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CTO + Temodar® for Glioblastoma
Phase 1
Waitlist Available
Led By Antonio Omuro, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected prior to enrollment
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre- and post-dose during cycle 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre- and post-dose during cycle 1
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
Exploratory Objective
Pharmacokinetics (maximum concentration, Tmax, AUC, T1/2, clearance, volume of distribution)
Preliminary tumor response
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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
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Who is running the clinical trial?
Tactical Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
26 Total Patients Enrolled
Walter Urba, MD, PhDProvidence Health & Services
Katharine McNeill, MDNYU MEDICAL CENTER
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Requirements for being included in Treatment Arm A.Your bone marrow must be functioning properly, which means you need to have enough neutrophils and platelets in your blood.Your liver must be functioning well, and your bilirubin levels, as well as AST and ALT levels, should not exceed certain limits. If you have Gilbert's disease, you may not qualify for the study.You have a medical condition that increases your risk of bleeding.You must have fully recovered from any side effects of previous treatments, except for hair loss, and your condition must be stable or improving.You must be healthy enough to carry out daily activities with little to no assistance.You have received previous cancer treatment or are not eligible for standard cancer treatment like surgery or medication.You have a mental health condition that may make it difficult for you to understand and follow the study guidelines.You have seizures that are not being controlled.You have been diagnosed with advanced or metastatic solid tumors that have not responded to standard treatments or have no standard treatments available.You need to have a medical condition that can be measured using specific guidelines called RECIST version 1.1.You must be a man or a woman who is 18 years old or older.Your kidneys must be working well, which means that your blood creatinine level should be below 1.2 mg/dL. If it's higher than that, a special calculation will be used to determine if your kidneys are functioning well enough for the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B
- Group 2: Arm A
- Group 3: Arm C
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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