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Radiation and Temozolomide vs. PCV Chemotherapy for Brain Tumor
Study Summary
This trial is testing whether giving radiation therapy with temozolomide drugs is more effective in treating brain tumors than giving radiation with another type of drug.
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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- My tumor tissue has specific genetic changes known as 1p/9q co-deletion and IDH mutation.I was diagnosed with a brain tumor <= 3 months ago or had surgery for a low-grade glioma > 3 months ago without prior radiation or chemotherapy.I am of childbearing age and not willing to use birth control.I have a serious condition that weakens my immune system, not caused by steroids.I am HIV positive and currently on retroviral therapy.My brain tumor is grade II or III with specific genetic changes.My brain tumor is a mixed glioma with specific genetic features (1p and 19q co-deletion).My low-grade brain tumor is considered high-risk.My brain tumor is a mixed glioma with specific genetic deletions.My tumor has an IDH mutation.I have had radiation or chemotherapy for brain cancer before.I was diagnosed with my condition less than 3 months ago.I have had a heart attack in the last 6 months or need ongoing treatment for heart failure.I agree to provide tissue samples for review after my surgery.My tumor has specific genetic changes, 1p/19q co-deletion and IDH mutation.My tumor has a specific genetic feature (loss of parts of chromosomes 1p and 19q).I am not pregnant or have confirmed it with a test.I am willing to undergo tests, provide tissue samples, and return for follow-ups.I had surgery over 2 weeks ago and have recovered well.My tumor has an IDH mutation.I can take care of myself and perform daily activities.My tumor has a specific genetic feature (loss of 1p/19q).Your blood test results need to meet certain standards.My low-grade glioma is considered high risk due to certain characteristics.I do not have severe illnesses that would prevent me from joining the study.I have had hepatitis or am at high risk of its reactivation.I have not had another cancer besides this one in the last 5 years.
- Group 1: Arm A (RT, procarbazine, lomustine, vincristine)
- Group 2: Arm B (RT, temozolomide)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
For what other medical diagnoses is concomitant temozolomide (TMZ) usually prescribed?
"Stage III Hodgkin's disease is often treated with concomitant temozolomide (TMZ). This medication is also known to be effective in treating other conditions such as anaplastic astrocytoma, acquired immunodeficiency syndrome, and advanced thymoma."
Is it legal to take temozolomide (TMZ) alongside other medications?
"There is prior clinical data supporting the safety of combining temozolomide (TMZ) with other cancer treatments, so it received a score of 3."
How many people are participating in this research project?
"Yes, you are correct. The trial is currently ongoing and recruiting patients. According to the clinicaltrials.gov website, this study was originally posted on September 1st, 2009 and was last updated on March 22nd, 2022. They are looking for 360 patients across 100 different locations."
Are there any other ongoing trials that are also testing temozolomide (TMZ)?
"The first recorded clinical trial involving concomitant temozolomide (TMZ) was conducted in 2001 at the UCSF Helen Diller Family Comprehensive Cancer Center. As of now, 687 such trials have been completed with 460 more presently underway. Many of these active trials are based out of Peoria, Illinois."
Where are potential participants able to enroll in this research?
"This trial is currently taking place at 100 different medical centres around the world, some of which include OSF Saint Francis Medical Center in Peoria, Tom Baker Cancer Centre in Calgary, and Thomas Jefferson University Hospital in Philadelphia."
Are recruitment efforts for this research study ongoing?
"From what is available on clinicaltrials.gov, it appears that the research team is still enrolling patients for this study. The earliest posting date was September 1st 2009 with the latest update March 22nd 2022. They hope to have 360 people participate from 100 different locations."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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