CTO + Temodar® for Glioblastoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called carboxyamidotriazole orotate (CTO) for certain brain tumors, such as glioblastoma. The main goal is to assess the safety and tolerability of CTO, both alone and in combination with Temodar® (an oral chemotherapy drug) and possibly radiation therapy. The study seeks patients with advanced brain tumors who have not responded to other treatments. Participants should have measurable tumors on MRI scans and, if applicable, have undergone previous radiation treatment. This trial may suit those experiencing tumor progression despite standard therapies. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop all current medications, but you cannot take medications that are known CYP3A4 inhibitors or inducers. If you are on anti-epileptic drugs, they must not be CYP3A4 inhibitors or inducers, and you should be on a stable dose for at least 2 weeks.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that carboxyamidotriazole orotate (CTO) is generally safe for use alone or with other cancer treatments. In earlier studies, CTO proved safe for patients with advanced tumors, with doses ranging from 75 to 427 mg/m² per day causing no serious side effects. Another study demonstrated that CTO was well-tolerated when combined with Temodar® (a chemotherapy drug), with no severe side effects reported, making it a promising option for those with glioblastoma, a type of brain cancer.
When combined with Temodar® and radiation therapy, CTO remains safe and manageable. The most common side effects were mild, such as nausea and tiredness. Overall, these findings suggest that CTO, whether used alone or with other treatments, has an acceptable safety profile for cancer patients.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for glioblastoma because they explore new ways to enhance effectiveness against this aggressive brain cancer. Carboxyamidotriazole Orotate (CTO) is a unique compound that disrupts cancer cell signaling, potentially slowing tumor growth. When combined with Temodar®, a chemotherapy standard, or paired with radiation therapy, there's hope these combinations might boost overall treatment efficacy. Unlike traditional treatments that mainly rely on Temodar® alone, these new approaches could offer a more comprehensive attack on the cancer cells, potentially leading to better outcomes for patients.
What evidence suggests that this trial's treatments could be effective for glioblastoma?
Research has shown that Carboxyamidotriazole Orotate (CTO) may help treat brain cancers. In one study, 67% of patients benefited from the treatment, and 26% experienced a noticeable improvement. Some patients even had a complete response, significantly improving their cancer symptoms. In this trial, participants in Arm A will receive CTO as a single agent.
In Arm B, participants will receive a combination of CTO and Temodar®, which is generally well tolerated and may improve survival rates for glioblastoma patients. Arm C will explore the combination of CTO, Temodar®, and radiation therapy. Temodar® alone is already known to help when used with radiation, so these combinations could be even more effective. These findings suggest that using CTO with Temodar® might offer new hope for treating glioblastoma.12678Who Is on the Research Team?
Matthew Taylor, MD
Principal Investigator
Oregon Health and Sciences University
Walter Urba, MD, PhD
Principal Investigator
Providence Health & Services
Katharine McNeill, MD
Principal Investigator
NYU MEDICAL CENTER
Timothy Chan, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Elena Pentsova, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Lisa DeAngelis, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CTO as a single agent or in combination with Temodar® and radiation therapy to determine the maximum tolerated dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
Exploratory Objective
Investigate the effect of CTO on gene expression and tumor growth
What Are the Treatments Tested in This Trial?
Interventions
- Carboxyamidotriazole Orotate (CTO)
- Radiation therapy
- Temodar®
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tactical Therapeutics, Inc.
Lead Sponsor