SL-11047 in Treating Patients With Relapsed or Refractory Lymphoma

Lymphoma Clinical Trial

Official title: An Open Label Phase I Study Evaluating Safety, Tolerability and Pharmacokinetics of SL-11047 in Patients With Refractory Lymphoma

Status Completed

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as SL-11047, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase I trial is studying the side effects and best dose of SL-11047 in treating patients with relapsed or refractory lymphoma.

Clinical Trial Description

OBJECTIVES:

Primary

• Determine the maximum tolerated dose (MTD) of SL-11047 in patients with relapsed or refractory lymphoma.

• Describe and quantify the toxicity of SL-11047 administered to patients with relapsed or refractory lymphoma.

Secondary

• Describe the pharmacokinetics of SL-11047 administered as a 30-minute IV infusion.

• Assess the response rate and duration of response in patients treated with SL-11047.

• Assess the level of SL-11047 within tumor tissues following intravenous administration of the drug.

• Determine the sensitivity of abnormal circulating macrophages to SL-11047.

OUTLINE: This is an open-label, nonrandomized, dose-escalation study.

Patients receive SL-11047 IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of SL-11047 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study. ;

Study Design

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma

• NCT number: NCT00293488
• Study type: Interventional
• Source: Progen Pharmaceuticals
• Status: Completed
• Phase: Phase 1
• Start date: January 2006