Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002849
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
1999-11-01
Brief Title:
S9628 Dexamethasone Plus Interferon Alfa in Treating Patients With Primary Systemic Amyloidosis
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase II Study of DexamethasoneAlpha-Interferon in AL Amyloidosis
Status:
COMPLETED
Status Verified Date:
2015-03
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 Chemotherapy plus interferon alfa may be effective for primary systemic amyloidosis
PURPOSE Phase II trial to study the effectiveness of dexamethasone plus interferon alfa in treating patients who have primary systemic amyloidosis
PURPOSE Phase II trial to study the effectiveness of dexamethasone plus interferon alfa in treating patients who have primary systemic amyloidosis
Detailed Description:
OBJECTIVES
Evaluate M protein and organ dysfunction responses and overall and progression-free survival in patients with primary systemic amyloidosis treated with dexamethasoneinterferon alfa
Identify prognostic factors that may relate to response and overall survival in these patients
Evaluate the qualitative and quantitative toxic effects of this regimen
OUTLINE Patients are stratified by prior amyloidosis treatment yes vs no
All patients receive induction therapy with oral dexamethasone on days 1-4 9-12 and 17-20 every 35 days for a total of 3 courses
Maintenance therapy begins within 5-8 weeks within 10 weeks if patients undergo stem cell harvest of initiation of the third course of induction as follows oral dexamethasone for 4 days every 4 weeks and subcutaneous interferon alfa 3 times per week Patients who achieved less than a 50 reduction in serum M protein or urinary Bence-Jones protein and who experienced less than grade 3 toxicity during induction receive 3 additional courses of pulse dexamethasone concurrently with entry to maintenance therapy and the initiation of interferon alfa
Combination therapy is continued until 2 years from entry thereafter interferon is administered alone for at least 3 years toxicity permitting Patients with stable disease after 5 years of therapy may discontinue interferon alfa at the discretion of the treating physician
Patients are followed every 6 months for 2 years and yearly thereafter
PROJECTED ACCRUAL A total of 100 patients 50 with prior melphalanprednisone or iododoxorubicin treatment and 50 without will be entered over 3 years
Evaluate M protein and organ dysfunction responses and overall and progression-free survival in patients with primary systemic amyloidosis treated with dexamethasoneinterferon alfa
Identify prognostic factors that may relate to response and overall survival in these patients
Evaluate the qualitative and quantitative toxic effects of this regimen
OUTLINE Patients are stratified by prior amyloidosis treatment yes vs no
All patients receive induction therapy with oral dexamethasone on days 1-4 9-12 and 17-20 every 35 days for a total of 3 courses
Maintenance therapy begins within 5-8 weeks within 10 weeks if patients undergo stem cell harvest of initiation of the third course of induction as follows oral dexamethasone for 4 days every 4 weeks and subcutaneous interferon alfa 3 times per week Patients who achieved less than a 50 reduction in serum M protein or urinary Bence-Jones protein and who experienced less than grade 3 toxicity during induction receive 3 additional courses of pulse dexamethasone concurrently with entry to maintenance therapy and the initiation of interferon alfa
Combination therapy is continued until 2 years from entry thereafter interferon is administered alone for at least 3 years toxicity permitting Patients with stable disease after 5 years of therapy may discontinue interferon alfa at the discretion of the treating physician
Patients are followed every 6 months for 2 years and yearly thereafter
PROJECTED ACCRUAL A total of 100 patients 50 with prior melphalanprednisone or iododoxorubicin treatment and 50 without will be entered over 3 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 |
|---|---|---|---|
| S9628 | OTHER | None | None |
| CLB-9790 | OTHER | None | None |
| CLB-S9628 | OTHER | None | None |
| U10CA032102 | NIH | CALGB | httpsreporternihgovquickSearchU10CA032102 |