Thalidomide and Cyclophosphamide in Treating Children With Recurrent or Refractory Childhood Cancers
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.
|Unspecified Childhood Solid Tumor, Protocol Specific||Drug: cyclophosphamide Drug: thalidomide||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study of Thalidomide and Cyclophosphamide in Patients With Recurrent or Refractory Malignancies|
|Study Start Date:||September 1998|
|Study Completion Date:||July 2001|
|Primary Completion Date:||July 2001 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003754
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Ira Dunkel, MD||Memorial Sloan Kettering Cancer Center|