Temozolomide for treating SDH-deficient gastrointestinal stromal tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of temozolomide, an alkylating agent, in patients with SDH-deficient gastrointestinal stromal tumors (GIST). Given the limited response of these tumors to standard treatments like imatinib, the study seeks to determine if temozolomide can effectively promote tumor cell death. The trial will include patients with histologically confirmed GIST and will assess treatment outcomes based on measurable lesions. Additionally, it will explore the drug's effects on KIT and PDGFRA wild-type GISTs without SDH deficiency.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 20 years or older, at the time of acquisition of informed consent
2. Histologically confirmed GIST with CD117(+), DOG-1(+)
3. Wild type GIST without KIT or PDGFRα gene mutations determined by Sanger sequencing and panel sequencing
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 \~ 2
5. Resolution of all adverse events with prior treatments to grade 0 or 1 by NCI-CTCAE version 5.0
6. At least one measurable lesion by RECIST version 1.1.
7. Adequate bone marrow, hepatic, renal, and other organ functions, before adjuvant imatinib treatment

   * Neutrophil \>1,500/mm3
   * Platelet \> 100,000/mm3
   * Hemoglobin \>8.0 g/dL
   * Total bilirubin \< 1.5 x upper limit of normal (ULN)
   * AST/ALT \< 2.5 x ULN
   * Creatinine \<1.5 x ULN
8. Life expectancy ≥12 weeks
9. Disease progression or discontinuation of treatment due to intolerable toxicity at least with palliative 1st line imatinib .
10. Washout period of previous TKIs or chemotherapy for more than 4 times the half life ((Imitinib and regorafenib need 1 week and sunitinib need 2 weeks.)
11. Provision of a signed written informed consent

Exclusion Criteria:

1. Confirmed GIST with KIT or PDGFRα gene mutations determined by Sanger sequencing and panel sequencing
2. Women of child-bearing potential who are pregnant or breast feeding
3. Women or men who are not willing to use effective contraception entering the study period or until at least 6 months after the last study drug administration
4. If any of the following applies within ≤ 6 months prior to starting study enrollment : Myocardial Infarction, severe instable angina, coronary/peripheral bypass, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, treatment required severe arrhythmia
5. Uncontrolled infection
6. Acute and chronic liver disease and all chronic liver impairment.(But Patients with stable chronic hepatitis B are eligible
7. Acute, or chronic medical or psychiatric condition or laboratory abnormality such as active uncontrolled infection that difficult to study participation in the judgment of the investigator
8. Known diagnosis of HIV infection (HIV testing is not mandatory).
9. History of another primary malignancy that is currently clinically significant or currently requires active intervention.
10. Alcohol or substance abuse disorder
11. The patients with NTRK fusion

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Where it's running

• Asan Medical Center, University of Ulsan College of Medicine
  Seoul, Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Min-Hee Ryu, MD, PhD
• Email: miniryu@amc.seoul.kr
• Phone: 82-2-3010-5936

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• DCC-2618 in GIST after at least 3 prior treatments

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• Understanding genetic causes of neuroendocrine tumors in Mexican patients

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• Combining radiotherapy with ripretinib for advanced GIST treatment

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• Oral Liporaxel (paclitaxel) treatment for gastrointestinal stromal tumors

  This study will test whether taking oral Liporaxel (a form of paclitaxel) can help people with advanced GIST who stopped responding to imatinib, sunitinib, and regorafenib and whose tumors have low P‑glycoprotein levels.

  Recruiting Phase 2 Asan Medical Center · Seoul, Songpagu · NCT06326346

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.