Dolastatin 10 in Treating Patients With Indolent Lymphoma, Waldenstrom's Macroglobulinemia, or Chronic Lymphocytic Leukemia
|ClinicalTrials.gov Identifier: NCT00005579|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma||Drug: dolastatin 10||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Dolastin 10 in Indolent Lymphoma and Chronic Lymphocytic Leukemia|
|Study Start Date :||June 1998|
|Study Completion Date :||February 2003|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005579
|United States, Maryland|
|Marlene and Stewart Greenebaum Cancer Center, University of Maryland|
|Baltimore, Maryland, United States, 21201|
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|United States, Ohio|
|Arthur G. James Cancer Hospital - Ohio State University|
|Columbus, Ohio, United States, 43210-1240|
|United States, Vermont|
|Vermont Cancer Center|
|Burlington, Vermont, United States, 05401-3498|
|Study Chair:||Steven M. Grunberg, MD||University of Vermont|