Recurrent Malignancies (recurrent solid tumors): Target tumor types were osteosarcoma, Ewing sarcoma/peripheral PNET, rhabdomyosarcoma, neuroblastoma (measurable disease), neuroblastoma (metaiodobenzylguanidine [MIBG]+ evaluable disease), ependymoma, medulloblastoma/supratentorial PNET, and non-brainstem high-grade glioma.
Conditions
Interventions
Trade Name: ALIMTA
Product Name: ALIMTA
Pharmaceutical Form: Powder for concentrate for solution for injection/infusion
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must have osteosarcoma, Ewing's sarcoma, medulloblastoma, neuroblastoma, rhabdomyosarcoma, ependymoma or high-grade non-brainstem glioma •Measurable disease •Eastern Cooperative Oncology Group (ECOG) performance 0,1,2 •Adequate renal, liver and bone marrow function •Patient's current disease state must be one with no known curative therapy or therapy proven to prolong survival with an acceptable quality of life Are the trial subjects under 18? yes Number of subjects for this age range: 57 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Growth factors that support platelet or white cell number or function must not have been administered within the last 7 days prior to enrollment (14 days if Neulasta) •Patients with central nervous system (CNS) tumors who have not been on a stable or decreasing dose of dexamethasone or other corticosteroid for 7 days prior to enrollment •Patients with uncontrolled infection •Patients who have received pemetrexed previously •Patients with pleural effusions or ascites
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of Study H3E-MC-JMHW (JMHW) was to estimate the response rates to pemetrexed administered intravenously every 21 days in children with relapsed or refractory osteosarcoma, Ewing sarcoma/peripheral PNET, rhabdomyosarcoma, neuroblastoma, ependymoma, medulloblastoma/supratentorial PNET, or non-brainstem high-grade glioma and to further define and describe the toxicities of pemetrexed.;Secondary Objective: The secondary objectives of this study were: • to examine the relationship between the presence of the C677T polymorphism of the methylene tetrahydrofolate reductase gene and toxicity of patients being treated with pemetrexed • to examine the relationship between the presence of a polymorphism in the TS gene and/or gene promoter and toxicity of patients being treated with pemetrexed • to examine the relationship between response and tumor expression of the enzymes TS, DHFR, GARFT, reduced folate carrier, folylpolyglutamate synthase, and gamma-glutamyl hydrolase. Also, the relationship between response and methylthioadenosine phosphorylase deletion status will be examined. The pharmacogenetic and correlative studies were optional and required a separate consent.;Primary end point(s): Percentage of Participants With Overall Tumor Response (Response Rate) ;Timepoint(s) of evaluation of this end point: Time Frame: baseline to measured progressive disease (up to 1 year) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug [ Time Frame: every cycle (up to 2 years and 7 months) ] Pharmacogenomics - Measure the Response of Genes Related to Toxicity [ Time Frame: baseline ] ;Timepoint(s) of evaluation of this end point: Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug [ Time Frame: every cycle (up to 2 years and 7 months) ] Pharmacogenomics - Measure the Response of Genes Related to Toxicity [ Time Frame: baseline ] | — |
Countries
United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed