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ALK Inhibitor

Lorlatinib for Brain Tumors

Phase < 1

Waitlist Available

Led By Maryam Fouladi, MD

Research Sponsored by Nationwide Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date on treatment until date of progressive disease or death due to any cause or date of last follow-up, assessed up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see how well the drug loratinib works in treating children with a specific type of brain tumor called high-grade glioma. The study will also look at the safety of using lor

Who is the study for?

This trial is for children newly diagnosed with high-grade gliomas, a type of brain tumor, that have specific genetic changes called ALK or ROS1 fusion. The exact eligibility criteria are not provided but typically include factors like age, health status, and the specifics of their cancer diagnosis.

What is being tested?

The study is testing lorlatinib's effectiveness on these brain tumors when given alone, alongside two different chemotherapy regimens (chemotherapy 1 and chemotherapy 2), or after radiation therapy. It aims to find out how well it works and its safety in these various combinations.

What are the potential side effects?

While specific side effects are not listed here, lorlatinib may commonly cause issues such as swelling in hands/feet, mood changes, weight gain or loss; less common but more serious side effects might include lung problems or liver damage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date on treatment until date of progressive disease or death due to any cause or date of last follow-up, assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date on treatment until date of progressive disease or death due to any cause or date of last follow-up, assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date on treatment until date of progressive disease or death due to any cause or date of last follow-up, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease Control Rate

Number of participants with lorlatinib-related adverse events as assessed by CTCAE v5.0

Secondary study objectives

Objective Response Rate (ORR) in HGG

Overall Survival (OS) in HGG

Progression-Free Survival in HGG

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Lorlatinib MonotherapyExperimental Treatment1 Intervention

Lorlatinib administered as monotherapy by PO (per os) or NG (nasogastric) for two 28-day cycles at 115 mg/m2/day (or maximum 200mg/dose), after which disease evaluation by Magnetic Resonance Imaging (MRI) imaging will be performed.

Group II: Lorlatinib Maintenance Therapy post RTExperimental Treatment2 Interventions

Lorlatinib monotherapy x2 cycles followed by Radiation Therapy and continue lorlatnib maintenance monotherapy (115 mg/m2/day) 28 days post completion of RT for 12 cycles

Group III: Lorlatinib Combination with HIT-SKK chemotherapyExperimental Treatment2 Interventions

Lorlatinib monotherapy x2 cycles followed by maintenance therapy with lorlatinib (115 mg/m2/day) and HIT-SKK chemotherapy backbone (cyclophosphamide, vincristine, methotrexate, carboplatin, etposide) The recommended HIT-SKK chemotherapy backbone regimen consists of modular chemotherapy cycles, three courses of 4 blocks each (Element IIS, Element IIIS/1, Element IIIS/2, and Element IVS). Each element will be administered consecutively at 2-3-week intervals. Elements IIS and IVS cycles will be repeated twice thereafter. The entire length of treatment for HIT-SKK will be approximately 42 weeks.

Group IV: Lorlatinib Combination with BABY POG chemotherapyExperimental Treatment2 Interventions

Lorlatinib monotherapy x2 cycles followed by maintenance therapy with lorlatinib (115 mg/m2/day) and BABY-POG chemotherapy backbone (vincristine, cyclophosphamide, cisplatin) The BABYPOG chemotherapy backbone regimen will consist of six 12-week courses. Each course will consist of cycles A, A2 and B, which will be administered consecutively, in 28-day cycles for a total of 72 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lorlatinib

2018

Completed Phase 4

~640

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