Temozolomide for Gastrointestinal Stromal Tumor
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether the drug Temozolomide can effectively treat a specific kind of stomach cancer called SDH-Mutant/Deficient Gastrointestinal Stromal Tumor. This cancer type does not respond well to current treatments, so researchers aim to determine if Temozolomide, typically used for certain brain cancers, might be beneficial. Suitable candidates for this trial include individuals whose stomach cancer is confirmed to have this SDH mutation and who are not currently undergoing other cancer treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering a chance to benefit from a potentially effective new therapy.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot be on other cancer treatments like chemotherapy or targeted therapy when starting the study. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that Temozolomide is likely to be safe for humans?
Research has shown that the drug temozolomide (TMZ) could help treat a specific type of gastrointestinal tumor called SDH-mutant/deficient GIST. Although the FDA has approved temozolomide for some brain cancers, it is still under investigation for this type of tumor.
Earlier studies found that temozolomide had positive effects in a small number of patients with this condition, suggesting it might be a good option for those whose tumors don't respond to other treatments.
Regarding safety, temozolomide is usually well-tolerated in its approved uses. Patients should expect regular check-ups to monitor for any side effects during treatment. If side effects occur, the dosage might be adjusted to ensure the treatment remains as safe as possible for participants.12345Why do researchers think this study treatment might be promising for GIST?
Unlike the standard treatments for gastrointestinal stromal tumors, which often include drugs like imatinib and sunitinib, Temozolomide offers a unique approach. It is administered orally in a cyclical pattern, which may provide a more convenient treatment option compared to some existing therapies that require regular injections or infusions. Researchers are excited about its potential because it might offer benefits to patients who haven't responded well to current treatments, bringing new hope for those with limited options. Additionally, Temozolomide's schedule allows for regular breaks, which might help in managing side effects more effectively.
What evidence suggests that Temozolomide might be an effective treatment for SDH-Mutant/Deficient Gastrointestinal Stromal Tumor?
Research has shown that the drug Temozolomide (TMZ) might help treat a rare type of tumor in the digestive system called SDH-deficient gastrointestinal stromal tumors (GISTs). In one retrospective study, 2 out of 5 patients experienced tumor shrinkage after using this treatment. Another study found that Temozolomide benefited patients with GISTs who did not respond to other treatments. Although the FDA has not officially approved Temozolomide for this specific type of GIST, these findings suggest it could be beneficial for patients with this rare tumor. Participants in this trial will receive Temozolomide at a dose of 85 mg/m2 orally for 21 days, followed by 7 days without treatment, in 28-day cycles.12467
Who Is on the Research Team?
Jason Sicklick, MD
Principal Investigator
University of California, San Diego
Adam Burgoyne, MD
Principal Investigator
University of California, San Diego
Are You a Good Fit for This Trial?
This trial is for male and female patients with a specific type of cancer called SDH-Mutant/Deficient Gastrointestinal Stromal Tumor (GIST) that cannot be removed by surgery or has spread. Participants must have recovered from previous treatments, not have severe diseases like uncontrolled heart conditions, and agree to use contraception. Pregnant or breastfeeding women and those unable to take oral medication are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Temozolomide (TMZ) 85 mg/m2 orally for 21 days followed by 7 days without treatment in 28-day cycles, continuing for 6 months or until disease progression or unacceptable toxicity
End of Treatment
An end of treatment visit for clinical evaluations and safety assessments approximately 28 days after the last dose of study drug
Follow-up
Participants are monitored for disease recurrence and survival every 3-6 months
What Are the Treatments Tested in This Trial?
Interventions
- Temozolomide
Temozolomide is already approved in European Union, United States for the following indications:
- Newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and subsequently as monotherapy treatment
- Children from the age of three years, adolescents and adults with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy
- Newly diagnosed glioblastoma concomitantly with radiotherapy and subsequently as monotherapy treatment
- Newly diagnosed or refractory anaplastic astrocytoma
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Who Is Running the Clinical Trial?
Adam Burgoyne, MD, PhD
Lead Sponsor