Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004135
Status:
COMPLETED
Last Update Posted:
2014-03-07
First Post:
1999-12-10
Brief Title:
Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Metastatic Kidney Cancer
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Allogeneic Stem Cell Transplantation of Renal Cell Cancer and Metastatic Melanoma After Non-Myeloablative Chemotherapy
Status:
COMPLETED
Status Verified Date:
2014-03
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 Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells
PURPOSE Phase II trial to study the effectiveness of chemotherapy plus peripheral stem cell transplantation in treating patients who have metastatic kidney cancer or melanoma
PURPOSE Phase II trial to study the effectiveness of chemotherapy plus peripheral stem cell transplantation in treating patients who have metastatic kidney cancer or melanoma
Detailed Description:
OBJECTIVES
Evaluate the safety of nonmyeloablative chemotherapy followed by allogeneic peripheral blood stem cell transplantation in patients with metastatic renal cell carcinoma or melanoma
Determine the incidence and severity of all adverse events related to this treatment regimen in this patient population
Determine the efficacy of this treatment regimen in terms of tumor regression response duration progression free survival and overall survival in these patients
Measure the resulting chimerism and immune reconstitution in these patients after this treatment regimen and correlate with clinical response
OUTLINE Patients receive fludarabine IV over 30 minutes on days -8 through -4 and cyclophosphamide IV over 1 hour on days -3 and -2 Immediately following each daily donor leukapheresis patients receive allogeneic peripheral blood stem cells PBSC IV over 15 minutes beginning on day 0 and continuing until the target cells are collected Patients receive filgrastim G-CSF subcutaneously beginning on day 5 and continuing until blood counts recover
If no graft versus host disease has developed within 4 weeks of allogeneic PBSC transplantation patients with disease progression or recurrence who have residual donor hematopoiesis on chimerism analysis may receive donor T lymphocytes IV over 30 minutes Patients may receive an additional course of donor T lymphocytes at the investigators discretion
Patients are followed at days 30 and 100 and then every 3 months thereafter
PROJECTED ACCRUAL A total of 10-38 patients will be accrued for this study within 25 years
Evaluate the safety of nonmyeloablative chemotherapy followed by allogeneic peripheral blood stem cell transplantation in patients with metastatic renal cell carcinoma or melanoma
Determine the incidence and severity of all adverse events related to this treatment regimen in this patient population
Determine the efficacy of this treatment regimen in terms of tumor regression response duration progression free survival and overall survival in these patients
Measure the resulting chimerism and immune reconstitution in these patients after this treatment regimen and correlate with clinical response
OUTLINE Patients receive fludarabine IV over 30 minutes on days -8 through -4 and cyclophosphamide IV over 1 hour on days -3 and -2 Immediately following each daily donor leukapheresis patients receive allogeneic peripheral blood stem cells PBSC IV over 15 minutes beginning on day 0 and continuing until the target cells are collected Patients receive filgrastim G-CSF subcutaneously beginning on day 5 and continuing until blood counts recover
If no graft versus host disease has developed within 4 weeks of allogeneic PBSC transplantation patients with disease progression or recurrence who have residual donor hematopoiesis on chimerism analysis may receive donor T lymphocytes IV over 30 minutes Patients may receive an additional course of donor T lymphocytes at the investigators discretion
Patients are followed at days 30 and 100 and then every 3 months thereafter
PROJECTED ACCRUAL A total of 10-38 patients will be accrued for this study within 25 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 |
|---|---|---|---|
| NCI-G99-1612 | None | None | None |
| UCCRC-9672 | None | None | None |
| UCCRC-CTRC-9866 | None | None | None |