A Study of Pemetrexed in Children With Recurrent Cancer

Lilly

Status and phase

Completed

Phase 2

Conditions

Osteosarcoma

Neuroblastoma (Measurable Disease)

Rhabdomyosarcoma

Sarcoma, Ewing's

Neuroblastoma (Metaiodobenzylguanidine

Positive Evaluable)

Medulloblastoma

Ependymoma

Non-brainstem High-grade Glioma

Treatments

Drug: pemetrexed

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT00520936

ADVL0525 (Other Identifier)

10294

H3E-MC-JMHW (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

Under 22 years old

Volunteers

No Healthy Volunteers

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