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Temozolomide for Gastrointestinal Stromal Tumor
Study Summary
This trial is investigating if the drug Temozolomide can be an effective treatment for SDH-Mutant/Deficient Gastrointestinal Stromal Tumor, which currently doesn't have any known effective treatments.
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.Side effects data
From 2016 Phase 2 trial • 175 Patients • NCT01055314Trial Design
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Who is running the clinical trial?
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- I agree to use contraception during and up to 120 days after the study.I am a woman who can have children and have a recent negative pregnancy test.My GIST is confirmed to have an SDH mutation.I have not had major surgery in the last 4 weeks.I do not have severe or uncontrolled health issues like heart or lung problems.I cannot swallow pills.I have recovered from the side effects of my previous cancer treatments.I can take care of myself and am up and about more than half of the day.My blood, liver, and kidney functions are all within normal ranges.I am not on any cancer treatments like chemotherapy or immunotherapy when starting this study.I do not have brain metastases.I agree to follow strict birth control measures or abstain from sex during and 120 days after the study.I do not have any uncontrolled conditions like infections, diabetes, or heart disease.I have severe heart issues or had a recent heart attack.I don't have severe side effects from past cancer treatments, except for hair loss.
- Group 1: TMZ 85 mg/m2 mg orally
- 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
To what extent are hospitals participating in this trial?
"Presently, there are 4 sites running this experiment: Miami, Philadelphia and La Jolla plus an additional 4. It is prudent to select the closest locale to you in order to limit transit needs should you join."
Are there any vacancies for individuals to participate in this clinical trial?
"The information available on clinicaltrials.gov indicates that recruitment for this trial is ongoing, as it was first posted in September 2018 and most recently updated at the end of 2022."
Has there ever been a similar experiment to this one?
"Temozolomide has seen extensive scientific exploration since its initial clinical trial, sponsored by Schering-Plough in 2002. This first study involving 60 participants paved the way for Phase 2 drug approval and now there are 207 active studies taking place across 935 cities and 36 countries."
In what conditions is Temozolomide typically prescribed?
"Refractory, advanced mycosis fungoides can be treated with Temozolomide in combination with nitrosourea treatment and advance directives."
Has the Temozolomide drug been given clearance by the Food and Drug Administration?
"Our evaluation of temozolomide, considering it is a Phase 2 trial lacking efficacy data, was that its safety merits a score of two."
To what extent have other researchers explored the efficacy of Temozolomide?
"Presently, 207 studies are underway to investigate the effects of Temozolomide. Of these, 24 live clinical trials have reached phase 3. Seoul Songpa is home to the bulk of these research endeavors; however, there are 4752 locations conducting this trial globally."
How many individuals have enrolled to participate in this experiment?
"23 individuals that meet the prerequisites are being sought to be part of this medical trial. These participants can attend from two locations, one in Miami, Florida and another at Fox Chase Cancer Center situated in Philadelphia, Pennsylvania."
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