NCT00062244

Oblimersen in Treating Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia

Phase I/II Study of G3139 (Genasense) in Patients With Waldenstrom's Macroglobulinemia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial is studying the side effects and best dose of oblimersen and to see how well it works in treating patients with relapsed or refractory Waldenstrom's macroglobulinemia. Biological therapies such as oblimersen may interfere with the growth of the cancer cells and slow or stop the growth of Waldenstrom's macroglobulinemia.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose (MTD) and recommended dosing for Genasense in patients with relapsed or refractory WM following prior chemotherapy. (Phase I) II. To determine the response rate to Genasense in patients with relapsed or refractory WM following prior chemotherapy. III. To determine the safety of Genasense in patients with relapsed or refractory WM following prior chemotherapy. IV. To describe possible clinical benefit from Genasense treatment of relapsed or refractory WM including duration of response, survival, erythropoietin use, improvement in hemoglobin \> 11 g/dl, and Improvement in platelet count \> 100,000/mm\^3. OUTLINE: This is a multicenter, dose-escalation study. Phase I: Patients receive oblimersen IV continuously on days 1-7. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 1-6 patients receive escalating doses of oblimersen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Phase II: Patients receive treatment as in phase I at the MTD of oblimersen. Patients are followed every 3 months for 2 years.

Conditions

• Waldenström Macroglobulinemia

Interventions

Type	Name	Description
BIOLOGICAL	oblimersen sodium	Given IV

Timeline

• Start date: 2003-05-01
• Primary completion: 2007-06-01
• First posted: 2003-06-06
• Last updated: 2013-06-04

Locations

8 sites across 1 country: United States