Spots Global Cancer Trial Database for Thalidomide and Cyclophosphamide in Treating Children With Recurrent or Refractory Childhood Cancers

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Trial Identification

Brief Title: Thalidomide and Cyclophosphamide in Treating Children With Recurrent or Refractory Childhood Cancers

Official Title: A Phase II Study of Thalidomide and Cyclophosphamide in Patients With Recurrent or Refractory Malignancies

Study ID: NCT00003754

Conditions

Unspecified Childhood Solid Tumor, Protocol Specific

Interventions

cyclophosphamide

thalidomide

Study Description

Brief Summary: RATIONALE: Thalidomide may kill tumor cells by stopping the growth of new blood vessels to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and cyclophosphamide in treating children who have recurrent or refractory childhood cancers.

Detailed Description: OBJECTIVES: I. Determine the efficacy and toxic effects of thalidomide and cyclophosphamide in patients with recurrent or refractory pediatric malignancies. OUTLINE: Patients receive oral thalidomide 4 times daily. Cyclophosphamide is administered IV over 1 hour once every 4 weeks, beginning on the same day as thalidomide. Treatment continues in the absence of unacceptable toxicity or disease progression. Tumor response is assessed every 3 months. PROJECTED ACCRUAL: A total of 45-80 patients will be accrued for this study within 2 years.