Study on Olutasidenib and Temozolomide for High-Grade Glioma in Children and Young Adults
Sponsor: Rigel Pharmaceuticals
ClinicalTrials ID:NCT06161974
This clinical trial is testing whether the combination of the drugs olutasidenib and temozolomide can help extend the lives of children and young adults newly diagnosed with a high-grade glioma (HGG) that has a specific IDH1 mutation.
Patient Parameters
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Program Overview
The purpose of this study is to find out if the drug olutasidenib, when used with temozolomide, can effectively treat children and young adults who have been newly diagnosed with a high-grade glioma (HGG) that has an IDH1 mutation. The study will look at whether this combination can help patients live longer after their initial treatment with radiation therapy. Researchers will also study how well the drugs work together, any side effects, and how the body processes olutasidenib.
Description
This international study involves children and young adults who have recently been diagnosed with a high-grade glioma (HGG) that has an IDH1 mutation. After completing radiation therapy, participants will receive olutasidenib along with temozolomide for 13 cycles, followed by 13 cycles of olutasidenib alone. The study aims to determine if this treatment can help patients live longer without the cancer getting worse, compared to past patients with similar conditions. Researchers will also monitor how the tumors respond to the treatment, any side effects, and how the drug is absorbed and processed in the body.
Eligibility Criteria
Inclusion Criteria
- Age between 12 and 39 years old.
- Newly diagnosed with high-grade glioma (HGG) with an IDH1 mutation, including DIPG.
- Must have tumor tissue from a biopsy or surgery.
- No need for measurable disease; patients without measurable disease are eligible.
- No metastatic disease.
- Must have a specific mutation in the IDH1 gene.
- Good overall health with a performance score of 50% or higher.
- Previous treatments like surgery, radiation, and certain medications are allowed.
- Must have started radiation therapy within 31 days of diagnosis.
- Must begin study treatment within 21 to 35 days after finishing radiation therapy.
- Adequate bone marrow, kidney, and liver function as shown by specific blood tests.
- Must provide informed consent to participate.
Exclusion Criteria
- Pregnant or breastfeeding women cannot participate.
- Participants must agree to use effective birth control during the study and for 3 months after.
- Cannot be taking certain medications that affect the study drugs.
- Cannot have uncontrolled infections or other serious health conditions.
- Cannot have a history of HIV, hepatitis B, or hepatitis C.
- Cannot have had a solid organ transplant.
- Cannot have secondary or radiation-related HGG.
- Cannot have metastatic HGG that has been treated with craniospinal irradiation (CSI).
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital Colorado | 80045 | Aurora | Colorado |
| Children's National Medical Center | 20010 | Washington | District of Columbia |
| Ann & Robert H. Lurie Children's Hospital of Chicago | 60611 | Chicago | Illinois |
| Susan Chi | 02215 | Boston | Massachusetts |
| Duke University Health System | 27708 | Durham | North Carolina |
| Cincinnati Children's Hospital Medical Center | 45229 | Cincinnati | Ohio |
| Nationwide Children's Hospital | 43235 | Columbus | Ohio |
| Children's Hospital of Philadelphia | 19104 | Philadelphia | Pennsylvania |
| Texas Children's Hospital | 77030 | Houston | Texas |
| Seattle Children's Hospital | 98105 | Seattle | Washington |
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