A Study of Pemetrexed in Children With Recurrent Cancer

A Phase II Study of Pemetrexed in Children With Recurrent Malignancies

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.

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