NCT00005579

Dolastatin 10 in Treating Patients With Indolent Lymphoma, Waldenstrom's Macroglobulinemia, or Chronic Lymphocytic Leukemia

Phase II Trial of Dolastin 10 in Indolent Lymphoma and Chronic Lymphocytic Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: University of Vermont · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of dolastatin 10 in treating patients with indolent lymphoma, Waldenstrom's macroglobulinemia, or chronic lymphocytic leukemia.

Detailed description

OBJECTIVES: * Estimate the efficacy of dolastatin 10 in patients with indolent lymphoma, Waldenstrom's macroglobulinemia, or chronic lymphocytic leukemia. * Evaluate the qualitative and quantitative toxicities of dolastatin 10 in this patient population. * Investigate the mechanism of action of dolastatin 10 in regards to apoptosis and effects of microtubules. OUTLINE: This is an open-label, multicenter study. Patients are stratified by disease (chronic lymphocytic leukemia vs indolent lymphoma vs Waldenstrom's macroglobulinemia). All patients receive dolastatin 10 IV bolus every 3 weeks. Patients continue treatment until disease progression, unacceptable toxicity, or patient's withdrawal from the study. PROJECTED ACCRUAL: A maximum of 74 patients will be accrued for this study over 15 months.

Conditions

• Leukemia
• Lymphoma

Interventions

Type	Name	Description
DRUG	dolastatin 10

Timeline

• Start date: 1998-06-01
• Completion: 2003-02-01
• First posted: 2003-01-27
• Last updated: 2013-06-26

Locations

4 sites across 1 country: United States