Phase II Study of 506U78 (NSC #686673) in Patients With Previously Treated Cutaneous T-Cell Lymphoma
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (RR) defined as CR + PR rates
Up to 4 years
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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