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ACTIVE NOT RECRUITING
NCT03556384
PHASE2

Temozolomide (TMZ) in Advanced Succinate Dehydrogenase (SDH)-Mutant/Deficient Gastrointestinal Stromal Tumor (GIST)

Sponsor: Adam Burgoyne, MD, PhD

View on ClinicalTrials.gov

Summary

Funding Source - FDA OOPD FDA-approved products for patients with unresectable or metastatic GIST include therapies such as imatinib and sunitinib. Although there are FDA-approved products for the treatment of advanced/metastatic GIST, these therapies are known to be ineffective in the SDH-mutant/deficient subtype and no known effective therapies exist. The purpose of this study is to investigate SDH-Mutant/Deficient Gastrointestinal Stromal cancer's response to the drug Temozolomide (TMZ) and aim to improve patient outcomes. Temozolomide is approved by the FDA for the treatment of newly diagnosed glioblastoma multiforme (GBM) and refractory anaplastic astrocytoma cancers. Temozolomide is considered experimental because it is not approved by the FDA for the treatment of SDH-Mutant/Deficient Gastrointestinal Stromal Tumor.

Official title: An Open-Label, Phase 2 Efficacy Study of Temozolomide (TMZ) in Advanced Succinate Dehydrogenase (SDH)-Mutant/Deficient Gastrointestinal Stromal Tumor (GIST)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

23

Start Date

2018-09-12

Completion Date

2026-06

Last Updated

2024-11-04

Healthy Volunteers

No

Interventions

DRUG

Temozolomide

Temozolomide 85 mg/m2 will be administered orally for 21 days followed by 7 days without treatment in 28 day cycles. Treatment will continue for 6 months (with option to continue if benefiting treatment) or until disease progression or unacceptable toxicity (whichever occurs first). All patients will have regular evaluations for assessment of safety parameters

Locations (4)

UC San Diego Moores Cancer Center

La Jolla, California, United States

University of Miami

Miami, Florida, United States

Oregon Health & Science University

Portland, Oregon, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States