Tazemetostat in Malignant Peripheral Nerve Sheath Tumors

  • STATUS
    Recruiting
  • End date
    Sep 15, 2024
  • participants needed
    24
  • sponsor
    University of Florida
Updated on 15 March 2022

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.

Details
Condition Peripheral Nerve Sheath Tumor
Treatment Tazemetostat
Clinical Study IdentifierNCT04917042
SponsorUniversity of Florida
Last Modified on15 March 2022

Eligibility

Yes No Not Sure

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 Protons: > 14 days after local XRT; > 150 days after traumatic brain injury, craniospinal XRT or if radiation to > 50% of the pelvis; > 42 days if other substantial bone marow radiation
Radiopharmaceutical therapy: > 42 days after systemically administered radiopharmaceutical therapy
Major surgery > 14 days prior, with evidence of wound healing and no active surgical complications
Adequate laboratory values of organ function, defined as
Subjects must not have had prior exposure to Tazemetostat or other inhibitor(s) of
Peripheral absolute neutrophil count (ANC) > 1000/mm3
EZH2
Platelet count > 100,000/mm2 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Hemoglobin > 8.0 g/dL at baseline (may receive RBC transfusions)
Creatinine clearance or radioisotope GFR > 70 ml/min/1.73 m2, or serum creatinine based on age/gender
Total bilirubin < 1.5 ULN or direct bilirubin < 1 x ULN
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN; if liver metastases present, then AST and ALT must be < 5 x ULN
Serum albumin > 2 g/dL
Coagulation INR < 1.5, while on anti-coagulation INR < 2.5
Subjects must not have more than one active malignancy at the time of enrollment
Nervous system disorders (CTCAE v5.0) resulting from prior therapy must be < Grade 2
Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures. All subjects and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional standard practice
with the exception of decreased tendon reflex (DTR). Any grade of DTR is
Use of contraception
eligible
Women of childbearing potential (WOCBP) who are heterosexually active must be using two highly effective methods of contraception to avoid pregnancy throughout the study and for at least 6 months after the last dose of study drug to minimize the risk of pregnancy as Tazemetostat might counteract the effects of hormonal contraceptives. Birth control methods that can be used while in this study include: established use of oral, injected or implanted hormonal birth control or placement of an intrauterine device [IUD] or intrauterine system [IUS]. They or their partner must also use a second method, (e.g., condom with spermicidal foam/gel/film/cream/suppository or occlusive cap [diaphragm or cervical/vault caps] with spermicidal foam/gel/film/cream/suppository. If their male partner is vasectomized, they do not need to use any of the birth control methods listed above. The type of birth control they use must be discussed with the study doctor before beginning the study. The study doctor must approve the method you use before they can enter the study. Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy
Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms,vasectomy) throughout the study and should avoid donating sperm, for 90 days following the last dose of study drug

Exclusion Criteria

Subjects who are currently taking the following concomitant medications
Anti-cancer Agents: Subjects who are currently receiving other anti-cancer agents are not eligible
CYP3A4 Agents: Subjects who are currently receiving drugs that are strong inducers or strong inhibitors of CYP3A4 are not eligible. Strong inducers or inhibitors of CYP3A4 are prohibited from 14 days prior to the first dose of Tazemetostat to the end of the study. Note: Dexamethasone for CNS tumors or metastases, on a stable dose, is allowed
Subjects with a prior history of T-cell lymphoblastic lymphoma/T-cell acute lymphoblastic leukemia or myelodysplastic syndrome (MDS)
Subjects who have any of the following underlying major cardiac issues or conditions
Subjects who are acutely ill with an uncontrolled active infection on systemic
Documented New York Heart Association (NYHA) Class III or IV congestive heart failure
anti-infective agents are not eligible
Myocardial infarction within 6 months prior to registration
Unstable angina within 6 months prior to registration
Symptomatic arrhythmia
Known QTc prolongation or documentation
Heterosexually active males or females of reproductive potential may not participate unless they have agreed to use two highly effective contraceptive methods for the duration of study treatment as Tazemetostat might counteract the effects of hormonal contraceptives. Female subjects of childbearing potential should agree to remain abstinent or use adequate contraceptive methods for 6 months after the last dose of Tazemetostat. Male subjects should agree to remain abstinent or use adequate contraceptive methods, and agree to refrain from donating sperm, and for 90 days after the last dose of Tazemetostat
Females who are pregnant or breastfeeding will not be entered on this study because there is currently no available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal
Administration of a vaccine containing live virus within 30 days prior to the first dose of trial treatment. Note: Most flu vaccines are killed viruses, with the exception of the intra-nasal vainer (Flu-Mist) which is an attenuated live virus and therefore prohibited for 30 days prior to first dose. Non-live versions of the COVID-19 vaccine are allowed
Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness
Subjects who in the opinion of the investigator may be high risk for treatment
complications or unable to comply with the safety monitoring requirements of
the study
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