Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002552
Status:
COMPLETED
Last Update Posted:
2013-04-09
First Post:
1999-11-01
Brief Title:
Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Refractory Non-Hodgkins Lymphoma Hodgkins Disease or Multiple Myeloma
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
AUTOLOGOUS ALLOGENEIC OR SYNGENEIC BONE MARROW TRANSPLANTATION IN HODGKINS DISEASE NON-HODGKINS LYMPHOMA AND MULTIPLE MYELOMA
Status:
COMPLETED
Status Verified Date:
2013-04
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 tumor cells from dividing so they stop growing or die Combining bone marrow transplantation with chemotherapy may allow doctors to give higher doses of chemotherapy and kill more tumor cells
PURPOSE This phase II trial is studying the side effects of giving a bone marrow transplant together with chemotherapy and to see how well it works in treating patients with refractory non-Hodgkins lymphoma Hodgkins lymphoma or multiple myeloma
PURPOSE This phase II trial is studying the side effects of giving a bone marrow transplant together with chemotherapy and to see how well it works in treating patients with refractory non-Hodgkins lymphoma Hodgkins lymphoma or multiple myeloma
Detailed Description:
OBJECTIVES I Assess the toxicities response rate and duration of response associated with high-dose cyclophosphamide etoposide carmustine or high-dose cyclophosphamide and total-body irradiation followed by autologous allogeneic or syngeneic bone marrow transplant in patients with refractory or high-risk non-Hodgkins lymphoma Hodgkins disease or multiple myeloma II Evaluate any prognostic factors
OUTLINE Patients with prior radiotherapy greater than 2000 cGy receive cyclophosphamide IV over 2 hours and etoposide IV over at least 30 minutes on days -7 through -4 followed by carmustine IV over 2 hours on day -3 Patients receive allogeneic or autologous bone marrow transplantation on day 0 Patients with or without prior radiotherapy less than 2000 cGy receive cyclophosphamide IV over 2 hours on days -8 through -5 followed by total body irradiation on days -4 through -1 Patients receive allogeneic or autologous bone marrow transplantation on day 0 Prior to autologous bone marrow transplantation and following myeloablative chemotherapy patients undergo mobilization consisting of cytarabine subcutaneously every 12 hours for 6 doses Approximately 24 hours later patients receive sargramostim GM-CSF subcutaneously Peripheral blood stem cells are collected every 1-3 days beginning when blood counts recover and continuing until sufficient number of cells are reached
PROJECTED ACCRUAL Approximately 40 patients will be accrued for this study
OUTLINE Patients with prior radiotherapy greater than 2000 cGy receive cyclophosphamide IV over 2 hours and etoposide IV over at least 30 minutes on days -7 through -4 followed by carmustine IV over 2 hours on day -3 Patients receive allogeneic or autologous bone marrow transplantation on day 0 Patients with or without prior radiotherapy less than 2000 cGy receive cyclophosphamide IV over 2 hours on days -8 through -5 followed by total body irradiation on days -4 through -1 Patients receive allogeneic or autologous bone marrow transplantation on day 0 Prior to autologous bone marrow transplantation and following myeloablative chemotherapy patients undergo mobilization consisting of cytarabine subcutaneously every 12 hours for 6 doses Approximately 24 hours later patients receive sargramostim GM-CSF subcutaneously Peripheral blood stem cells are collected every 1-3 days beginning when blood counts recover and continuing until sufficient number of cells are reached
PROJECTED ACCRUAL Approximately 40 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 |
|---|---|---|---|
| NCI-V94-0364 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |
| P30CA022453 | NIH | None | None |
| WSU-D-701-87 | None | None | None |