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 range12 Years – 99 Years
SexALL
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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…