← Back to Search

ALK Inhibitor

Lorlatinib Combination with BABY POG chemotherapy for Diffuse Intrinsic Pontine Glioma

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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease Control Rate
Number of participants with lorlatinib-related adverse events as assessed by CTCAE v5.0
Secondary outcome measures
Objective Response Rate (ORR) in HGG
Overall Survival (OS) in HGG
Progression-Free Survival in HGG

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
~440

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor
341 Previous Clinical Trials
5,220,491 Total Patients Enrolled
6 Trials studying Diffuse Intrinsic Pontine Glioma
809 Patients Enrolled for Diffuse Intrinsic Pontine Glioma
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,915,967 Total Patients Enrolled
1 Trials studying Diffuse Intrinsic Pontine Glioma
128 Patients Enrolled for Diffuse Intrinsic Pontine Glioma
Hamza Gorsi, MDStudy ChairChildren's Hospital of Michigan

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial include individuals aged 80 and above as participants?

"Individuals aged between 1 year and 21 years are eligible for enrollment in this clinical study. Notably, there exist a total of 148 trials tailored for those below the age of majority while an additional 614 cater to individuals above the age of retirement."

Answered by AI

Am I eligible to participate in this medical trial?

"Patients aged between 1 year and 21 years with diffuse intrinsic pontine glioma are sought for this research project, with a total of 15 participants being the target."

Answered by AI

Do multiple healthcare facilities in the area conduct this particular medical research study?

"Enrollment for this trial is open at Children's Hospital of Philadelphia in Philadelphia, Pennsylvania; Duke University Health System in Durham, North carolina; and The Hospital for Sick Children (SickKids) in Toronto, Ontario. Additionally, recruitment is ongoing at 17 other sites across various locations."

Answered by AI

Is this clinical trial currently accepting new participants?

"As per clinicaltrials.gov, the present status of this research trial does not involve patient recruitment. The study was initially published on 9/1/2024 and last revised on 3/20/2024. While enrollment is closed for this particular trial, it's noteworthy that there are currently 742 other trials open to participant enrollment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion
2024. "Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06333899.
All > Anaplastic Astrocytoma
~10 spots leftby Sep 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top