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CTO + Temodar® for Glioblastoma

Phase 1
Waitlist Available
Led By Lisa DeAngelis, MD
Research Sponsored by Tactical Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have received prior anticancer therapy or not be eligible for any established conventional therapy whether surgical or pharmacologic.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected prior to enrollment
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a new cancer drug, carboxyamidotriazole orotate (CTO). It will be given alone or in combination with other drugs to patients with brain tumors.

Who is the study for?
Adults with certain brain tumors (glioblastoma or malignant gliomas) that are new, recurring, or have not responded to standard treatments. Participants must be in good health otherwise, with proper liver and kidney function, and cannot be pregnant or breastfeeding. They should not have other recent cancers (except some skin cancers and localized breast/cervix cancers), uncontrolled illnesses like heart disease or diabetes, active infections, HIV/HBV/HCV infection, a high risk of bleeding, psychiatric disorders affecting compliance, or be on specific drugs affecting the liver enzyme CYP3A4.Check my eligibility
What is being tested?
The trial is testing Carboxyamidotriazole Orotate (CTO) alone for advanced solid tumors; combined with Temodar® for recurrent brain tumors; and together with Temodar® plus radiation therapy for newly diagnosed brain tumors. The goal is to find the safest dose that can be tolerated without causing severe side effects.See study design
What are the potential side effects?
Possible side effects include those common to cancer therapies such as fatigue, nausea, blood count changes leading to increased infection risk or bleeding tendencies. Specific risks related to CTO are not detailed but would likely align with typical chemotherapy-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have received previous cancer treatment or are not eligible for standard cancer treatment like surgery or medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre- and post-dose during cycle 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre- and post-dose during cycle 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
Exploratory Objective
Pharmacokinetics (maximum concentration, Tmax, AUC, T1/2, clearance, volume of distribution)
Preliminary tumor response
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm CExperimental Treatment1 Intervention
Combination CTO, Temodar®, Radiation therapy
Group II: Arm BExperimental Treatment1 Intervention
Combination CTO and Temodar®
Group III: Arm AExperimental Treatment1 Intervention
Single Agent CTO

Find a Location

Who is running the clinical trial?

Tactical Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
26 Total Patients Enrolled
Lisa DeAngelis, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
20 Total Patients Enrolled
Timothy Chan, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Carboxyamidotriazole Orotate (CTO) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT01107522 — Phase 1
Brain Tumor Research Study Groups: Arm A, Arm B, Arm C
Brain Tumor Clinical Trial 2023: Carboxyamidotriazole Orotate (CTO) Highlights & Side Effects. Trial Name: NCT01107522 — Phase 1
Carboxyamidotriazole Orotate (CTO) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01107522 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollment opportunities for this trial still available?

"This examination has been closed to recruitment, with initial posting taking place on May 1st 2010 and the latest update being April 23rd 2018. Patients looking for alternative clinical trials can explore 1610 relapse-related studies or 206 CTO/Temodar® studies that are actively recruiting now."

Answered by AI

Has the FDA sanctioned CTO and Temodar® for clinical usage?

"Our medical experts at Power deem that CTO and Temodar® have a safety rating of 1 due to the fact Phase 1 trials are still underway, indicating limited data on efficacy and safety."

Answered by AI

Does this trial involve any never-before-seen approaches?

"Presently, 206 active studies related to CTO and Temodar® can be found in 36 countries across 935 cities. The inaugural trial began back in 2002 under the auspices of Schering-Plough with 60 participants at Phase 2 approval level. In subsequent years since then, 295 trials have been satisfactorily concluded."

Answered by AI

In what ways are CTO and Temodar® typically employed?

"CTO and Temodar® is usually used to address nitrosourea treatment, but has also demonstrated efficacy in treating refractory neuroblastoma, advanced mycosis fungoides, advance directives and other ailments."

Answered by AI

How many participants are taking part in this research project?

"Unfortunately, this clinical trial has ceased participant recruitment. It was first opened on May 1st 2010 and last modified on April 23rd 2018. However, there are 1610 trials actively seeking patients with relapse issues as well as 206 studies requiring participants for CTO and Temodar® treatments currently available."

Answered by AI

Have any other trials been conducted that involve CTO and Temodar®?

"CTO and Temodar® first entered the research domain with a study conducted in 2002 by Memorial Sloan Kettering Cancer Center. Since then, 295 studies have been finished while an additional 206 are currently being organised. Of these active trials, many can be found within New york City."

Answered by AI
~7 spots leftby Mar 2025