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Clinical Trials in Canada / NCT03213652
Active, not recruiting Phase 2

Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)

NCT03213652 · tracked via the Priya Life Science Canada tracker
Phase
Phase 2
Started
2018-04-17
Last updated
2026-07-10

Condition(s) studied

Advanced Malignant Solid NeoplasmMalignant Solid NeoplasmRecurrent EpendymomaRecurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal TumorRecurrent HepatoblastomaRecurrent Langerhans Cell HistiocytosisRecurrent Malignant Germ Cell TumorRecurrent Malignant GliomaRecurrent Malignant Solid NeoplasmRecurrent MedulloblastomaRecurrent NeuroblastomaRecurrent Non-Hodgkin LymphomaRecurrent OsteosarcomaRecurrent Primary Central Nervous System NeoplasmRecurrent Rhabdoid TumorRecurrent RhabdomyosarcomaRecurrent Soft Tissue SarcomaRefractory EpendymomaRefractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal TumorRefractory HepatoblastomaRefractory Langerhans Cell HistiocytosisRefractory Malignant Germ Cell TumorRefractory Malignant GliomaRefractory Malignant Solid NeoplasmRefractory MedulloblastomaRefractory NeuroblastomaRefractory Non-Hodgkin LymphomaRefractory OsteosarcomaRefractory Primary Central Nervous System NeoplasmRefractory Rhabdoid TumorRefractory RhabdomyosarcomaRefractory Soft Tissue SarcomaWilms Tumor

Investigational drug(s) / intervention(s)

Biospecimen CollectionBone Marrow Aspiration and BiopsyBone ScanComputed TomographyEnsartinib →Laboratory Biomarker AnalysisMagnetic Resonance ImagingPharmacological StudyPositron Emission TomographyRadionuclide ImagingX-Ray Imaging

Biospecimen Collection: Undergo blood sample collection

Bone Marrow Aspiration and Biopsy: Undergo a bone marrow aspiration and/or biopsy

Bone Scan: Undergo a bone scan

Computed Tomography: Undergo a CT scan

Ensartinib: Given PO

Laboratory Biomarker Analysis: Correlative studies

Magnetic Resonance Imaging: Undergo MRI

Pharmacological Study: Correlative studies

Positron Emission Tomography: Undergo a PET scan

Radionuclide Imaging: Undergo radionuclide imaging

X-Ray Imaging: Undergo an x-ray

Study summary

This phase II Pediatric MATCH treatment trial studies how well ensartinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic alterations that have come back (recurrent) or does not respond to treatment (refractory) and may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Ensartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Eligibility

Sex
ALL
Min age
12 Months
Max age
21 Years
Healthy volunteers
No
Inclusion Criteria: * Patient must have enrolled onto APEC1621SC//NCI-2017-01251 and must have been given a treatment assignment to Molecular Analysis for Therapy Choice (MATCH) to APEC1621F/NCI-2017-01243 based on the presence of an actionable mutation as defined in APEC1621SC/ NCI-2017-01251 * Patients must be \>= than 12 months and =\< 21 years of age at the time of study enrollment. * Patients must have a body surface area \>= 0.5 m\^2 at enrollment * Patients must have radiographically measurable disease at the time of study enrollment. Patients with neuroblastoma who do not have measurable disease but have iobenguane (MIBG) positive (+) evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as any lesion that is at minimum 10 mm in one dimension on a standard MRI or CT * Note: The following do not qualify as measurable disease: * Malignant fluid collections (e.g., ascites, pleural effusions) * Bone marrow infiltration except that detected by MIBG scan for neuroblastoma * Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography \[PET\] scans) except as noted for neuroblastoma * Elevated tumor markers in plasma or cerebrospinal fluid (CSF) * Previously radiated lesions that have not demonstrated clear progression post radiation * Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * Karnofsky \>= 50% for patients \> 16 years of age and Lansky \>= 50 for patients =\< 16 years of age * Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score * Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately * Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive: \>= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea) * Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil counts \[ANC\] counts): \>= 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 * Corticosteroids: if used to modify immune adverse events related to prior therapy, \>= 14 days must have elapsed since last dose of corticosteroid * Hematopoietic growth factors: \>= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator * Interleukins, interferons and cytokines (other than hematopoietic growth factors): \>= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors) * Stem cell Infusions (with or without total body irradiation \[TBI\]): * Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: \>= 84 days after infusion and no evidence of graft versus host disease (GVHD) * Autologous stem cell infusion including boost infusion: \>= 42 days * Cellular therapy: \>= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer \[NK\] cells, dendritic cells, etc.) * Radiation therapy (XRT)/external beam irradiation including protons: \>= 14 days after local XRT; \>= 150 days after TBI, craniospinal XRT or if radiation to \>= 50% of the pelvis; \>= 42 days if other substantial none marrow (BM) radiation * Note: Radiation may not be delivered to "measurable disease" tumor site(s) being used to follow response to subprotocol treatment * Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): \>= 42 days after systemically administered radiopharmaceutical therapy * Patients must not have received prior exposure to ensartinib; prior treatment with other ALK inhibitors is permitted given that at least 5 half-lives or 21 days have elapsed since therapy discontinuation, whichever is greater * For patients with solid tumors without known bone marrow involvement: * Peripheral absolute neutrophil count (ANC) \>= 1000/mm\^3 (within 7 days prior to enrollment) * Platelet count \>= 100,000/mm\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) (within 7 days prior to enrollment) * Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity * Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 ml/min/1.73 m\^2 (within 7 days prior to enrollment) or a serum creatinine based on age/gender as follows (within 7 days prior to enrollment): * Age 1 to \< 2 years: maximum serum creatinine 0.6 mg/dL for male and 0.6 mg/dL for female * Age 2 to \< 6 years: maximum serum creatinine 0.8 mg/dL for male and 0.8 mg/dL for female * Age 6 to \< 10 years: maximum serum creatinine 1 mg/dL for male and 1 mg/dL for female * Age 10 to \< 13 years: maximum serum creatinine 1.2 mg/dL for male and 1.2 mg/dL for female * Age 13 to \< 16 years: maximum serum creatinine 1.5 mg/dL for male and 1.4 mg/dL for female * Age \>= 16 years: maximum serum creatinine 1.7 mg/dL for male and 1.4 mg/dL for female * Bilirubin (sum of conjugated + unconjugated) =\< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment) * Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 135 U/L (within 7 days prior to enrollment) (for the purpose of this study, the ULN for SGPT is 45 U/L) * Serum albumin \>= 2 g/dL (within 7 days prior to enrollment) * Patients must be able to swallow intact capsules * All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines Exclusion Criteria: * Pregnant or breast-feeding women 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; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of study treatment and for one week after the last dose of ensartinib * Concomitant medications * Corticosteroids: patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, \>= 14 days must have elapsed since last dose of corticosteroid * Investigational drugs: patients who are currently receiving another investigational drug are not eligible * Anti-cancer agents: patients who are currently receiving other anti-cancer agents are not eligible * Anti-GVHD agents post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial * CYP3A4 agents: patients who are currently receiving drugs that are strong inducers or strong inhibitors of CYP3A4 are not eligible; strong inducers or inhibitors of CYP3A4 should be avoided from 14 days prior to enrollment to the end of the study * Note: CYP3A4 inducing anti-epileptic drugs and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed * Patients who have an uncontrolled infection are not eligible * Patients who have received a prior solid organ transplantation are not eligible * Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible

Primary outcome measure(s)

Trial sites (126)

FacilityCityRegionStatus
Children's Hospital of Alabama Birmingham Alabama
Providence Alaska Medical Center Anchorage Alaska
Banner Children's at Desert Mesa Arizona
Banner University Medical Center - Tucson Tucson Arizona
Arkansas Children's Hospital Little Rock Arkansas
Kaiser Permanente Downey Medical Center Downey California
Loma Linda University Medical Center Loma Linda California
Miller Children's and Women's Hospital Long Beach Long Beach California
Children's Hospital Los Angeles Los Angeles California
Valley Children's Hospital Madera California
UCSF Benioff Children's Hospital Oakland Oakland California
Kaiser Permanente-Oakland Oakland California
Children's Hospital of Orange County Orange California
University of California Davis Comprehensive Cancer Center Sacramento California
UCSF Medical Center-Mission Bay San Francisco California
Children's Hospital Colorado Aurora Colorado
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver Colorado
Yale University New Haven Connecticut
Alfred I duPont Hospital for Children Wilmington Delaware
Children's National Medical Center Washington D.C. District of Columbia
UF Health Cancer Institute - Gainesville Gainesville Florida
Nemours Children's Clinic-Jacksonville Jacksonville Florida
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
Nicklaus Children's Hospital Miami Florida
AdventHealth Orlando Orlando Florida
Arnold Palmer Hospital for Children Orlando Florida
Nemours Children's Hospital Orlando Florida
Nemours Children's Clinic - Pensacola Pensacola Florida
Johns Hopkins All Children's Hospital St. Petersburg Florida
Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta Georgia
Saint Luke's Cancer Institute - Boise Boise Idaho
Lurie Children's Hospital-Chicago Chicago Illinois
University of Chicago Comprehensive Cancer Center Chicago Illinois
OSF Children's Hospital of Illinois Peoria Illinois
Southern Illinois University School of Medicine Springfield Illinois
Riley Hospital for Children Indianapolis Indiana
Blank Children's Hospital Des Moines Iowa
University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
Norton Children's Hospital Louisville Kentucky

+ 86 more sites — see the full list on the official registry below.

More National Cancer Institute (NCI) trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03213652 on ClinicalTrials.gov ↗ ← All trials in Canada