Dolastatin 10 in Treating Patients With Indolent Lymphoma, Waldenstrom's Macroglobulinemia, or Chronic Lymphocytic Leukemia
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|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|
|Actual Study Completion Date :||February 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|