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A PHASE II PILOT STUDY OF SURAMIN IN PREVIOUSLY TREATED PATIENTS WITH MULTIPLE MYELOMA AND PATIENTS WITH CASTLEMAN'S DISEASE


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

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.

Inclusion Criteria


DISEASE CHARACTERISTICS: Confirmed diagnosis of active multiple myeloma Refractory (less
than a partial response) to or relapsed after standard chemotherapy Myeloma protein
present for response evaluation Nonsecretory myeloma eligible if plasmacytosis greater
than 30% OR Pathologic diagnosis of Castleman's disease Multicentric or symptomatic
disease requiring therapy Measurable or evaluable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy:
At least 1 year Hematopoietic: Absolute granulocyte count greater than 1,500/mm3 Platelet
count greater than 100,000/mm3 Hepatic: Bilirubin normal SGOT no greater than 2 times
upper limit of normal PT and PTT normal No coagulopathy Renal: Creatinine less than 1.5
mg/dL OR Creatinine clearance greater than 70 mL/min Calcium no greater than 12 mg/dL
Other: No severe psychiatric disorder that would preclude informed consent No known
seizure disorder No peripheral neuropathy or POEMS (polyneuropathy, organomegaly,
endocrinopathy, monoclonal gammopathy, and skin changes) syndrome No uncontrolled or
brittle diabetes mellitus HIV negative No other active medical illness that would preclude
study No other malignancy within the past 5 years except nonmelanomatous skin cancer or
stage IA cervical carcinoma Not pregnant or nursing Negative pregnancy test Fertile
patients must use effective contraception during and for 6 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy
Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6
weeks since prior mitomycin or nitrosoureas) Endocrine therapy: At least 4 weeks since
prior glucocorticoids (e.g., prednisone, dexamethasone) Radiotherapy: At least 4 weeks
since prior radiotherapy No prior radiotherapy to more than 20% of bone marrow Surgery: At
least 4 weeks since prior surgery Other: Recovered from the toxic effects of prior therapy
No other concurrent therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Nikhil C. Munshi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arkansas

Authority:

United States: Federal Government

Study ID:

CDR0000064185

NCT ID:

NCT00002652

Start Date:

May 1995

Completion Date:

February 2004

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • refractory multiple myeloma
  • Neoplasms
  • Giant Lymph Node Hyperplasia
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205