Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002652
Status:
COMPLETED
Last Update Posted:
2013-02-04
First Post:
1999-11-01
Brief Title:
Suramin in Treating Patients With Refractory or Relapsed Multiple Myeloma or Castlemans Disease
Sponsor:
University of Arkansas
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A PHASE II PILOT STUDY OF SURAMIN IN PREVIOUSLY TREATED PATIENTS WITH MULTIPLE MYELOMA AND PATIENTS WITH CASTLEMANS DISEASE
Status:
COMPLETED
Status Verified Date:
2002-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Castlemans disease
PURPOSE Phase II trial to study the effectiveness of suramin in treating patients who have refractory or relapsed multiple myeloma or Castlemans disease
Detailed Description:
OBJECTIVES I Determine the tumor response of patients with refractory or relapsed multiple myeloma or Castlemans disease treated with suramin II Determine the effects of this regimen on cytokine-mediated symptoms in patients with Castlemans disease III Determine the overall and progression-free survival in patients with multiple myeloma or Castelmans 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 Castlemans disease will be accrued for this study within 29-8 years
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 Castlemans disease will be accrued for this study within 29-8 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-T94-0176O | None | None | None |
| UARK-94016 | None | None | None |