Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003490
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Following GM-CSF in Treating Patients With Multiple Myeloma
Sponsor:
The Cleveland Clinic
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II to Treat Multiple Myeloma Patients With Cytoxan and Vincristine After Cycling Myeloma Cells With rHuGM-CSF
Status:
COMPLETED
Status Verified Date:
2001-03
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 GM-CSF may make cancer cells more sensitive to the effects of chemotherapy Combining more than one drug with GM-CSF may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy consisting of cyclophosphamide plus vincristine following GM-CSF in treating patients with multiple myeloma that has not responded to previous treatment
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy consisting of cyclophosphamide plus vincristine following GM-CSF in treating patients with multiple myeloma that has not responded to previous treatment
Detailed Description:
OBJECTIVES I Determine the response rate of multiple myeloma patients when treated with cyclophosphamide and vincristine after cycling myeloma cells with sargramostim GM-CSF II Evaluate whether Labelling Index LI changes influenced by GM-CSF would predict a group of patients that will respond to this particular course specific design III Determine the toxicity of GM-CSF in these patients
OUTLINE Patients receive subcutaneous injections of sargramostim GM-CSF once a day for 5 days Two to 3 days later patients receive cyclophosphamide IV over 30-45 minutes on day 1 vincristine IV bolus on day 8 and oral prednisone 4 times a day on days 1-4 Patients also receive subcutaneous injections of GM-CSF starting on day 2 and continuing for 10 days or until neutrophil count is at least 1000mm3 Treatment continues every 3 weeks for a minimum of 6 courses in the absence of disease progression or unacceptable toxicity Patients who achieve at least stable response receive GM-CSF 3 times a week for up to 2 years Patients are followed every 3-6 months
PROJECTED ACCRUAL A maximum of 30 patients will be accrued
OUTLINE Patients receive subcutaneous injections of sargramostim GM-CSF once a day for 5 days Two to 3 days later patients receive cyclophosphamide IV over 30-45 minutes on day 1 vincristine IV bolus on day 8 and oral prednisone 4 times a day on days 1-4 Patients also receive subcutaneous injections of GM-CSF starting on day 2 and continuing for 10 days or until neutrophil count is at least 1000mm3 Treatment continues every 3 weeks for a minimum of 6 courses in the absence of disease progression or unacceptable toxicity Patients who achieve at least stable response receive GM-CSF 3 times a week for up to 2 years Patients are followed every 3-6 months
PROJECTED ACCRUAL A maximum of 30 patients will be accrued
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-V98-1458 | None | None | None |
| CCF-IRB-1863 | None | None | None |
| IMMUNEX-0010743 | None | None | None |