A PHASE II PILOT STUDY OF SURAMIN IN PREVIOUSLY TREATED PATIENTS WITH MULTIPLE MYELOMA AND PATIENTS WITH CASTLEMAN'S DISEASE
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.
Primary Purpose: Treatment
Nikhil C. Munshi, MD
University of Arkansas
United States: Federal Government
|University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|