Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003060
Status:
TERMINATED
Last Update Posted:
2020-06-30
First Post:
1999-11-01
Brief Title:
Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Metastatic Melanoma
Sponsor:
Louisiana State University Health Sciences Center Shreveport
Organization:
Louisiana State University Health Sciences Center Shreveport
Study Overview
Official Title:
Pilot Study for Matched-Related Allogeneic Bone Marrow Transplantation for Metastatic Malignant Melanoma
Status:
TERMINATED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of patient accrual
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 bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Clinical trial to study the effectiveness of chemotherapy plus bone marrow transplantation in treating patients with metastatic melanoma that has not responded to previous therapy
PURPOSE Clinical trial to study the effectiveness of chemotherapy plus bone marrow transplantation in treating patients with metastatic melanoma that has not responded to previous therapy
Detailed Description:
OBJECTIVES I Determine the response rate and survival of patients with metastatic malignant melanoma who have failed first-line therapy when treated with match-related allogeneic bone marrow transplantation
OUTLINE This is a pilot study Patients receive a preparative regimen of busulfan and cyclophosphamide Busulfan PO is administered every 6 hours on days -7 to -4 Cyclophosphamide IV is administered on days -3 to -2 followed by one day of rest Bone marrow infusion occurs on day 0 Cyclosporine begins on day -1 and continues until day 180 Methotrexate IV is administered on days 1 3 6 and 11 Granulocyte colony-stimulating factor is administered as a continuous IV every 2 hours starting on day 12 and continuing until absolute neutrophil count is greater than 1000 gdL for 2 consecutive days Patients receive weekly follow up for the first 180 days and monthly thereafter Patients are followed until death
PROJECTED ACCRUAL 6 patients with melanoma will be accrued
OUTLINE This is a pilot study Patients receive a preparative regimen of busulfan and cyclophosphamide Busulfan PO is administered every 6 hours on days -7 to -4 Cyclophosphamide IV is administered on days -3 to -2 followed by one day of rest Bone marrow infusion occurs on day 0 Cyclosporine begins on day -1 and continues until day 180 Methotrexate IV is administered on days 1 3 6 and 11 Granulocyte colony-stimulating factor is administered as a continuous IV every 2 hours starting on day 12 and continuing until absolute neutrophil count is greater than 1000 gdL for 2 consecutive days Patients receive weekly follow up for the first 180 days and monthly thereafter Patients are followed until death
PROJECTED ACCRUAL 6 patients with melanoma 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-V97-1318 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000065722 | REGISTRY | None | None |