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CTO + Temodar® for Glioblastoma
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.You have seizures that are not being controlled by medication.You have a medical condition that increases your risk of bleeding.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 already tried other cancer treatments or are not able to receive standard treatments like surgery or medication.You have a mental health condition that could affect your ability to understand the study and follow its rules.You have a medical condition that puts you at a higher risk of bleeding.You have a mental health condition that may affect your ability to understand and follow the study instructions.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.
- Group 1: Arm A
- Group 2: Arm B
- Group 3: Arm C
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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