Ivosidenib for Advanced Solid Cancers, Lymphoma & Histiocytosis

Recruiting in Palo Alto (17 mi)

+183 other locations

Overseen byElizabeth D Alva

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II Pediatric MATCH trial studies how well ivosidenib works in treating patients with solid tumors that have spread to other places in the body (advanced), lymphoma, or histiocytic disorders that have IDH1 genetic alterations (mutations). Ivosidenib may block the growth of cancer cells that have specific genetic changes in an important signaling pathway called the IDH pathway.

Research Team

Elizabeth D Alva

Principal Investigator

Children's Oncology Group

Eligibility Criteria

This trial is for young patients aged between 12 months and 21 years with advanced solid tumors, lymphoma, or histiocytic disorders that have a specific genetic change (IDH1 mutation). They must be able to swallow tablets, have not used IDH1 inhibitors before, and meet certain health criteria like adequate blood counts and organ function. Pregnant individuals or those on certain medications are excluded.

Inclusion Criteria

My white blood cell count is healthy for cancer treatment.

I am between 12 and 21 years old.

I can swallow pills without any issues.

See 18 more

Exclusion Criteria

I am taking medication to prevent graft-versus-host disease after a bone marrow transplant.

I do not have any infections that are currently uncontrolled.

Pregnant or breast-feeding women

See 7 more

Treatment Details

Interventions

Ivosidenib (IDH1 Inhibitor)

Trial OverviewThe trial is testing Ivosidenib's effectiveness in treating cancers with IDH1 mutations. It's a phase II study focusing on whether this drug can stop cancer cells from growing by targeting the IDH pathway—a critical cell signaling route involved in tumor development.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (ivosidenib)Experimental Treatment1 Intervention

Patients receive ivosidenib PO QD. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.