| ID | Type | Description | Link |
|---|---|---|---|
| H3E-MC-JMHW | Other Identifier | Eli Lilly and Company | |
| ADVL0525 | Other Identifier | Children's Oncology Group |
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| Name | Class |
|---|---|
| Children's Oncology Group | NETWORK |
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To determine the response rate of pemetrexed given every 21 days for the treatment of children with relapsed or refractory osteosarcoma, Ewing's sarcoma/peripheral primitive neuroectodermal tumors (PNET), rhabdomyosarcoma, neuroblastoma, ependymoma, medulloblastoma/supratentorial PNET or non-brain stem high-grade glioma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pemetrexed | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pemetrexed | Drug | 1910 milligrams per meter squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old), intravenous (IV), for 21 days x 17 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Overall Tumor Response (Response Rate) | Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response = disappearance of all target lesions. Partial Response = 30% decrease in sum of longest diameter of target lesions. Response rate (percent [%])= (number of participants with complete response (CR) or partial response (PR) in stratum/number of participants in stratum)*100. | baseline to measured progressive disease (up to 1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug | AdEERS= Adverse Event Expedited Reporting System; AE = adverse event. Patients may be counted in more than 1 category. Includes events that were considered possibly related to study drug (PRSD) as judged by the investigator. | every cycle (up to 2 years and 7 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Arcadia | California | 91066 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Osteosarcoma | Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old) |
| FG001 | Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors | Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old) |
| FG002 | Rhabdomyosarcoma | Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old) |
| FG003 | Neuroblastoma (Measureable Disease) | Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old) |
| FG004 | Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable) | Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old) |
| FG005 | Ependymoma | Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old) |
| FG006 | Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor | Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old) |
| FG007 | Non-Brainstem High-Grade Glioma | Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Osteosarcoma | Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old) |
| BG001 | Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Overall Tumor Response (Response Rate) | Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response = disappearance of all target lesions. Partial Response = 30% decrease in sum of longest diameter of target lesions. Response rate (percent [%])= (number of participants with complete response (CR) or partial response (PR) in stratum/number of participants in stratum)*100. | All treated participants. | Posted | Number | Percentage of Participants | baseline to measured progressive disease (up to 1 year) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pemetrexed | Pemetrexed 1910 mg/m2 (or 60 mg/kg if patient <12 months old) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection with normal ANC or Grade 1 | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| D008527 | Medulloblastoma |
| D012512 | Sarcoma, Ewing |
| D009447 | Neuroblastoma |
| D012208 | Rhabdomyosarcoma |
| D004806 | Ependymoma |
| ID | Term |
|---|---|
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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|
| Pharmacogenomics - Measure the Response of Genes Related to Toxicity | The pharmacogenomics outcomes examining the correlation between the presence of the methylene tetrahydrofolate reductase gene and the presence of a polymorphism in the thymidylate synthase (TS) gene and/or gene promoter and toxicity were optional and will not be reported here. Results of this optional research may be reported in the future by the Children's Oncology Group in the peer-reviewed literature. | baseline |
| United States |
| Withdrawal by Subject |
|
| Toxicity Requiring Removal from Study |
|
| Death |
|
| Protocol Violation |
|
Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
| BG002 | Rhabdomyosarcoma | Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old) |
| BG003 | Neuroblastoma (Measureable Disease) | Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old) |
| BG004 | Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable) | Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old) |
| BG005 | Ependymoma | Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old) |
| BG006 | Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor | Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old) |
| BG007 | Non-Brainstem High-Grade Glioma | Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old) |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Number | participants |
|
| Karnofsky Performance Score | Classifies patients according to their functional impairment. Scores range from 0-100, the lower the score, the worse the survival for most serious illnesses. 100 - Normal no complaints; no evidence of disease 90 - Normal activity; minor signs of disease 80 - Activity with effort; some signs of disease 70 - Unable to carry on normal activity <=60 Needs increasing assistance up to Death (0) | Number | Participants |
|
| Lansky Play Score | 100=fully active, normal. 90=minor restrictions in physically strenuous activity. 80=active, but tires more quickly. 70=both greater restriction of and less time spent in play activity. 60=up and around, but minimal active play; keeps busy with quieter activities. 50=gets dressed, but lies around much of the day; no active play, able to participate in all quiet play activities. 40=mostly in bed; participates in quiet activities. 30=in bed; needs assistance even for quiet play. 20=often sleeping; play entirely limited to very passive activities. 10=No play; does not get out of bed. | Number | Participants |
|
Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old) |
| OG002 | Rhabdomyosarcoma | Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old) |
| OG003 | Neuroblastoma (Measureable Disease) | Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old) |
| OG004 | Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable) | Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old) |
| OG005 | Ependymoma | Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old) |
| OG006 | Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor | Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old) |
| OG007 | Non-Brainstem High-Grade Glioma | Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old) |
|
|
| Secondary | Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug | AdEERS= Adverse Event Expedited Reporting System; AE = adverse event. Patients may be counted in more than 1 category. Includes events that were considered possibly related to study drug (PRSD) as judged by the investigator. | All treated participants. | Posted | Number | Participants | every cycle (up to 2 years and 7 months) |
|
|
|
| Secondary | Pharmacogenomics - Measure the Response of Genes Related to Toxicity | The pharmacogenomics outcomes examining the correlation between the presence of the methylene tetrahydrofolate reductase gene and the presence of a polymorphism in the thymidylate synthase (TS) gene and/or gene promoter and toxicity were optional and will not be reported here. Results of this optional research may be reported in the future by the Children's Oncology Group in the peer-reviewed literature. | The pharmacogenomics outcomes examining the correlation between the presence of the methylene tetrahydrofolate reductase gene and the presence of a polymorphism in the thymidylate synthase (TS) gene and/or gene promoter and toxicity were optional and will not be reported here. | Posted | Number | Correlation coefficient | baseline |
|
|
| 21 |
| 72 |
| 10 |
| 72 |
| Hemoglobin | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Infection | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Infection with normal ANC or Grade 1 | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Leukocytes | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Neutrophils/granulocytes | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pain: Tumor pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ulceration | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Fever | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Flushing | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pain: Extremity-limb | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dyspnea | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Rash/desquamation | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| GGT | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Albumin, serum-low | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Calcium, serum-low | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Phosphate, serum-low | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Potassium, serum-low | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hemorrhage, CNS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypotension | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Mood alteration: Depression | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Death not associated with CTCAE term | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Rash: erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dermatology/Skin - Other | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pulmonary/Upper Respiratory - Other | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Thrombosis/thrombus/embolism | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Sodium, serum-low | Congenital, familial and genetic disorders | MedDRA 11.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hemorrhage, GI: Rectum | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pain: Tumor pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Fever | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Seizure | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Hemorrhage, GU: Urinary NOS | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
Not provided
| D009369 | Neoplasms |
| D012509 | Sarcoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D018242 | Neuroectodermal Tumors, Primitive |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D009217 | Myosarcoma |
| D009379 | Neoplasms, Muscle Tissue |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| Discontinued due to AE possibly related to drug |
|
| Died on therapy possibly related to study drug |
|
| Died within 31 days of last dose of drug PRSD |
|