Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003416
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
1999-11-01
Brief Title:
S9805 High-Dose Melphalan Plus Peripheral Stem Cell Transplantation Followed by Interferon Alfa in Treating Patients With Waldenstroms Macroglobulinemia
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
S9805 Phase II Study of Tandem High Dose Melphalan Supported by Peripheral Blood Stem Cell Support in Waldenstroms Macroglobulinemia WM
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells Interferon alfa may interfere with the growth of the cancer cells
PURPOSE Phase II trial to study the effectiveness of high-dose melphalan plus peripheral stem cell transplantation followed by interferon alfa in treating patients with Waldenstroms macroglobulinemia
PURPOSE Phase II trial to study the effectiveness of high-dose melphalan plus peripheral stem cell transplantation followed by interferon alfa in treating patients with Waldenstroms macroglobulinemia
Detailed Description:
OBJECTIVES I Assess remission rates and overall and progression-free survival in patients with Waldenstroms macroglobulinemia treated with tandem high dose melphalan supported by peripheral blood stem cell support II Assess the associated hematologic and nonhematologic toxicities of this regimen in these patients
OUTLINE Regimen A dexamethasone induction All patients receive high dose dexamethasone orally on days 1-4 9-12 and 17-20 courses repeat every 35 days for a total of 3 courses Regimen B stem cell mobilization and collection Following a 4-6 week break after dexamethasone induction and regardless of response or progression patients have stem cells collected following administration of filgrastim G-CSF by injection G-CSF continues until completion of stem cell collection maximum of 6 aphereses Regimen C first peripheral blood stem cell transplant PBSCT Regardless of disease progression patients recovered from toxicities from dexamethasone induction and stem cell mobilization and collection and who have adequate number of CD34 cells collected for at least 1 transplant receive 1 dose of melphalan daily for 2 days followed by peripheral stem cell reinfusion G-CSF is given by injection beginning on the day after peripheral stem cell reinfusion and continues until the absolute granulocyte count is greater than 1000mm3 on 3 consecutive days Regimen D second PBSCT Patients who had adequate stem cell collection for 2 transplants during regimen B have no evidence of disease progression after the first transplant and have recovered from effects of previous treatment undergo a second treatment with high dose melphalan with PBSCT and G-CSF support given 3-12 months following the first transplant Patients who had enough cells collected for only one transplant go directly to regimen E Regimen E maintenance interferon alfa Beginning 5-12 weeks after transplant and upon hematologic recovery of blood counts and other toxicities patients with at least a partial response after high dose melphalan and PBSCT receive subcutaneous interferon alfa injections 3 times a week for 5 years or until disease progression relapse or toxicity Patients are followed every month for 6 months then every 3 months for 5 years then annually thereafter
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study over 4 years
OUTLINE Regimen A dexamethasone induction All patients receive high dose dexamethasone orally on days 1-4 9-12 and 17-20 courses repeat every 35 days for a total of 3 courses Regimen B stem cell mobilization and collection Following a 4-6 week break after dexamethasone induction and regardless of response or progression patients have stem cells collected following administration of filgrastim G-CSF by injection G-CSF continues until completion of stem cell collection maximum of 6 aphereses Regimen C first peripheral blood stem cell transplant PBSCT Regardless of disease progression patients recovered from toxicities from dexamethasone induction and stem cell mobilization and collection and who have adequate number of CD34 cells collected for at least 1 transplant receive 1 dose of melphalan daily for 2 days followed by peripheral stem cell reinfusion G-CSF is given by injection beginning on the day after peripheral stem cell reinfusion and continues until the absolute granulocyte count is greater than 1000mm3 on 3 consecutive days Regimen D second PBSCT Patients who had adequate stem cell collection for 2 transplants during regimen B have no evidence of disease progression after the first transplant and have recovered from effects of previous treatment undergo a second treatment with high dose melphalan with PBSCT and G-CSF support given 3-12 months following the first transplant Patients who had enough cells collected for only one transplant go directly to regimen E Regimen E maintenance interferon alfa Beginning 5-12 weeks after transplant and upon hematologic recovery of blood counts and other toxicities patients with at least a partial response after high dose melphalan and PBSCT receive subcutaneous interferon alfa injections 3 times a week for 5 years or until disease progression relapse or toxicity Patients are followed every month for 6 months then every 3 months for 5 years then annually thereafter
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study over 4 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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S9805 | OTHER | None | None |