Solid Neoplasm Clinical Trial
Official title:
Larotrectinib (LOXO-101, NSC# 788607) for Previously Untreated TRK Fusion Pediatric Solid Tumors and TRK Fusion Relapsed Pediatric Acute Leukemias
Verified date | March 2024 |
Source | Children's Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase II trial studies the side effects and how well larotrectinib works in treating patients with previously untreated TRK fusion solid tumors and TRK fusion acute leukemia that has come back. Larotrectinib may stop the growth of cancer cells with TRK fusions by blocking the TRK enzymes needed for cell growth.
Status | Active, not recruiting |
Enrollment | 70 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 30 Years |
Eligibility | Inclusion Criteria: - Patients must be =< 30 years of age at the time of study entry - COHORT A: Patients must have a histologic diagnosis of infantile fibrosarcoma with an NTRK1, NTRK2, or NTRK3 fusion identified in a Clinical Laboratory Improvement Act/College of American Pathologists (CLIA/CAP) certified laboratory. Fusions may be identified by fluorescence in situ hybridization (FISH) or molecular techniques (reverse transcriptase-polymerase chain reaction [RT-PCR] using primers flanking the fusion junction or next generation sequencing). For fusions identified by FISH, an ETV6 rearrangement is sufficient for eligibility in Cohort A. Identification of the upstream TRK fusion partner is not required. - COHORT B: Patients must have a histologic diagnosis of any solid tumor other than infantile fibrosarcoma, including central nervous system (CNS) tumors but excluding high grade gliomas. An NTRK1, NTRK2, or NTRK3 fusion must be identified in a CLIA/CAP certified laboratory. Fusions may be identified by FISH or molecular techniques (RT-PCR using primers flanking the fusion junction or next generation sequencing). For fusions identified by FISH, there must be an identified rearrangement in NTRK1, NTRK2, or NTRK3 (e.g., an ETV6 rearrangement is not sufficient for eligibility) unless the patient has a diagnosis of congenital mesoblastic nephroma in which case an ETV6 rearrangement is sufficient for eligibility. Identification of the upstream TRK fusion partner is not required. - COHORT C: Patients must have a histologic diagnosis of relapsed or refractory acute leukemia with an NTRK1, NTRK2, or NTRK3 fusion identified in a CLIA/CAP certified laboratory. Fusions may be identified by FISH or molecular techniques (RT-PCR using primers flanking the fusion junction or next generation sequencing). For fusions identified by FISH, there must be an identified rearrangement in NTRK1, NTRK2, or NTRK3 (e.g., an ETV6 rearrangement is not sufficient for eligibility). Identification of the upstream TRK fusion partner is not required. - SOLID TUMORS (COHORTS A AND B): Patients must have measurable disease. Patients must have disease that cannot be completely resected without a predicted functional, neurologic, or significant cosmetic deficit in the opinion of the investigator. - LEUKEMIA (COHORT C): Patients must have >= 5% blasts in the bone marrow. Extramedullary disease is permitted. - Patients must have a Lansky or Karnofsky performance status score of >= 50, corresponding to Eastern Cooperative Oncology Group (ECOG) categories 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age. NOTE: Neurologic deficits in patients with CNS tumors must have been 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. - COHORTS A AND B: No prior anti-cancer therapy, including radiotherapy, other than surgical resection is permitted. - Patients who experience recurrence after surgery alone and no other anti-cancer therapy will be eligible. - If not eligible due to prior anticancer therapy, patients may be eligible for the larotrectinib arm of Pediatric MATCH (APEC1621A) or treatment with commercial larotrectinib off study. - COHORT C: Patients with relapsed leukemia (Cohort C) 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. The duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment. - A waiting period prior to enrollment is not required for patients receiving standard cytotoxic maintenance chemotherapy (i.e., corticosteroid, vincristine, thioguanine [6MP], and/or methotrexate). - A waiting period is not required for patients receiving a single dose of intrathecal methotrexate, hydrocortisone, and/or cytarabine within 7 days prior to enrollment. - >= 14 days must have elapsed after the completion of other cytotoxic therapy, with the exception of hydroxyurea, for patients not receiving standard maintenance therapy. Additionally, patients must have fully recovered from all acute toxic effects of prior therapy. - Note: Cytoreduction with hydroxyurea must be discontinued >= 24 hours prior to the start of protocol therapy. - Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or absolute neutrophil [ANC] counts): >= 7 days after the last dose of agent. The duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment. - Anti-cancer agents that are 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. There is an exception for blinatumomab infusions, for which patients must have been off for at least 3 days and all drug related toxicity must have resolved to grade 2 or lower as outlined in the inclusion/exclusion criteria. - Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid. A waiting period prior to enrollment is not required for patients receiving corticosteroid for leukemia therapy/cytoreduction. - 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 agents 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 BM radiation. - Radiopharmaceutical therapy (e.g., radiolabeled antibody): >= 42 days after systemically administered radiopharmaceutical therapy. - Patients must not have received prior exposure to TRK inhibitors (including larotrectinib, LOXO-195, entrectinib, lorlatinib, crizotinib, or lestaurtinib). - For patients with solid tumors without known bone marrow involvement: Peripheral absolute neutrophil count (ANC) >= 1000/mm^3 (within 7 days prior to enrollment). - For patients with solid tumors without known bone marrow involvement: Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment). - For patients with solid tumors without known bone marrow involvement: Hemoglobin >= 8.0 g/dL at baseline (within 7 days prior to enrollment) (may receive red blood cell [RBC] transfusions). - Patients with solid tumors with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts above (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. - For patients with leukemia: Platelet count >= 20,000/mm^3 (within 7 days prior to enrollment) (may receive platelet transfusions; must not be known to be refractory to red cell or platelet transfusion). - For patients with leukemia: Hemoglobin >= 8.0 g/dL at baseline (within 7 days prior to enrollment) (may receive RBC transfusions; must not be known to be refractory to red cell or platelet transfusion). - Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows (within 7 days prior to enrollment): - 1 month to < 6 months (male 0.4 mg/dL, female 0.4 mg/dL) - 6 months to < 1 year (male 0.5 mg/dL, female 0.5 mg/dL) - 1 to < 2 years (male 0.6 mg/dL, female 0.6 mg/dL) - 2 to < 6 years (male 0.8 mg/dL, female 0.8 mg/dL) - 6 to < 10 years (male 1 mg/dL, female 1 mg/dL) - 10 to < 13 years (male 1.2 mg/dL, female 1.2 mg/dL) - 13 to < 16 years (male 1.5 mg/dL, female 1.4 mg/dL) - >= 16 years (male 1.7 mg/dL, female 1.4 mg/dL) - For patients < 1 month of age, serum creatinine levels must be < 1.5 x the treating institution's creatinine upper limit of normal (ULN) for patients < 1 month of age or the creatinine clearance or radioisotope GFR must be >= 70 mL/min/1.73 m^2. - Patients with solid tumors: Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment). After approval of the study chair or designee, infants with a higher total bilirubin due to physiologic or breast milk jaundice are eligible if the conjugated (direct) bilirubin is =< 2 mg/dL. - Patients with solid tumors: Serum glutamate pyruvate 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. - Patients with solid tumors: Serum albumin >= 2 g/dL (within 7 days prior to enrollment). - Patients with leukemias: Conjugated (direct) bilirubin =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment). - Patients with leukemias: SGPT (ALT) =< 225 U/L (within 7 days prior to enrollment). For the purpose of this study, the ULN for SGPT is 45 U/L. - Patients with leukemias: Serum albumin >= 2 g/dL (within 7 days prior to enrollment). - Patients with seizure disorder may be enrolled if on a stable antiepileptic regimen for >= 14 days and well controlled. - Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5) except tendon reflex decreased resulting from prior therapy must be =< grade 2. - All patients and/or their parents or legal guardians must sign a written informed consent. - All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met. Exclusion Criteria: - Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies, OR because there is yet no available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Female patients of reproductive potential may not participate unless they have agreed to use a highly effective contraceptive method for the duration of study therapy and for at least one month after the final dose of larotrectinib. Males of reproductive potential with a non-pregnant female partner of child-bearing potential must use a highly effective contraception for the duration of the study and for at least one month after the final dose of larotrectinib. Because of the unknown risk of larotrectinib in nursing infants, nursing women should discontinue breastfeeding during treatment with larotrectinib and for 3 days following the final dose. - Patients with solid tumors, including CNS tumors, requiring corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. Patients with leukemia may receive systemic corticosteroids for cytoreduction up to 24 hours prior to the start of protocol therapy. If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid. - Patients who are currently receiving another investigational drug are not eligible. - Patients who are currently receiving other anti-cancer agents are not eligible [except leukemia patients receiving corticosteroids or hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy]. Patients with leukemia should receive a single dose of intrathecal cytarabine, hydrocortisone, and/or methotrexate within 7 days prior to Day 1 of Cycle 1 at the time of the baseline lumbar puncture. - 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. - Patients currently receiving a strong CYP3A4 inducer or inhibitor 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 with malabsorption syndrome or other conditions that significantly limit enteral absorption are not eligible. - Patients who are unable to swallow capsules or liquid and do not have gastric access via a nasogastric or gastrostomy tube are not eligible. - Patients who have an uncontrolled infection are not eligible. - Patients who have received 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. - Patients with high grade gliomas (HGG) are not eligible. |
Country | Name | City | State |
---|---|---|---|
Canada | IWK Health Centre | Halifax | Nova Scotia |
Canada | Centre Hospitalier Universitaire Sainte-Justine | Montreal | Quebec |
United States | Children's Hospital Medical Center of Akron | Akron | Ohio |
United States | Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania |
United States | C S Mott Children's Hospital | Ann Arbor | Michigan |
United States | Mission Hospital | Asheville | North Carolina |
United States | Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia |
United States | Children's Hospital Colorado | Aurora | Colorado |
United States | Dell Children's Medical Center of Central Texas | Austin | Texas |
United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
United States | Children's Hospital of Alabama | Birmingham | Alabama |
United States | Saint Luke's Cancer Institute - Boise | Boise | Idaho |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Montefiore Medical Center - Moses Campus | Bronx | New York |
United States | Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina |
United States | Novant Health Presbyterian Medical Center | Charlotte | North Carolina |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Nationwide Children's Hospital | Columbus | Ohio |
United States | Medical City Dallas Hospital | Dallas | Texas |
United States | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas |
United States | Dayton Children's Hospital | Dayton | Ohio |
United States | Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver | Colorado |
United States | Kaiser Permanente Downey Medical Center | Downey | California |
United States | Broward Health Medical Center | Fort Lauderdale | Florida |
United States | Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida |
United States | University of Florida Health Science Center - Gainesville | Gainesville | Florida |
United States | Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids | Michigan |
United States | BI-LO Charities Children's Cancer Center | Greenville | South Carolina |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii |
United States | Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas |
United States | Riley Hospital for Children | Indianapolis | Indiana |
United States | University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Nemours Children's Clinic-Jacksonville | Jacksonville | Florida |
United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
United States | Children's Mercy Hospitals and Clinics | Kansas City | Missouri |
United States | Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire |
United States | Arkansas Children's Hospital | Little Rock | Arkansas |
United States | Children's Hospital Los Angeles | Los Angeles | California |
United States | Norton Children's Hospital | Louisville | Kentucky |
United States | University of Wisconsin Carbone Cancer Center | Madison | Wisconsin |
United States | Marshfield Medical Center-Marshfield | Marshfield | Wisconsin |
United States | Saint Jude Children's Research Hospital | Memphis | Tennessee |
United States | Jackson Memorial Hospital-Holtz Children's Hospital | Miami | Florida |
United States | Nicklaus Children's Hospital | Miami | Florida |
United States | University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida |
United States | Children's Hospital of Wisconsin | Milwaukee | Wisconsin |
United States | University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota |
United States | Morristown Medical Center | Morristown | New Jersey |
United States | Yale University | New Haven | Connecticut |
United States | Ochsner Medical Center Jefferson | New Orleans | Louisiana |
United States | NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York |
United States | Children's Hospital of The King's Daughters | Norfolk | Virginia |
United States | Kaiser Permanente-Oakland | Oakland | California |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Children's Hospital and Medical Center of Omaha | Omaha | Nebraska |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Children's Hospital of Orange County | Orange | California |
United States | Nemours Children's Hospital | Orlando | Florida |
United States | Saint Jude Midwest Affiliate | Peoria | Illinois |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Saint Christopher's Hospital for Children | Philadelphia | Pennsylvania |
United States | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania |
United States | Oregon Health and Science University | Portland | Oregon |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
United States | Cardinal Glennon Children's Medical Center | Saint Louis | Missouri |
United States | Mercy Hospital Saint Louis | Saint Louis | Missouri |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Primary Children's Hospital | Salt Lake City | Utah |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | UCSF Medical Center-Mission Bay | San Francisco | California |
United States | Seattle Children's Hospital | Seattle | Washington |
United States | Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington |
United States | Mary Bridge Children's Hospital and Health Center | Tacoma | Washington |
United States | Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida |
United States | Children's National Medical Center | Washington | District of Columbia |
United States | MedStar Georgetown University Hospital | Washington | District of Columbia |
United States | Alfred I duPont Hospital for Children | Wilmington | Delaware |
Lead Sponsor | Collaborator |
---|---|
Children's Oncology Group | National Cancer Institute (NCI) |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response rate (ORR) of children with infantile fibrosarcoma (IFS) treated with neoadjuvant larotrectinib prior to local control | Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed accounting for the two-stage design. | Up to 5 years | |
Secondary | Event-free survival (EFS) of children with IFS treated with neoadjuvant larotrectinib prior to local control | Will be computed one year after the last enrollment in a stratum. | Up to 5 years | |
Secondary | Overall survival (OS) of children with IFS treated with neoadjuvant larotrectinib prior to local control | Will be computed one year after the last enrollment in a stratum. | Up to 5 years | |
Secondary | Duration of response (DoR) of children with IFS treated with neoadjuvant larotrectinib prior to local control | Will be computed one year after the last enrollment in a stratum. Will be defined among patients with a confirmed best response of either PR and CR. | From first observation of either partial response (PR) or complete response (CR) until either the first observation of progressive disease (PD) (event) or last known observation of the patient (censored observation), assessed up to 5 years | |
Secondary | ORR of children with newly diagnosed TRK fusion solid tumors other than IFS treated with neoadjuvant larotrectinib prior to local control | Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed accounting for the two-stage design. | Up to 5 years | |
Secondary | EFS of children with newly diagnosed TRK fusion solid tumors other than IFS treated with neoadjuvant larotrectinib prior to local control | Will be computed one year after the last enrollment in a stratum. | Up to 5 years | |
Secondary | OS of children with newly diagnosed TRK fusion solid tumors other than IFS treated with neoadjuvant larotrectinib prior to local control | Will be computed one year after the last enrollment in a stratum. | Up to 5 years | |
Secondary | DoR of children with newly diagnosed TRK fusion solid tumors other than IFS treated with neoadjuvant larotrectinib prior to local control | Will be computed one year after the last enrollment in a stratum. Will be defined among patients with a confirmed best response of either PR and CR. | From first observation of either partial response (PR) or complete response (CR) until either the first observation of progressive disease (PD) (event) or last known observation of the patient (censored observation), assessed up to 5 years | |
Secondary | Incidence of adverse events | Per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Toxicity tables will be constructed to summarize the observed incidence by type of toxicity and grade. A patient will be counted only once for a given toxicity for the worst grade of that toxicity reported for that patient. Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the attribution(s) to the study regimen. | Up to 5 years | |
Secondary | Percentage of patients with TRK fusion solid tumors with detectable circulating tumor deoxyribonucleic acid (DNA) | The percentage of ctDNA and frequency with which patients have detectable ctDNA prior to the start of therapy and at times during therapy when subsequent serial samples are obtained will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit). In cases of treatment resistance, we will also perform exploratory deep sequencing of ctDNA to determine whether this method can detect the emergence of resistance mutations. | Baseline up to 5 years |
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