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Suramin in Treating Patients With Refractory or Relapsed Multiple Myeloma or Castleman's Disease Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Suramin in Treating Patients With Refractory or Relapsed Multiple Myeloma or Castleman's Disease conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Suramin in Treating Patients With Refractory or Relapsed Multiple Myeloma or Castleman's Disease Clinical research trials and Suramin in Treating Patients With Refractory or Relapsed Multiple Myeloma or Castleman's Disease medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Suramin in Treating Patients With Refractory or Relapsed Multiple Myeloma or Castleman's Disease. Suramin in Treating Patients With Refractory or Relapsed Multiple Myeloma or Castleman's Disease Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Suramin in Treating Patients With Refractory or Relapsed Multiple Myeloma or Castleman's Disease clinical trial. Subjects often receive the most expert healthcare possible for their Suramin in Treating Patients With Refractory or Relapsed Multiple Myeloma or Castleman's Disease condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Suramin in Treating Patients With Refractory or Relapsed Multiple Myeloma or Castleman's Disease  Suramin in Treating Patients With Refractory or Relapsed Multiple Myeloma or Castleman's Disease
Suramin in Treating Patients With Refractory or Relapsed Multiple Myeloma or Castleman's Disease
For Condition: refractory plasma cell neoplasm
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , University of Arkansas
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NikhilMunshi, Study Chair, University of Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Additional Information:
Study ID Numbers: CDR0000064185; UARK-94016,NCI-T94-0176O
Study Start Date: May 1995
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002652
Other Refractory Plasma Cell Neoplasm Studies:
1. Brostallicin in Treating Patients With Recurrent or Refractory Multiple Myeloma
2. Beta Alethine in Treating Patients With Myeloma
3. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
4. Bevacizumab With or Without Thalidomide in Treating Patients With Relapsed or Refractory Multiple Myeloma
5. Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Related Studies:
Other refractory plasma cell neoplasm Clinical Trials
Other Arkansas Clinical Trials
Other Little Rock Clinical Trials
Suramin in Treating Patients With Refractory or Relapsed Multiple Myeloma or Castleman's Disease
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