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Tazemetostat for Solid Cancers and Lymphoma
Study Summary
This trial is studying how well tazemetostat works in treating patients with brain tumors, solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have come back or do not respond to treatment and have EZH2, SMARCB1, or SMARCA4 gene mutations.
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 2021 Phase 2 trial • 20 Patients • NCT03456726Trial Design
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Who is running the clinical trial?
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- My blood tests do not show signs of specific blood disorders.I do not have any infections that are currently uncontrolled.I have been on a stable or decreasing dose of corticosteroids for at least 7 days.I am not taking medication that strongly affects liver enzyme CYP3A4.My cancer can be seen and measured on scans, or if I have neuroblastoma, it shows up on special scans even if not measurable.My blood counts meet the required levels and I haven't needed platelet transfusions in the last week.My kidney function is normal or near normal.I have a history of T-lymphoblastic lymphoma or leukemia.I am enrolled in APEC1621SC and assigned to MATCH in APEC1621C due to an actionable mutation.I have never taken tazemetostat or similar medications.I can do most daily activities by myself, and if I have a brain tumor, my condition has been stable for the last week.I do not have severe low blood counts or a history of bone marrow cancer.I have recovered from side effects of my previous cancer treatments.Your bilirubin, SGPT (ALT), serum albumin, corrected QT (QTc) interval, and international normalized ratio (INR) need to be within certain levels.You are currently taking other medications for cancer.I have never had myeloid malignancies or myelodysplastic syndrome.I am taking medication to prevent graft-versus-host disease after a bone marrow transplant.You have had an organ transplant in the past.
- Group 1: Treatment (tazemetostat)
- 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
Who is eligible to sign up for this clinical trial?
"This research project seeks to enrol 20 children aged between 12 months and 21 years who have been diagnosed with rhabdoid tumour. In addition, the participants must satisfy numerous conditions: bone marrow infiltration except that detected by MIBG scan for neuroblastoma; malignant fluid accumulations (e.g., ascites or pleural effusions); inclusion in APEC1621SC and a designated therapy plan based on actionable mutations; lesions only identified through nuclear medicine studies aside from those concerning neuroblastoma; heightened tumor markers found within plasma samples or cerebrospinal fluid (CSF); previously irradiated areas not showing evident"
Does the research protocol include individuals aged fifty and older?
"Participants between the ages of 12 months and 21 years are welcome to partake in this study."
Can you provide an overview of the research that has been conducted with Tazemetostat?
"At the moment, 20 trials for Tazemetostat are in progress with two of them being classified as Phase 3. Marshfield, Wisconsin is one of 1302 locations where research on this medication is conducted."
Is this an original or unprecedented trial?
"Research on Tazemetostat began in 2015, spearheaded by Epizyme Inc. with a sample size of 250 participants. This initial study allowed for the drug to progress through Phase 2 and gain approval from respective medical boards. Currently, there are 20 live trials located across 21 countries and 533 cities worldwide researching this medication's efficacy."
What side effects have been associated with the use of Tazemetostat?
"The safety of Tazemetostat was evaluated and rated a 2, as this is currently in Phase 2 clinical trials. This suggests that there is evidence to support the drug's safety but no data validating its efficacy yet."
How many participants are the researchers accepting into this trial?
"Unfortunately, no participants are currently being sought for this study. The trial was first posted on July 24th 2017 and last updated November 16th 2022. For those searching other trials, there is a total of 5678 clinical studies recruiting patients afflicted with rhabdoid tumor and 20 investigations seeking enrollees to be administered Tazemetostat."
At how many outposts is this investigation obtainable?
"This clinical trial is occurring in 100 different medical facilities, including the University of Wisconsin Hospital and Clinics in Madison, Ascension Saint Vincent Indianapolis Hospital in Indianapolis, and Children's Hospital and Medical Center of Omaha in Omaha."
Is this experiment actively seeking participants at the moment?
"This trial has now closed its recruitment window, having first been posted on July 24th 2017 and most recently updated November 16th 2022. However, if you are seeking another clinical study to join there are 5678 studies looking for rhabdoid tumour patients and a further 20 trials recruiting participants who will be treated with Tazemetostat."
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