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| ID | Type | Description | Link |
|---|---|---|---|
| MK-9999-01A | Other Identifier | MSD | |
| LIGHTBEAM-U01 | Other Identifier | MSD | |
| 2023-507178-41-00 | Registry Identifier | EU CT | |
| U1111-1295-3459 | Registry Identifier | UTN | |
| jRCT2031250824 | Registry Identifier | Japan Registry of Clinical Trial (jRCT) |
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Substudy 01A is part of a platform study. The purpose of this study is to assess the efficacy and safety of zilovertamab vedotin in pediatric participants with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), diffuse large B-cell lymphoma (DLBCL)/Burkitt lymphoma, or neuroblastoma and in pediatric and young adult participants with Ewing sarcoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zilovertamab vedotin | Experimental | Participants receive escalating doses of zilovertamab vedotin via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zilovertamab vedotin | Biological | Administered via IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants from 1 to <18 years of Age Who Experience a Dose-Limiting Toxicity (DLT) | Number of participants experiencing toxicities that are possibly, probably, or definitely related to study therapy; that meet pre-defined severity criteria; and result in a change in the given dose. | Up to 42 days |
| Part 1: Number of Participants from 1 to <18 years of Age Who Experience One or More Adverse Events (AEs) | An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality. The number of participants in Part 1 who experience at least 1 AE will be presented. | Up to approximately 54 months |
| Part 1: Number of Participants from 1 to <18 years of Age Who Discontinue Study Treatment Due to AEs | An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality. The number of participants in Part 1 who discontinue study treatment due to an AE will be presented. | Up to approximately 54 months |
| Part 1: Number of Participants from 1 to <18 years of Age Who Receive Dose Modification Due to AEs | An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality. The number of participants in Part 1 who receive a dose modification due to an AE will be presented. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 and Part 2: Area Under the Curve (AUC) of Total Antibody | Blood samples collected at designated time points will be used to determine the AUC of total antibody. | Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months) |
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The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles ( Site 1006) | Recruiting | Los Angeles | California | 90027 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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| Up to approximately 54 months |
| Part 1 and Part 2: Objective Response (OR) for Participants with B-Cell Acute Lymphoblastic Leukemia (B-ALL) | OR for participants with B-ALL is defined as complete response (CR) or complete response with incomplete hematologic recovery (CRi) based on investigator's assessment per Ponte-di-Legno Consortium criteria. For Part 1 and Part 2, the OR for participants with B-ALL as assessed by investigator will be presented. | Up to approximately 54 months |
| Part 1 and Part 2: OR for Participants with Diffuse Large B-Cell Lymphoma (DLBCL)/Burkitt Lymphoma, Neuroblastoma, and Ewing Sarcoma | OR for participants with DLBCL/Burkitt lymphoma, neuroblastoma, and Ewing sarcoma is defined as complete response (CR) or partial response (PR) based on investigator's assessment per International Pediatric Non-Hodgkin Lymphoma (IPNHL) Response Criteria for participants with DLBCL/Burkitt lymphoma, per International Neuroblastoma Response Criteria (INRC) for neuroblastoma, and per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for Ewing sarcoma. For Part 1 and Part 2, the OR for participants with DLBCL/Burkitt lymphoma, neuroblastoma, and Ewing sarcoma as assessed by investigator will be presented. | Up to approximately 54 months |
| Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of Total Antibody | Blood samples collected at designated time points will be used to determine the Cmax of total antibody. | Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months) |
| Part 1 and Part 2: Plasma Trough Concentration (Ctrough) of Total Antibody | Blood samples collected at designated time points will be used to determine the Ctrough of total antibody. | Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months) |
| Part 1 and Part 2: Apparent Terminal Half-life (t1/2) of Total Antibody | Blood samples collected at designated time points will be used to determine the t1/2 of total antibody. | Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months) |
| Part 1 and Part 2: AUC of Antibody-Drug Conjugate (ADC) | Blood samples collected at designated time points will be used to determine the AUC of ADC. | Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months) |
| Part 1 and Part 2: Cmax of ADC | Blood samples collected at designated time points will be used to determine the Cmax of ADC. | Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months) |
| Part 1 and Part 2: Ctrough of ADC | Blood samples collected at designated time points will be used to determine the Ctrough of ADC. | Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months) |
| Part 1 and Part 2: t1/2 of ADC | Blood samples collected at designated time points will be used to determine the t1/2 of ADC. | Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months) |
| Part 1 and Part 2: AUC of Monomethyl Auristatin E (MMAE) | Blood samples collected at designated time points will be used to determine the AUC of MMAE. | Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months) |
| Part 1 and Part 2: Cmax of MMAE | Blood samples collected at designated time points will be used to determine the Cmax of MMAE. | Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months) |
| Part 1 and Part 2: Ctrough of MMAE | Blood samples collected at designated time points will be used to determine the Ctrough of MMAE. | Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months) |
| Part 1 and Part 2: t1/2 of MMAE | Blood samples collected at designated time points will be used to determine the t1/2 of MMAE. | Predose on Day 1 of Cycles 1 through 6 and every 4 cycles thereafter, at end of infusion on Day 1 of Cycles 1 and 3, and on Days 3, 8, and 15 of Cycles 1 and 3. Each cycle is 21 days. (Up to approximately 54 months) |
| Part 2: Number of Participants Who Experience One or More AEs | An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality. The number of participants in Part 2 who experience at least 1 AE will be presented. | Up to approximately 54 months |
| Part 2: Number of Participants Who Discontinue Study Treatment Due to AEs | An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality. The number of participants in Part 2 who discontinue study treatment due to an AE will be presented. | Up to approximately 54 months |
| Part 2: Number of Participants Who Receive Dose Modification Due to AEs | An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality. The number of participants in Part 2 who receive a dose modification due to an AE will be presented. | Up to approximately 54 months |
| Part 1 and Part 2: Incidence of Antidrug Antibodies (ADAs) to Zilovertamab Vedotin | Blood samples collected at designated timepoints will be used to determine the ADA response to zilovertamab vedotin. The incidence of ADAs over time will be presented. | Predose on Day 1 of Cycles 1, 2, 3, 4, 5, 6 and every 4 cycles thereafter. Each cycle is 21 days. (Up to approximately 54 months) |
| Part 1 and Part 2: Duration of Response (DOR) | DOR is defined as the time from the first documented evidence of CR/CRi for B-ALL or CR/PR for DLBCL/Burkitt lymphoma, Ewing sarcoma, and neuroblastoma until disease progression or death due to any cause, whichever occurs first. For participants under 1-year of age, the time from the first dose will start from the first dose a participant receives during Part 2. | Up to approximately 54 months |
| Part 1 and Part 2: Percentage of Participants with DLBCL/Burkitt Lymphoma Who Receive Stem Cell Transplant (SCT) | The percentage of participants with DLBCL/Burkitt Lymphoma who go on to receive SCT will be presented. | Up to approximately 54 months |
| Part 1 and Part 2: Percentage of Participants with B-ALL Who Receive SCT | The percentage of participants with B-ALL who go on to receive SCT will be presented. | Up to approximately 54 months |
| Part 1 and Part 2: Percentage of Participants with B-ALL Who Receive Chimeric Antigen Receptor T (CAR-T) | The percentage of participants with B-ALL who go on to receive CAR-T will be presented. | Up to approximately 54 months |
| Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 1016) | Recruiting | Aurora | Colorado | 80045 | United States |
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| Yale New Haven Hospital ( Site 1012) | Recruiting | New Haven | Connecticut | 06510 | United States |
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| Johns Hopkins All Children's Hospital ( Site 1025) | Recruiting | St. Petersburg | Florida | 33701 | United States |
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| University of Iowa-Holden Comprehensive Cancer Center ( Site 1017) | Recruiting | Iowa City | Iowa | 52242 | United States |
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| Dana-Farber Cancer Institute ( Site 1013) | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Corewell Health ( Site 1001) | Recruiting | Grand Rapids | Michigan | 49503 | United States |
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| Children's Mercy Hospital ( Site 1024) | Recruiting | Kansas City | Missouri | 64108 | United States |
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| Rutgers Cancer Institute of New Jersey ( Site 1008) | Recruiting | New Brunswick | New Jersey | 08903 | United States |
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| Memorial Sloan Kettering Cancer Center ( Site 1010) | Recruiting | New York | New York | 10065 | United States |
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| New York Medical College ( Site 1023) | Recruiting | Valhalla | New York | 10595 | United States |
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| Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 1003) | Recruiting | Fargo | North Dakota | 58102 | United States |
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| Oregon Health and Science University ( Site 1004) | Recruiting | Portland | Oregon | 97239 | United States |
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| Children's Hospital of Philadelphia (CHOP) ( Site 1021) | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Sanford Children's Hospital-Sanford Children's Specialty Clinic ( Site 1015) | Recruiting | Sioux Falls | South Dakota | 57105 | United States |
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| University of Texas MD Anderson Cancer Center ( Site 1007) | Recruiting | Houston | Texas | 77030 | United States |
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| Intermountain - Primary Children's Hospital ( Site 1014) | Recruiting | Salt Lake City | Utah | 84113 | United States |
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| Sydney Children's Hospital ( Site 1997) | Recruiting | Randwick | New South Wales | 2031 | Australia |
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| Queensland Children's Hospital-Oncology & Haematology ( Site 1996) | Recruiting | Brisbane | Queensland | 4101 | Australia |
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| Royal Children's Hospital-Children's Cancer Centre ( Site 1994) | Recruiting | Melbourne | Victoria | 3052 | Australia |
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| UZ Gent ( Site 1428) | Recruiting | Ghent | Oost-Vlaanderen | 9000 | Belgium |
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| Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1268) | Completed | Curitiba | Paraná | 81520-060 | Brazil |
| Hospital de Clinicas de Porto Alegre ( Site 1265) | Recruiting | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
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| Fundação Pio XII - Hospital de Câncer de Barretos ( Site 1264) | Recruiting | Barretos | São Paulo | 14784400 | Brazil |
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| Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site 1267) | Recruiting | São José do Rio Preto | São Paulo | 15090000 | Brazil |
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| The Hospital for Sick Children ( Site 1225) | Recruiting | Toronto | Ontario | M5G 1X8 | Canada |
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| McGill University Health Centre-Pediatric HematologyOncology ( Site 1223) | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
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| Hospital Clínico Regional Dr. Guillermo Grant Benavente ( Site 1881) | Recruiting | Concepción | Biobio | 4070038 | Chile |
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| Hospital Luis Calvo Mackenna ( Site 1879) | Recruiting | Santiago | Region M. de Santiago | 7500539 | Chile |
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| Hospital Carlos Van Buren ( Site 1880) | Recruiting | Valparaíso | Valparaiso | 2341131 | Chile |
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| Hospital Pablo Tobon Uribe ( Site 1923) | Recruiting | Medellín | Antioquia | 050034 | Colombia |
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| Clinica de la Costa S.A.S.-Clinical Research Oncology & Hematology -Pediatric ( Site 1924) | Recruiting | Barranquilla | Atlántico | 080020 | Colombia |
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| IMAT S.A.S ( Site 1921) | Recruiting | Montería | Departamento de Córdoba | 230002 | Colombia |
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| Detska nemocnice FN Brno ( Site 1388) | Recruiting | Brno | Brno-mesto | 613 00 | Czechia |
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| Fakultni nemocnice v Motole-Klinika detske hematologie a onkologie ( Site 1387) | Recruiting | Prague | Praha 5 | 150 00 | Czechia |
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| Rigshospitalet-Department of paediatrics and adolescent medicine, Section of Paed haem-onc ( Site 1467) | Recruiting | Copenhagen | Capital Region | DK-2100 | Denmark |
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| CHU de Bordeaux. Hopital Pellegrin ( Site 1105) | Recruiting | Bordeaux | Aquitaine | 33076 | France |
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| CENTRE LEON BERARD-IHOPE (pediatrric oncology) ( Site 1100) | Recruiting | Lyon | Auvergne-Rhône-Alpes | 69373 | France |
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| Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 1104) | Recruiting | Nantes | Loire-Atlantique | 44093 | France |
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| Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1102) | Recruiting | Marseille | Provence-Alpes-Côte d'Azur Region | 13005 | France |
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| Gustave Roussy ( Site 1103) | Recruiting | Villejuif | Île-de-France Region | 94805 | France |
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| Universitaetsklinikum Tuebingen ( Site 1142) | Recruiting | Tübingen | Baden-Wurttemberg | 72076 | Germany |
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| Universitaetsklinikum Koeln. Klinik und Poliklinik ( Site 1145) | Recruiting | Cologne | North Rhine-Westphalia | 50937 | Germany |
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| Universitätsklinikum Münster - Albert Schweitzer Campus-Pädiatrische Hämatologie und Onkologie ( Site 1141) | Recruiting | Münster | North Rhine-Westphalia | 48149 | Germany |
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| Charité Campus Virchow-Klinikum-Klinik für Pädiatrie mit Schwerpunkt Hämatologie und Onkologie ( Site 1143) | Recruiting | Berlin | 13353 | Germany |
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| Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi ( Site 1797) | Recruiting | Athens | Attica | 115 27 | Greece |
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| Semmelweis Egyetem ( Site 1838) | Recruiting | Budapest | 1085 | Hungary |
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| Rambam Health Care Campus-Pediatric Hemato-Oncology ( Site 1674) | Recruiting | Haifa | 3109601 | Israel |
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| Sheba Medical Center ( Site 1675) | Recruiting | Ramat Gan | 5265601 | Israel |
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| Fondazione IRCCS Istituto Nazionale dei Tumori-Pediatric Oncology ( Site 1552) | Recruiting | Milan | Lombardy | 20133 | Italy |
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| Ospedale Pediatrico Bambino Gesù IRCCS-Dipartimento di Onco-Ematologia e Terapia Cellulare e Genica ( Site 1553) | Recruiting | Rome | Roma | 00165 | Italy |
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| Ospedale Infantile Regina Margherita-S.C. Oncoematologia Pediatrica ( Site 1551) | Recruiting | Torino | 10126 | Italy |
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| Prinses Maxima Centrum voor Kinderoncologie ( Site 1510) | Recruiting | Utrecht | 3584 CS | Netherlands |
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| Narodny ustav detskych chorob ( Site 1592) | Recruiting | Bratislava | Bratislava Region | 831 01 | Slovakia |
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| Seoul National University Hospital-Pediatrics ( Site 1972) | Recruiting | Seoul | 03080 | South Korea |
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| Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 1973) | Recruiting | Seoul | 05505 | South Korea |
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| Hospital Sant Joan de Déu-Pediatric Oncology Department ( Site 1717) | Recruiting | Esplugas de Llobregat | Barcelona | 08950 | Spain |
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| Hospital Infantil Universitario Niño Jesús-Servicio de Onco-Hematología Pediátrica ( Site 1715) | Recruiting | Madrid | Madrid, Comunidad de | 28009 | Spain |
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| Hospital Universitario y Politecnico La Fe de Valencia ( Site 1718) | Recruiting | Valencia | Valenciana, Comunitat | 46026 | Spain |
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| Hospital Universitari Vall d'Hebron-Servei de Hematologia i Oncologia Pediatrica ( Site 1716) | Recruiting | Barcelona | 08035 | Spain |
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| Sahlgrenska Universitetssjukhuset ( Site 1634) | Recruiting | Gothenburg | Västra Götaland County | 416 85 | Sweden |
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| National Taiwan University Hospital ( Site 1983) | Recruiting | Taipei | 10002 | Taiwan |
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| Ege Universitesi Hastanesi ( Site 1963) | Recruiting | Bornova | İzmir | 35100 | Turkey (Türkiye) |
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| Hacettepe Universite Hastaneleri ( Site 1961) | Recruiting | Ankara | 06230 | Turkey (Türkiye) |
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| Ankara Bilkent Şehir Hastanesi ( Site 1962) | Recruiting | Ankara | 06800 | Turkey (Türkiye) |
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| Birmingham Children's Hospital-Oncology/Haematology ( Site 1349) | Recruiting | Birmingham | England | B4 6NH | United Kingdom |
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| Royal Victoria Infirmary-Great North Children's Hospital ( Site 1348) | Recruiting | Newcastle upon Tyne | England | NE1 4PL | United Kingdom |
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| University College London Hospital ( Site 1350) | Recruiting | London | London, City of | NW1 2PG | United Kingdom |
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| Royal Marsden Hospital (Sutton)-Drug Development Unit ( Site 1347) | Recruiting | Sutton | Surrey | SM2 5PT | United Kingdom |
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| University Hospital of Wales ( Site 1346) | Recruiting | Cardiff | CF14 4XW | United Kingdom |
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| ID | Term |
|---|---|
| D002051 | Burkitt Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D009447 | Neuroblastoma |
| D012512 | Sarcoma, Ewing |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D012516 | Osteosarcoma |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D012509 | Sarcoma |
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