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Lenalidomide Dosing for Brain Tumor
Study 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.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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).
- Group 1: Arm I (low-dose lenalidomide)
- Group 2: Arm II (high-dose lenalidomide)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What medical conditions has Lenalidomide been shown to ameliorate?
"Lenalidomide is the go-to treatment for multiple myeloma. It has also proven to be efficacious in treating relapsed and/or refractory lymphoma, chronic lymphocytic leukemia, as well as certain cancers that have been resistant to prior systemic chemotherapy protocols."
What is the ultimate goal of this medical experiment?
"The primary goal of this clinical trial, evaluated over 26 cycles of chemotherapy for up to 3 years after enrollment, is early progression. Secondary objectives include the Time to Treatment Failure (EFS) which gauges how long patients can go without disease relapse or a second malignant neoplasm; Magnetic Resonance Imaging Sequence that assesses response categories such as complete and partial responses; and Overall Survival [OS], measuring estimated survival time from study enrolment until death or last follow-up visit."
How many participants has this experiment been able to recruit?
"This medical trial has ceased its patient recruitment, having been initially posted on March 19th 2012 and last updated September 16th 2023. Fortunately, there are currently 1385 trials related to Watson Syndrome with open enrollment as well as 268 studies involving lenalidomide admitting participants."
What other research initiatives have documented the effects of Lenalidomide?
"Lenalidomide first went through clinical trials in 2004, administered by the Midwest Center for Hematology Oncology. Since then, 515 studies have been completed with another 268 currently being conducted across various locations - most notably Chicago, Illinois."
How many locales are presently included in this research program?
"This trial is currently being conducted at 100 centres across the United States, including Chicago, Madera and Minneapolis. It would be beneficial to select a location closest to you in order to limit any necessary travel for participation."
Can Lenalidomide be reliably administered without presenting a risk to users?
"Our analysts at Power gave Lenalidomide a safety score of 2 because the drug is currently undergoing Phase 2 trials, meaning there are clinical data demonstrating it's safe but not yet any information that confirms its efficacy."
Are there any prospects for people to join the trial at present?
"At present, this trial is not accepting any more candidates. It was first introduced on March 19th 2012 and last revised on September 16th 2022. Alternatively, there are 1385 trials for Watson Syndrome and 268 studies enrolling Lenalidomide already looking to recruit individuals."
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