Suramin in Treating Patients With Refractory or Relapsed Multiple Myeloma or Castleman's Disease
|ClinicalTrials.gov Identifier: NCT00002652|
Recruitment Status : Completed
First Posted : March 1, 2004
Last Update Posted : February 4, 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 suramin in treating patients who have refractory or relapsed multiple myeloma or Castleman's disease.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm||Drug: suramin||Phase 2|
OBJECTIVES: I. Determine the tumor response of patients with refractory or relapsed multiple myeloma or Castleman's disease treated with suramin. II. Determine the effects of this regimen on cytokine-mediated symptoms in patients with Castleman's disease. III. Determine the overall and progression-free survival in patients with multiple myeloma or Castelman's disease treated with this regimen. IV. Determine the qualitative, quantitative, and cumulative toxic effects of this regimen in these patients. V. Determine the effect of this regimen on the levels of serum interleukin-6 (IL-6), soluble IL-6 receptor, and soluble gp130 in these patients.
OUTLINE: Patients receive suramin on days 1-5, 8, 11, 15, 19, 22, and 29. During course 1, patients also receive suramin on days 36, 43, 50, 57, 64, 71, and 78. Suramin is administered IV over 2 hours on day 1 of course 1 and over 1 hour on all subsequent infusion days. Patients undergo rest for at least 12 weeks between each course. Patients with responding disease after completion of course 2 may receive additional courses in the absence of unacceptable toxicity. Patients are followed weekly for 1 month, every 2 weeks for 1 month, at 3 months, and then monthly thereafter if indicated.
PROJECTED ACCRUAL: A total of 20-40 patients with multiple myeloma will be accrued for this study within 10-20 months. A total of 20-40 patients with Castleman's disease will be accrued for this study within 2.9-8 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A PHASE II PILOT STUDY OF SURAMIN IN PREVIOUSLY TREATED PATIENTS WITH MULTIPLE MYELOMA AND PATIENTS WITH CASTLEMAN'S DISEASE|
|Study Start Date :||May 1995|
|Actual Study Completion Date :||February 2004|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002652
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|Study Chair:||Nikhil C. Munshi, MD||University of Arkansas|