Tazemetostat in Malignant Peripheral Nerve Sheath Tumors
United States10 participantsStarted 2021-08-25
Plain-language summary
This phase 2, open label, single arm study will investigate the use of tazemetostat in patients with recurrent/refractory and/or metastatic malignant peripheral nerve sheath tumors.
Who can participate
Age range
12 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* A histologic confirmation of recurrent/refractory and/or metastatic malignant peripheral nerve sheath tumor with Response Evaluation Criteria in Solid Tumors (RECIST) measurable disease
* Patients ≥ 12 years of age at the time of enrollment
* Performance status: 12-15 years old: Lansky \> 50; 16-17 years old: Karnofsky \> 50; ≥ 18 years old: Eastern Cooperative Group (ECOG) score 0-2
* Subjects must have adequately recovered from the acute toxic effects of all prior anti-cancer therapy per enrolling physician and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment.
* Anti-cancer agents known to be Myelosuppressive: ≥ 28 days after the last dose of agent.
* Anti-cancer agents not known to be myelosuppressive: \> 7 days after the last dose of agent.
* Antibodies: \> 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to Grade \< 1.
* Systemic Corticosteroids: if related to prior therapy \> 14 days must have elapsed, or on stable dose for treatment of CNS disease.
* Hematopoietic growth factors: \> 14 days after the last dose of a long-acting growth factor.
* Interleukins, Interferons, and Cytokines (other than hematopoietic growth factors): \> 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors).
* Radiation therapy (XRT)/External Beam Irradiation including…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.