506U78 in Treating Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

Lymphoma Clinical Trial

Official title: Compound 506U78 (NSC 686673) in Patients With Relapsed or Refractory T-Cell ALL or T-Cell Lymphoblastic Lymphoma

Status Completed

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Clinical trial to study the effectiveness of 506U78 in treating patients who have relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.

Clinical Trial Description

OBJECTIVES:

• Provide an investigational agent, 506U78, to physicians for the management of individual patients with relapsed or refractory T-cell acute lymphoblastic (lymphocytic) leukemia or T-cell lymphoblastic lymphoma who are not candidates for entry onto ongoing research clinical trials of higher priority.

• Evaluate the toxic effects of 506U78 when administered as a 2 hour IV infusion 3 days a week every 21 days in these patients.

• Evaluate the antitumor efficacy of this regimen in terms of rate of complete responses in these patients.

OUTLINE: Patients receive 506U78 over 2 hours on days 1, 3, and 5. Treatment repeats every 21 days for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for one year and then every 6 months until death.

PROJECTED ACCRUAL: A minimum of 25 patients will be accrued for this study. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, Non-Hodgkin
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

• NCT number: NCT00003837
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: N/A
• Start date: September 1999
• Completion date: November 2007