A Study of Pemetrexed in Children With Recurrent Cancer

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Children's Oncology Group
• Treatments: Pemetrexed

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

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