Study on Ivosidenib for Treating Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders with IDH1 Mutations in Children and Young Adults
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04195555
This clinical trial is testing the effectiveness of the drug ivosidenib in treating children and young adults with advanced solid tumors, lymphomas, or histiocytic disorders that have specific genetic changes called IDH1 mutations. The study aims to see if ivosidenib can help shrink tumors that have not responded to previous treatments or have returned after treatment.
Patient Parameters
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Program Overview
This study is part of the Pediatric MATCH trial and focuses on how well the drug ivosidenib works in treating children and young adults with advanced solid tumors, including brain tumors, lymphomas, and histiocytic disorders that have specific genetic changes known as IDH1 mutations. Ivosidenib may help stop the growth of cancer cells with these genetic changes. The trial will assess the drug's ability to shrink tumors and its safety in young patients.
Description
The main goal of this study is to determine how well ivosidenib works in shrinking tumors in children and young adults with advanced cancers that have IDH1 mutations. Researchers will also look at how long patients can live without the cancer getting worse and how well patients tolerate the drug. Additionally, the study will explore how the drug is processed in the body and how it affects the cancer cells.
Participants will take ivosidenib by mouth once a day. Treatment cycles last 28 days and can continue for up to 2 years unless the cancer progresses or side effects become unacceptable. After finishing the treatment, patients will have regular follow-up visits to monitor their health.
Eligibility Criteria
Inclusion Criteria
- Must be enrolled in the Pediatric MATCH trial and assigned to this study based on having an IDH1 mutation.
- Aged between 12 months and 21 years.
- Must have a body surface area of at least 0.78 m².
- Must be able to swallow tablets whole.
- Must have measurable disease on scans or specific evaluable disease for neuroblastoma.
- Must have a performance status score of at least 50%.
- Must have recovered from previous cancer treatments and meet specific timeframes since last treatment.
- Must not have received ivosidenib or other IDH1 inhibitors before.
- Must have adequate blood counts and organ function as determined by specific tests.
- Must not have uncontrolled seizures and must be on stable anticonvulsant medication if applicable.
- Must provide informed consent from parents or legal guardians, and assent from the patient if appropriate.
Exclusion Criteria
- Pregnant or breastfeeding individuals cannot participate.
- Must agree to use effective non-hormonal birth control during and after the study.
- Cannot be on unstable doses of corticosteroids.
- Cannot be taking other investigational drugs or anti-cancer agents.
- Cannot be on medications to prevent graft-versus-host disease.
- Cannot be taking certain medications that affect how ivosidenib works.
- Cannot have a history of certain brain infections or uncontrolled infections.
- Cannot have had a solid organ transplant.
- Must be able to comply with study requirements according to the investigator's judgment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital of Alabama | 35233 | Birmingham | Alabama |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Banner Children's at Desert | 85202 | Mesa | Arizona |
| Phoenix Childrens Hospital | 85016 | Phoenix | Arizona |
| Banner University Medical Center - Tucson | 85719 | Tucson | Arizona |
| Arkansas Children's Hospital | 72202-3591 | Little Rock | Arkansas |
| Kaiser Permanente Downey Medical Center | 90242 | Downey | California |
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| Loma Linda University Medical Center | 92354 | Loma Linda | California |
| Miller Children's and Women's Hospital Long Beach | 90806 | Long Beach | California |
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