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Lorlatinib for Neuroblastoma
Study Summary
This trial is testing a new drug, called lorlatinib, to see if it is safe and effective in children with relapsed or refractory neuroblastoma. This is a Phase I trial, which means that the goal is to find the best dose of the drug to give. The trial will first test the drug in a small group of patients to see if it is safe. If it is, then the trial will move on to testing different doses of the drug in a larger group of patients.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 1 trial • 29 Patients • NCT03542305Trial Design
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Who is running the clinical trial?
Media Library
- I do not have any ongoing or uncontrolled infections.My neuroblastoma has come back, is not responding, or hasn't gone away.I am expected to live at least 12 weeks and can do some daily activities on my own.I have thought about suicide recently and have attempted it before.I have been diagnosed with neuroblastoma confirmed by tests.My neuroblastoma is classified as high-risk.My neuroblastoma cancer has spread to my bone marrow.I have chosen not to participate in the NANT 2004-05 study.My tumor has an ALK mutation confirmed by a certified test.I have recovered from side effects of my previous cancer treatments.I have had a stem cell transplant from a donor.My major organs are healthy enough to handle treatment.I have a history of HIV, hepatitis B, or hepatitis C.I have a lesion that tested positive for neuroblastoma or ganglioneuroblastoma.I am currently receiving hemodialysis.I have a tumor that can be measured.My organs are functioning well.
- Group 1: Cohort B2 (Combined w/ chemotherapy)
- Group 2: Cohort A2 (Adult and large BSA)
- Group 3: Cohort A1 (Dose-finding)
- Group 4: Cohort B1 (Expansion)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any North American locations that are running this clinical experiment?
"As of now, 13 medical facilities are offering this trial. These include Children Hospital of Colorado in Aurora, Children's Hospital Los Angeles in Los Angeles and the renowned Children's Healthcare of Atlanta located in Atlanta."
What are the main aims of this experimental investigation?
"This clinical trial will be measuring the primary outcome, MTD/RP2D determination A1 across a three day period. Secondary objectives include evaluating bone response with MIBG scans and FDG-PET scans following Curie scoring criteria, determining marrow response through morphological and immunohistologic evaluation of bilaterally obtained samples, as well as assessing overall responses according to NANT Response Criteria Version 2.0 definitions in order to determine complete or partial responders."
To what extent is Lorlatinib detrimental to one's health?
"Lorlatinib's safety rating, on a 1-3 scale, is determined to be at the lower end of that range due to there being minimal clinical data pertaining to its efficacy or harm."
Is there availability for participants in this trial currently?
"As per the data hosted on clinicaltrials.gov, this medical trial is still open for enrollment. This research was first posted in September of 2017 and has recently been updated as of May 5th 2022."
Would I be able to participate in this research initiative?
"This trial is looking to recruit 65 people between the ages of one and 99 who have already been diagnosed with neuroblastoma. Additionally, potential participants must meet size criteria (lesions ≥ 10 mm or lymph nodes ≥ 15mm), possess an activating ALK mutation or amplification (>10 signals) and/or a fusion protein arising from chromosomal translocation, be classified as high-risk according to COG risk classification at registration time, present with recurrent/progressive disease after diagnosis; refractory disease with no response/stable disease since diagnosis; persistent disease without partial response since diagnosis; MIBG avid bone site(s); FD"
How many individuals are currently involved in this experiment?
"Absolutely, according to the clinicaltrials.gov website, this trial is actively pursuing participants and began on September 5th 2017 with its latest update being recorded in May 2022. The medical study requires 65 patients from 13 sites for their research."
Has Lorlatinib been subjected to any other scientific research?
"Lorlatinib was first studied by City of Hope Comprehensive Cancer Center over two decades ago. Currently, there are a total 1225 completed trials and 868 active studies being conducted across the world, with numerous happening in Aurora, Colorado."
What pathologies are commonly remediated by Lorlatinib?
"Lorlatinib is the go-to treatment for malignant neoplasms, but has been found to assist with other afflictions such as multiple sclerosis, leukemia, myelocytic and acute sarcoma."
Is this experiment allowing participants aged 20 and above to join?
"The research requirements state that prospective participants must be between one and ninety-nine years old. Per the database, there are 454 trials for minors and 703 studies available to those above 65."
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