The Efficacy and Safety of Temozolomide in SDH-deficient GIST

NCT05661643 | Recruiting Phase 2

• 1 other identifier: AMC2203
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the efficacy and safety of temozolomide in SDH deficiency GIST patients.

Conditions

Gastrointestinal Stromal Tumors

Outcome Measures

Primary Outcomes (1)

• Objective respone rate in SDH deficiency wild type GIST

  complet response+partial response defined by RECIST v1.1

  up to 4 years

Study Arms (1)

temozolomide treatment

EXPERIMENTAL

Drug: Temozolomide capsule

Interventions

Temozolomide capsule DRUG

Temozolomide 200 mg/m2 is administered orally for 1-5 days of each cycle, and then canceled for 23 days (a total of 28 days is 1 cycle)

temozolomide treatment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20 years or older, at the time of acquisition of informed consent
• Histologically confirmed GIST with CD117(+), DOG-1(+)
• Wild type GIST without KIT or PDGFRα gene mutations determined by Sanger sequencing and panel sequencing
• Eastern Cooperative Oncology Group (ECOG) performance status 0 \~ 2
• Resolution of all adverse events with prior treatments to grade 0 or 1 by NCI-CTCAE version 5.0
• At least one measurable lesion by RECIST version 1.1.
• 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
• Life expectancy ≥12 weeks
• Disease progression or discontinuation of treatment due to intolerable toxicity at least with palliative 1st line imatinib .

You may not qualify if:

• Confirmed GIST with KIT or PDGFRα gene mutations determined by Sanger sequencing and panel sequencing
• Women of child-bearing potential who are pregnant or breast feeding
• 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
• 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
• Uncontrolled infection
• Acute and chronic liver disease and all chronic liver impairment.(But Patients with stable chronic hepatitis B are eligible
• 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
• Known diagnosis of HIV infection (HIV testing is not mandatory).
• History of another primary malignancy that is currently clinically significant or currently requires active intervention.
• Alcohol or substance abuse disorder
• The patients with NTRK fusion

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center, University of Ulsan College of Medicine

Seoul, 138-736, South Korea

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Min-Hee Ryu, MD, PhD

CONTACT

82-2-3010-5936; miniryu@amc.seoul.kr

Hyung-Don Kim, MD, PhD

CONTACT

82-2-3010-0236; kimhdmd@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: December 22, 2022
• Study Start: June 28, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

KR (1)