Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00470093
Status:
TERMINATED
Last Update Posted:
2018-11-16
First Post:
2007-05-03
Brief Title:
Interferon Alfa and Interleukin-6 in Treating Patients With Recurrent Multiple Myeloma
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A Pilot Study of Differentiation Therapy in Multiple Myeloma Using Interleukin-6 and Interferon-a
Status:
TERMINATED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Interferon alfa may interfere with the growth of cancer cells Interleukin-6 may stimulate the white blood cells to kill cancer cells Giving interferon alfa together with interleukin-6 may kill more cancer cells
PURPOSE This clinical trial is studying the side effects and how well giving interferon alfa together with interleukin-6 works in treating patients with recurrent multiple myeloma
PURPOSE This clinical trial is studying the side effects and how well giving interferon alfa together with interleukin-6 works in treating patients with recurrent multiple myeloma
Detailed Description:
OBJECTIVES
Determine the response rate in patients with recurrent multiple myeloma treated with recombinant interferon alfa and recombinant interleukin-6
Determine the safety and optimal dose of this regimen in these patients
Determine the toxicity of this regimen in these patients
Determine the impact of this regimen on clonogenic growth of myeloma cells in serial in vitro assays
OUTLINE This is a pilot study
Patients receive recombinant interferon alfa subcutaneously SC once daily Beginning 1 month later patients also receive recombinant interleukin-6 SC once daily Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 27 patients will be accrued for this study
Determine the response rate in patients with recurrent multiple myeloma treated with recombinant interferon alfa and recombinant interleukin-6
Determine the safety and optimal dose of this regimen in these patients
Determine the toxicity of this regimen in these patients
Determine the impact of this regimen on clonogenic growth of myeloma cells in serial in vitro assays
OUTLINE This is a pilot study
Patients receive recombinant interferon alfa subcutaneously SC once daily Beginning 1 month later patients also receive recombinant interleukin-6 SC once daily Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 27 patients will be accrued for this study
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 |
|---|---|---|---|
| NA_00002178 | OTHER | JHMIRB | httpsreporternihgovquickSearchP01CA015396 |
| P30CA006973 | NIH | None | None |
| P01CA015396 | NIH | None | None |