NCT00005982

506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma

Phase II Study of 506U78 (NSC #686673) in Patients With Previously Treated Cutaneous T-Cell Lymphoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase II trial to study the effectiveness of 506U78 in treating patients who have recurrent or refractory cutaneous T-cell lymphoma

Detailed description

PRIMARY OBJECTIVES: I. Determine the response rate, failure-free survival, and progression-free survival of patients with recurrent or refractory cutaneous T-cell lymphoma treated with 506U78. II. Determine the toxicity of this drug in these patients. III. Study the pharmacokinetics of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months. PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 3 years.

Conditions

• Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
• Recurrent Mycosis Fungoides/Sezary Syndrome

Interventions

Type	Name	Description
DRUG	nelarabine	Given IV
OTHER	pharmacological study	Correlative studies

Timeline

• Start date: 2000-04-01
• Primary completion: 2004-07-01
• First posted: 2003-01-27
• Last updated: 2013-01-23

Locations

1 site across 1 country: United States