A Study of Pemetrexed in Children With Recurrent Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Osteosarcoma Medulloblastoma Sarcoma, Ewing's Neuroblastoma (Measurable Disease) Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable) Rhabdomyosarcoma Ependymoma Non-brainstem High-grade Glioma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pemetrexed

Group Type EXPERIMENTAL

pemetrexed

Intervention Type 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

Interventions

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pemetrexed

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

Intervention Type DRUG

Other Intervention Names

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LY 231514 Alimta

Eligibility Criteria

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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

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

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No