TRIAL DETAIL

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

Drug:
Trial Name:
Temozolomide (TMZ) In Advanced Succinate Dehydrogenase (SDH)-Mutant/Deficient Gastrointestinal Stromal Tumor
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Recruiting
Phase:
2
Start Date 08/08/2018
Age of Trial (yrs) 1.1
Treatment Phase:
Gleevec-resistant
Drug Category:
SDH-directed
Strategy:
Interfere with DNA replication
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
180114
Sponsor:
Adam Burgoyne, MD, PhD UCSD
Patient Contact:
Adam M Burgoyne, MD, PhD(858) 822-3092 aburgoyne@ucsd.edu Jason Sicklick, MD 858-822-6173 jsicklick@ucsd.edu
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
Inclusion Criteria:

Patient has pathologically confirmed SDH-mutant/deficient GIST.
Brief Summary:

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.

Detailed Description:

This oncology study will be a phase 2 study for patients with advanced or metastatic GIST. This study will determine overall response rate at 6 months for TMZ therapy in patients with SDH-mutant/deficient GIST.

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. Temozolomide dose may be held and/or modified for the management of adverse treatment effects according to pre-specified criteria. Patients will have radiographic imaging (CT or MRI) every 8 weeks to assess tumor resection.

An end of treatment visit for clinical evaluations and safety assessments will be performed approximately 28 days (7 days) after the last dose of study drug. Patients discontinuing study treatment will be followed every 3-6 months for disease recurrence and survival.

Trial Links

 

Trial Results

Drug Information

Temodar prescribing information
 
Temozolomide - Wikipedia
 
NCI - Temozolomide
 
U.S. National Library of Medicine - Drug Info
 

Trial Sites

Name
Address
City
State
Zip
Country
La Jolla
CA
92093
USA