Clinical research studies for children with advanced cancer
The LIGHTBEAM Studies are a group of clinical trialsClinical Study / Clinical TrialA research study designed to learn how our bodies respond to medicines, vaccines or other treatments; A way to study new medicines (vaccines), devices and treatments to see if they are safe and work in people; Compares a study treatment to another treatment or even no treatment (placebo); Research that studies people (called participants) to understand health and disease. Also called Clinical Study; trial; protocol; being done to learn more about different investigational study drugsInvestigational Medicine (Treatment)A treatment or medicine in a clinical study which is not yet approved [by health authorities or government agencies] for the condition being studied for children and young adults with advanced blood cancersCancerAbnormal cells that grow out of control [may invade other tissues and may spread into other parts of the body]; Also called malignancy. or solid tumorsTumorA mass or growth that forms in the body that can be cancer (malignant) or not cancer (benign). Also called neoplasm. Researchers want to study the safetySafe / SafetyAn assessment of the likelihood of causing an undesired effect, tolerabilityTolerability[A measurement of] How well people manage or handle the effects of a medicine, treatment, or vaccine, and effects of these investigational study drugs.
Each substudySubstudyResearch in a smaller group of participants in a clinical trial, who are included to find out answers to specific additional questions. below is looking at a different study drug for individuals with certain cancersCancerAbnormal cells that grow out of control [may invade other tissues and may spread into other parts of the body]; Also called malignancy.. Speak with your child’s doctor to see if your child may qualify to participate.
Substudy 01A
A clinical study looking at the safety, tolerability, and effects of an investigational study drug in children and young adults with B-cell acute lymphoblastic leukemia, diffuse large B-cell lymphoma, Burkitt lymphoma, neuroblastoma, or Ewing sarcoma
[View Trial Page]A clinical trialis a research study designed to learn how our bodies respond to investigational treatmentsInvestigational Medicine (Treatment)A treatment or medicine in a clinical study which is not yet approved [by health authorities or government agencies] for the condition being studied. Clinical trials help researchers learn whether investigational treatmentsTreatmentA medicine or therapy for a condition, illness or disease. Also called Therapy or new uses for existing treatments are safe and effective.
When considering a clinical studyClinical Study / Clinical TrialA research study designed to learn how our bodies respond to medicines, vaccines or other treatments; A way to study new medicines (vaccines), devices and treatments to see if they are safe and work in people; Compares a study treatment to another treatment or even no treatment (placebo); Research that studies people (called participants) to understand health and disease. Also called Clinical Study; trial; protocol; for your child, the first step is to make an informedInformed Consent ProcessThe process of discussing and learning about the details of a study [clinical trial] before deciding whether to participate; a process in which people (participants) are given important information, including possible risks and benefits, about a study (clinical trial) to help them decide if they want to participate in the trial; People are also given any new information that might affect their decision to continue decision about whether to participate.
Clinical studiesClinical Study / Clinical TrialA research study designed to learn how our bodies respond to medicines, vaccines or other treatments; A way to study new medicines (vaccines), devices and treatments to see if they are safe and work in people; Compares a study treatment to another treatment or even no treatment (placebo); Research that studies people (called participants) to understand health and disease. Also called Clinical Study; trial; protocol; go through several steps, or phases, each designed to answer certain questions about the investigational study drug and how it affects the body. In Phase 1 studiesPhase 1 clinical trialResearchers try to find a safe dose [of a treatment] for people with [a condition}, A study to find a safe dose of a treatment in healthy people, the investigational study drug is tested on a relatively small group of volunteers. In a pediatric oncology study, usually the investigational study drug has already been tested in adults. Participants are given a low dose of the investigational study drug to look at safetySafe / SafetyAn assessment of the likelihood of causing an undesired effect.
Phase 2 studiesPhase 2 clinical trialResearchers try to find out if a new treatment works in a small group of people test the investigational study drugInvestigational Medicine (Treatment)A treatment or medicine in a clinical study which is not yet approved [by health authorities or government agencies] for the condition being studied in a medium sized group of volunteers to learn if the investigational study drug may work and identify any new side effectsSide effectAn effect of a medicine, treatment or intervention that is additional to the main intended effect and can be good, bad or neutral; A health problem that is likely caused by an approved treatment.
People who participate in clinical studiesClinical Study / Clinical TrialA research study designed to learn how our bodies respond to medicines, vaccines or other treatments; A way to study new medicines (vaccines), devices and treatments to see if they are safe and work in people; Compares a study treatment to another treatment or even no treatment (placebo); Research that studies people (called participants) to understand health and disease. Also called Clinical Study; trial; protocol; are volunteers. Who can take part in a clinical study depends on the research question the study is trying to answer (what the study is being done for). Each study has a set of requirements that an individual must meet in order to participate. The study team will collect information about your child s health and run tests to see if your child qualifies for that study. You and your child must also give your permission before any tests or procedures can take place.
Informed consent is the process through which potential participants learn about a specific clinical studyClinical Study / Clinical TrialA research study designed to learn how our bodies respond to medicines, vaccines or other treatments; A way to study new medicines (vaccines), devices and treatments to see if they are safe and work in people; Compares a study treatment to another treatment or even no treatment (placebo); Research that studies people (called participants) to understand health and disease. Also called Clinical Study; trial; protocol;. The Informed Consent ProcessInformed Consent ProcessThe process of discussing and learning about the details of a study [clinical trial] before deciding whether to participate; a process in which people (participants) are given important information, including possible risks and benefits, about a study (clinical trial) to help them decide if they want to participate in the trial; People are also given any new information that might affect their decision to continue goes over the details of the study including the purpose, the investigational study drugInvestigational Medicine (Treatment)A treatment or medicine in a clinical study which is not yet approved [by health authorities or government agencies] for the condition being studied, visits, tests, and the potential benefits and risksRisks of a clinical trialThe possible disadvantages (problems or harm) of being in a clinical trial, such as side effects or taking time. If you are considering a clinical study, this process helps you make an informed decision about whether to participate. If you decide to join or have your child join, you will sign an Informed Consent FormInformed Consent form (IC)A document that provides information about the purpose of the study, possible risks and benefits, and the participant's rights and responsibilities. Signing the consent form means that the person agrees to participate in the research; A document used to explain the details of a study (clinical trial) before any study procedures can begin. Even after you give your consent, you and your child can still choose to leave the study at any time.
A study drug, or investigational drugInvestigational Medicine (Treatment)A treatment or medicine in a clinical study which is not yet approved [by health authorities or government agencies] for the condition being studied, is a drug that hasn’t yet been approved for use by the general public. To be approved, an investigational study drug must be tested in clinical studiesClinical Study / Clinical TrialA research study designed to learn how our bodies respond to medicines, vaccines or other treatments; A way to study new medicines (vaccines), devices and treatments to see if they are safe and work in people; Compares a study treatment to another treatment or even no treatment (placebo); Research that studies people (called participants) to understand health and disease. Also called Clinical Study; trial; protocol; to determine that it is safeSafe / SafetyAn assessment of the likelihood of causing an undesired effect and effective in treating the target disease in certain groups of people.
Side effectsSide effectAn effect of a medicine, treatment or intervention that is additional to the main intended effect and can be good, bad or neutral; A health problem that is likely caused by an approved treatment are any effects of a medicineDrug (or medicine, medication, treatment)Medicine being studied in the clinical trial; study medication; study treatment., treatment, or interventionInterventionAction; Treatment; A treatment given in a study other than the main intended effect, and could be good, bad, or neutral. Investigational medicinesInvestigational Medicine (Treatment)A treatment or medicine in a clinical study which is not yet approved [by health authorities or government agencies] for the condition being studied must be tested for side effects that happen right away or after a longer time.
All study medicineDrug (or medicine, medication, treatment)Medicine being studied in the clinical trial; study medication; study treatment. and study related tests will be provided at no cost. You or your insurance company may be responsible for the cost of tests or treatmentsTreatmentA medicine or therapy for a condition, illness or disease. Also called Therapy that are part of standard careStandard of care (Standard Treatment)Accepted or approved treatment for a condition (disease or illness); treatment usually given to people for a condition (disease or illness) at the time; the treatment for a condition that is accepted and widely used by health care professionals at the time used to maintain your child’s health, even if you did not take part in this study.
Participation in a clinical studyClinical Study / Clinical TrialA research study designed to learn how our bodies respond to medicines, vaccines or other treatments; A way to study new medicines (vaccines), devices and treatments to see if they are safe and work in people; Compares a study treatment to another treatment or even no treatment (placebo); Research that studies people (called participants) to understand health and disease. Also called Clinical Study; trial; protocol; is voluntary. You and your child can change your mind and leave the study at any time. Leaving the study will not affect your child’s regular medical care.
If you think one of the LIGHTBEAM Clinical StudiesClinical Study / Clinical TrialA research study designed to learn how our bodies respond to medicines, vaccines or other treatments; A way to study new medicines (vaccines), devices and treatments to see if they are safe and work in people; Compares a study treatment to another treatment or even no treatment (placebo); Research that studies people (called participants) to understand health and disease. Also called Clinical Study; trial; protocol; may be a good fit for your child, the first step will be to see if your child is eligible. The study doctor will help determine which study is the best fit. Contact the study team at [CONTACT INFO]
PlacebosPlaceboA look-alike substance that does not contain any actual [active] medicine (vaccine or treatment); Looks like the study medicine (vaccine) but has no actual study medicine (vaccine) in it; [Sometimes called a “sugar pill”]; Using a placebo helps researchers better understand the actual effects of a trial medicine (vaccine) are almost never used in place of treatment when a standard therapy exists.
The best way to know if you should consider having your child be in a clinical studyClinical Study / Clinical TrialA research study designed to learn how our bodies respond to medicines, vaccines or other treatments; A way to study new medicines (vaccines), devices and treatments to see if they are safe and work in people; Compares a study treatment to another treatment or even no treatment (placebo); Research that studies people (called participants) to understand health and disease. Also called Clinical Study; trial; protocol; is to talk to your child’s doctor and discuss all treatmentTreatmentA medicine or therapy for a condition, illness or disease. Also called Therapy options.
If you think one of these clinical trials might be a good fit and you are interested in taking part, take the next step to see if you are eligible.
Print this page with details about the trial or email it to your doctor to discuss the clinical trialClinical Study / Clinical TrialA research study designed to learn how our bodies respond to medicines, vaccines or other treatments; A way to study new medicines (vaccines), devices and treatments to see if they are safe and work in people; Compares a study treatment to another treatment or even no treatment (placebo); Research that studies people (called participants) to understand health and disease. Also called Clinical Study; trial; protocol; during your next visit.
If you are considering joining a clinical trialClinical Study / Clinical TrialA research study designed to learn how our bodies respond to medicines, vaccines or other treatments; A way to study new medicines (vaccines), devices and treatments to see if they are safe and work in people; Compares a study treatment to another treatment or even no treatment (placebo); Research that studies people (called participants) to understand health and disease. Also called Clinical Study; trial; protocol;, first learn as much as you can about:
Talk to your doctor about the clinical trial before you decide to join.
Read our “What to Consider” page for more questions to ask and think about
