The Efficacy and Safety of Temozolomide in SDH-deficient GIST

Launched by ASAN MEDICAL CENTER · Dec 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a medication called temozolomide for patients with gastrointestinal stromal tumors (GIST) that have a specific genetic condition known as SDH deficiency. The trial is currently recruiting participants who are 20 years and older and have been diagnosed with GIST. To be eligible, individuals must have tumors that do not have certain genetic mutations and must show that they have at least one measurable tumor.

Participants in this study can expect to receive temozolomide and will be monitored closely for how well the treatment works and any side effects. It’s important for potential participants to be in generally good health, with stable organ function and a life expectancy of at least 12 weeks. Those with certain health conditions, recent heart issues, or other significant medical concerns may not be eligible. Before joining, individuals will need to provide written consent to participate in the study.

Gender

ALL

Eligibility criteria

• 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
• • 5)