506U78 in Treating Patients With Lymphoma

Anaplastic Large Cell Lymphoma Clinical Trial

Official title: A Phase II Study of 506U78 in Patients With Previously Systemically Untreated Cutaneous T-cell Lymphoma (CTCL) or With Refractory or Relapsed Non-cutaneous Peripheral T-cell Lymphoma (PTCL)

Status Completed

Clinical Trial Summary

Phase II trial to study the effectiveness of 506U78 in treating patients who have lymphoma that has not been treated previously or that has not responded to previous treatment. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die

Clinical Trial Description

PRIMARY OBJECTIVES:

I. Determine the complete and partial remission rates and remission duration in patients with cutaneous T-cell lymphoma or refractory or relapsed noncutaneous peripheral T-cell lymphoma treated with 506U78.

II. Determine the safety and toxicity of this treatment regimen in this patient population.

OUTLINE:

Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response receive up to 8 courses of therapy.

Patients are followed every 3 months for 1 year and then every 6 months for 1 year or until relapse.

PROJECTED ACCRUAL: A total of 34-74 patients will be accrued for this study within 3 years. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anaplastic Large Cell Lymphoma
• Angioimmunoblastic T-cell Lymphoma
• Leukemia, T-Cell
• Leukemia-Lymphoma, Adult T-Cell
• Lymphoma
• Lymphoma, Large-Cell, Anaplastic
• Lymphoma, Non-Hodgkin
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Mycoses
• Mycosis Fungoides
• Recurrent Adult T-cell Leukemia/Lymphoma
• Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
• Recurrent Mycosis Fungoides/Sezary Syndrome
• Sezary Syndrome
• Small Intestine Lymphoma
• Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
• Stage I Mycosis Fungoides/Sezary Syndrome
• Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
• Stage II Mycosis Fungoides/Sezary Syndrome
• Stage III Cutaneous T-cell Non-Hodgkin Lymphoma
• Stage III Mycosis Fungoides/Sezary Syndrome
• Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
• Stage IV Mycosis Fungoides/Sezary Syndrome
• Syndrome

• NCT number: NCT00005080
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 2
• Start date: May 2000