Last Update Submitted: 2024-07-06
• Last Update Posted: 2024-07-09
• Primary Completion: 2025-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A	CTO	Single Agent CTO
Arm C	CTO, Temodar®, Radiation therapy	Combination CTO, Temodar®, Radiation therapy
Arm B	CTO and Temodar®	Combination CTO and Temodar®

Primary Outcome Measures

Name	Time	Method
To determine the MTD/RD of single agent CTO in patients with advanced or metastatic solid tumors; or CTO in combination with Temodar® in patients with glioblastoma or other recurrent malignant gliomas	Duration of the study	To determine the highest tolerated dose of CTO, based on safety data and occurence of dose-limiting toxicity, in patients with advanced or metastatic solid tumors. In the second stage of the study, to determine the highest tolerated dose of CTO in combination with Temodar®, based on safety data and toxicity profile, in patients with glioblastoma or other recurrent malignant gliomas. In the third stage of the study, to determine the highest tolerated dose of CTO in combination with Temodar® and radiation therapy based on safety data and toxicity profile, in patients with newly diagnosed glioblastoma or other malignant gliomas.

Secondary Outcome Measures

Name	Time	Method
Preliminary tumor response	after every 2 cycles	RECIST 1.1 (Arm A); Macdonald Criteria (Arms B and C)
Pharmacokinetics (maximum concentration, Tmax, AUC, T1/2, clearance, volume of distribution)	pre- and post-dose during cycle 1	Plasma concentrations and PK parameters will be determined for single agent CTO (Arm A), or CTO in combination with Temodar® (Arm B); plasma concentrations and PK parameters will be determined for Temodar®, or CTO and Temodar® in combination with radiation therapy (Arm C).
Voluntary Exploratory objective	collected prior to enrollment	To investigate effect of CTO on tumor growth based on genotype
Exploratory Objective	Duration of study	To investigate effect of CTO alone and in combination with Temodar® on gene expression in scalp hair

Trial Locations

Locations (4)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

New York University; 🇺🇸 New York, New York, United States

Oregon Health and Sciences University; 🇺🇸 Portland, Oregon, United States

Providence Cancer Center; 🇺🇸 Portland, Oregon, United States