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Immunomodulatory Drug
Lenalidomide Dosing for Brain Tumor
Phase 2
Waitlist Available
Led By Katherine E Warren
Research Sponsored by National Cancer Institute (NCI)
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 up to 180 days after enrollment
Awards & highlights
No Placebo-Only Group
Summary
This trial is comparing two different doses of lenalidomide to see which is more effective in treating juvenile pilocytic astrocytomas or optic nerve pathway gliomas.
Who is the study for?
This trial is for young patients with recurrent, refractory, or progressive pilocytic astrocytoma or optic pathway glioma. They must have had prior carboplatin treatment and be able to swallow capsules. Pregnant or breastfeeding females can't join; others must use strict birth control. Patients need a minimum body surface area, specific blood counts, organ function levels, and no uncontrolled infections or significant systemic illnesses.
What is being tested?
The study compares low-dose versus high-dose Lenalidomide in treating juvenile brain tumors that are growing despite previous treatments. Lenalidomide aims to boost the immune system and may hinder tumor growth by cutting off its blood supply. The effectiveness of different doses is being evaluated.
What are the potential side effects?
Lenalidomide might cause side effects like blood clots unrelated to central lines, increased risk of infection due to lowered immunity, potential impact on liver enzymes leading to liver issues, fatigue from anemia (low red blood cell count), and possibly other unknown risks due to its action on the immune system.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 180 days after enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 180 days after enrollment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Patients Who Demonstrate Complete or Partial Response
Number of Patients Who Demonstrate Early Progression
Secondary study objectives
Event-free Survival [EFS]
Magnetic Resonance Imaging Sequence
Number of Patients With Toxic Events After 2 Dose Reductions
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (high-dose lenalidomide)Experimental Treatment2 Interventions
Patients receive high-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (low-dose lenalidomide)Experimental Treatment2 Interventions
Patients receive low-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~2240
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,938 Previous Clinical Trials
41,023,095 Total Patients Enrolled
3 Trials studying Neurofibromatosis
290 Patients Enrolled for Neurofibromatosis
Katherine E WarrenPrincipal InvestigatorChildren's Oncology Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must have a body surface area (BSA) of at least 0.4 square meters when you join the study.If you have a history of spinal or leptomeningeal disease, or if you have symptoms that suggest spinal disease, you need to have a spine MRI with and without contrast (gadolinium) done within 2 weeks before joining the study.You have already been treated with a medication containing carboplatin or have received radiation therapy for this tumor.You have a history of blood clots not related to a central line, or you have a condition that makes you more likely to develop blood clots.Your hemoglobin level is at least 8.0 grams per deciliter. If it's lower, you may need a red blood cell transfusion.Your SGPT (ALT) level in the blood should be no higher than 110 U/L, and for this study, the normal upper limit for SGPT is 45 U/L.Your blood protein level (serum albumin) is at least 2 grams per deciliter.You are not having trouble breathing while resting, and your pulse oximeter shows oxygen levels above 94% if your doctor checks it.You must have a good score on a test that measures how well you can do daily activities.You must have recovered from the side effects of any previous chemotherapy, immunotherapy, or radiotherapy before joining the study, except for hair loss, minor weight changes, and certain low levels of white blood cells.Your kidneys work well enough based on a test called creatinine clearance or GFR, or a blood test called serum creatinine.You have enough white blood cells called neutrophils in your blood.Your total bilirubin level is not more than 1.5 times the upper limit of normal for your age.Everyone needs to have a brain MRI scan with and without contrast (dye) within 1 week before joining the study. If you are taking steroids, the MRI must be done after at least 1 week on a stable or lower dose of steroids.Your platelet count is at least 100,000 per microliter and you don't need blood transfusions for it.You need to have a biopsy confirming cancer, except for patients with optic pathway gliomas.You have a history of serious heart problems like heart attack, severe chest pain, or poorly controlled irregular heartbeats.You have a specific type of brain tumor called pilocytic astrocytoma or optic pathway glioma that has not responded to regular treatment, and you have neurofibromatosis (NF-1).Your tumor must be large enough to be seen and measured on a specific type of imaging called magnetic resonance imaging (MRI).
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (low-dose lenalidomide)
- Group 2: Arm II (high-dose lenalidomide)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.