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A Phase II Study of Pemetrexed in Children with Recurrent Malignancies

[Protocol 07-179]

Full Title :

A PHASE II STUDY OF PEMETREXED IN CHILDREN WITH RECURRENT MALIGNANCIES (COG ADVL 0525)

Purpose :

Pemetrexed (Alimta^®) is a drug approved for treating lung cancer. It is also being evaluated for the treatment of other types of cancer. Pemetrexed works by preventing cancer cells from using folate, a naturally occurring vitamin which the body uses to help normal cells keep growing. Pemetrexed interferes with several places where folate works in the cell.

Since cancer cells usually grow faster than normal cells, cancer cells should be affected by pemetrexed more than normal cells. If pemetrexed can prevent cancer cells from using folate, this may help inhibit a cancer from growing.

In this Children's Oncology Group study, researchers are assessing the effectiveness of pemetrexed in children with cancers that have continued to grow or have returned despite standard therapies. The study will focus on the effects of pemetrexed in children and adolescents with specific tumors that have been shown to respond to antifolate drugs, including osteosarcoma, Ewing sarcoma/peripheral PNET, rhabdomyosarcoma, neuroblastoma, ependymoma, medulloblastoma/supratentorial PNET, and non-brainstem high-grade glioma.

Researchers are also seeking to learn if the genetic makeup of a person affects the side effects and effectiveness of pemetrexed treatment.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

• Patients must have a confirmed diagnosis of osteosarcoma, Ewing sarcoma/peripheral PNET, rhabdomyosarcoma, neuroblastoma, ependymoma, medulloblastoma/supratentorial PNET, or non-brainstem high-grade glioma which continues to grow or has returned despite prior therapy.
• Patients must be under age 22.
• Patients must not be confined to a bed or chair for more than half of their normal waking hours.
• Patients must have recovered from the major side effects of any prior therapies.

For more information and to inquire about eligibility for this study, please contact Dr. Tanya Trippett at 212-639-8267 or Dr. Ira Dunkel at 212-639-2153.