Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006126
Status:
WITHDRAWN
Last Update Posted:
2015-11-13
First Post:
2000-08-03
Brief Title:
Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung Breast Testicular or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Allogeneic Peripheral Blood Progenitor Cell Transplantation in Patients With Incurable Solid Tumors A Phase I Study
Status:
WITHDRAWN
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to accrue subjects
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 drugs and kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of peripheral stem cell transplantation in treating patients who have melanoma or small cell lung breast testicular or kidney cancer that is metastatic or that cannot be treated with surgery
PURPOSE Phase I trial to study the effectiveness of peripheral stem cell transplantation in treating patients who have melanoma or small cell lung breast testicular or kidney cancer that is metastatic or that cannot be treated with surgery
Detailed Description:
OBJECTIVES I Determine the toxicity of allogeneic peripheral blood stem cell transplantation in patients with metastatic or unresectable small cell lung cancer breast cancer testicular germ cell cancer melanoma or renal cell cancer II Determine the efficacy of this regimen in these patients
OUTLINE Donors receive filgrastim G-CSF subcutaneously for 4 or 5 days prior to peripheral blood stem cell harvest Patients are assigned to one of three conditioning regimens depending on disease Group A small cell lung cancer Patients receive cyclophosphamide IV over 1-2 hours on days -7 and -6 etoposide IV over 4 hours on day -5 and total body irradiation twice daily on days -4 to -1 Group B breast cancer and testicular germ cell cancer Patients receive oral busulfan every 6 hours on days -7 to -4 for a total of 14 doses Patients then receive cyclophosphamide IV over 1-2 hours on days -3 and -2 Group C renal cell cancer and melanoma Patients receive fludarabine IV daily on days -8 to -4 and cyclophosphamide IV on days -3 and -2 All groups Patients receive allogeneic peripheral blood stem cells IV over 10-20 minutes on day 0 Patients are followed weekly for 3 months at 6 and 12 months and then yearly for 5 years
PROJECTED ACCRUAL A total of 19-42 patients will be accrued for this study
OUTLINE Donors receive filgrastim G-CSF subcutaneously for 4 or 5 days prior to peripheral blood stem cell harvest Patients are assigned to one of three conditioning regimens depending on disease Group A small cell lung cancer Patients receive cyclophosphamide IV over 1-2 hours on days -7 and -6 etoposide IV over 4 hours on day -5 and total body irradiation twice daily on days -4 to -1 Group B breast cancer and testicular germ cell cancer Patients receive oral busulfan every 6 hours on days -7 to -4 for a total of 14 doses Patients then receive cyclophosphamide IV over 1-2 hours on days -3 and -2 Group C renal cell cancer and melanoma Patients receive fludarabine IV daily on days -8 to -4 and cyclophosphamide IV on days -3 and -2 All groups Patients receive allogeneic peripheral blood stem cells IV over 10-20 minutes on day 0 Patients are followed weekly for 3 months at 6 and 12 months and then yearly for 5 years
PROJECTED ACCRUAL A total of 19-42 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-G00-1838 | None | None | None |
| NU-99H2 | None | None | None |