Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025519
Status:
WITHDRAWN
Last Update Posted:
2013-07-11
First Post:
2001-10-11
Brief Title:
Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Recurrent Kidney Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Submyeloablative Allogeneic Blood Stem Cell Transplantation With HLA Identical Donor Lymphocyte Infusions From Matched Related and Matched Unrelated Donors for Treatment of Metastatic Renal Cell Carcinoma
Status:
WITHDRAWN
Status Verified Date:
2013-07
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 Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill cancer cells Sometimes the transplanted cells can be rejected by the bodys tissues Mycophenolate mofetil tacrolimus and donor white blood cells may prevent this from happening
PURPOSE Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have metastatic or recurrent kidney cancer
PURPOSE Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have metastatic or recurrent kidney cancer
Detailed Description:
OBJECTIVES
Determine the feasibility of submyeloablative HLA-identical allogeneic peripheral blood stem cell transplantation in patients with metastatic or recurrent renal cell carcinoma
Determine the toxicity of this regimen in terms of incidence and severity of graft rejection acute graft-vs-host disease GVHD chronic GVHD adverse effects from the preparative regimen and thalidomide and infection and bleeding in these patients
Determine the efficacy of this regimen in terms of objective partial and complete response rates in these patients
Determine the engraftment rates and extent of chimerism in patients treated with this regimen
Determine the overall survival and time to treatment failure rate in patients treated with this regimen
Determine the impact of thalidomide on the treatment of chronic GVHD in patients treated with this regimen
OUTLINE Patients are stratified according to risk low vs high
Patients receive fludarabine IV over 30 minutes once daily on days -4 to -2 followed by total body irradiation on day -1 Patients receive tacrolimus IV over 24 hours or orally daily on days -3 to 35 and oral mycophenolate mofetil twice daily on days -3 to 28 as graft-vs-host disease GVHD prophylaxis Patients undergo allogeneic peripheral blood stem cell transplantation over 1-2 hours on day 0
Patients maintaining a mixed chimerism with no evidence of grade III or IV GVHD receive donor lymphocyte infusions DLI on days 60 90 and 120 Patients may receive additional DLI as needed Patients with limited chronic GVHD receive oral thalidomide daily beginning after day 80 and continuing for 1 year or until disease progression or resolution of chronic GVHD
Patients are followed at 1 3 6 and 12 months and then every 6 months thereafter
PROJECTED ACCRUAL A maximum of 20-40 patients 10-20 per stratum will be accrued for this study
Determine the feasibility of submyeloablative HLA-identical allogeneic peripheral blood stem cell transplantation in patients with metastatic or recurrent renal cell carcinoma
Determine the toxicity of this regimen in terms of incidence and severity of graft rejection acute graft-vs-host disease GVHD chronic GVHD adverse effects from the preparative regimen and thalidomide and infection and bleeding in these patients
Determine the efficacy of this regimen in terms of objective partial and complete response rates in these patients
Determine the engraftment rates and extent of chimerism in patients treated with this regimen
Determine the overall survival and time to treatment failure rate in patients treated with this regimen
Determine the impact of thalidomide on the treatment of chronic GVHD in patients treated with this regimen
OUTLINE Patients are stratified according to risk low vs high
Patients receive fludarabine IV over 30 minutes once daily on days -4 to -2 followed by total body irradiation on day -1 Patients receive tacrolimus IV over 24 hours or orally daily on days -3 to 35 and oral mycophenolate mofetil twice daily on days -3 to 28 as graft-vs-host disease GVHD prophylaxis Patients undergo allogeneic peripheral blood stem cell transplantation over 1-2 hours on day 0
Patients maintaining a mixed chimerism with no evidence of grade III or IV GVHD receive donor lymphocyte infusions DLI on days 60 90 and 120 Patients may receive additional DLI as needed Patients with limited chronic GVHD receive oral thalidomide daily beginning after day 80 and continuing for 1 year or until disease progression or resolution of chronic GVHD
Patients are followed at 1 3 6 and 12 months and then every 6 months thereafter
PROJECTED ACCRUAL A maximum of 20-40 patients 10-20 per stratum 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-G01-2021 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068970 | REGISTRY | None | None |
| TUHSC-3721 | None | None | None |