NCT00003754

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Unspecified Childhood Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	cyclophosphamide
DRUG	thalidomide

Timeline

• Start date: 1998-09-01
• Primary completion: 2001-07-01
• Completion: 2001-07-01
• First posted: 2004-04-09
• Last updated: 2013-06-26

Locations

1 site across 1 country: United States