Peripheral Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT00003553|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 19, 2020
RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine, before a donor peripheral blood stem cell transplant helps stop the growth of tumor cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining tumor cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine with or without mycophenolate mofetil or methotrexate after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well peripheral stem cell transplant works in treating patients with metastatic kidney cancer.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Other: HLA Matched Peripheral BLood Stem Cells||Phase 2|
- Determine the antitumor effect of allogeneic peripheral blood stem cell transplantation (PBSCT) in patients with metastatic renal cell carcinoma.
- Evaluate the safety and toxicity of a nonmyeloablative, low-intensity, preparative regimen followed by an HLA-matched allogeneic PBSCT in these patients.
- Determine engraftment by measuring donor-recipient chimerism in lymphoid and myeloid lineages in patients treated with this regimen.
- Determine the relationship between donor-host chimerism and the incidence of acute and chronic graft-versus-host disease in patients treated with this regimen.
- Determine the effect of lymphocyte infusions on donor-host chimerism in this patient population.
- Determine the response rate, disease-free survival, overall survival, and mortality from the procedure or tumor progression in patients treated with this regimen.
Nonmyeloablative preparative regimen: Patients receive 1 of 3 preparative regimens prior to peripheral blood progenitor cell (PBPC) transplantation. (Regimens 2 and 3 closed to accrual as of 10/1/03.)
- Regimen 1: Patients receive cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes on days -5 to -1.
- Regimen 2 (closed to accrual as of 10/1/03): Patients receive cyclophosphamide IV over 1 hour on days -7 and -6, fludarabine IV over 30 minutes on days -5 to -1, and antithymocyte globulin on days -5 to -2.
- Regimen 3 (closed to accrual as of 10/1/03): Patients receive cyclophosphamide IV over 1 hour on days -8 to -6, fludarabine IV over 30 minutes on days -5 to -1, and antithymocyte globulin on days -5 to -2.
- PBPC transplantation: Patients undergo mobilized CD34+ PBPC transplantation on day 0. PBPC transplantation may be repeated on days 1 and 2, if deemed necessary.
Graft-versus-host disease (GVHD) prophylaxis: Patients receive 1 of 3 GVHD prophylaxis regimens.
- Regimen 1 (closed to accrual as of 10/17/00): Patients receive cyclosporine IV over 12 hours or orally beginning on day -4 and continuing for up to approximately 3 months.
- Regimen 2 (open to accrual from 10/17/00 through 2/11/02): Patients receive cyclosporine as in regimen 1. Patients also receive mycophenolate mofetil.
- Regimen 3 (open to accrual as of 2/11/02): Patients receive cyclosporine as in regimen 1. Patients also receive methotrexate.
- Donor lymphocyte infusions: Patients with progressive disease on days 15-30, day 60, or day 100, without GVHD, receive infusion(s) of donor lymphocytes. Further donor lymphocyte infusions after day 100 may be given at the discretion of the attending physician.
Patients are followed every 2 months for 6 months, every 3 months for 2 years, and then every 6 months for 2½ years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||156 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||patients with progressive metastatic renal cell carcinoma.|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of HLA-Matched Peripheral Blood Mobilized Hematopoietic Progenitor Cell Transplantation for Metastatic Renal Cell Carcinoma Followed by Allogeneic T-Cell Infusion as Adoptive Immunotherapy|
|Actual Study Start Date :||February 9, 1998|
|Actual Primary Completion Date :||June 27, 2011|
|Actual Study Completion Date :||June 27, 2011|
The target for progenitor cell is >=5 x 106 CD 34/kg.
Other: HLA Matched Peripheral BLood Stem Cells
- The anti-tumor effect of allogenic peripheral blood stem cell transplantation in patients with progressive metastatic renal cell carcinoma. [ Time Frame: 5 Years ]
- Evaluate the safety and toxicity of a nonmyeloblative, low intensity, preparative regimen followed by an HLA matched allogenic peripheral blood stem cell transplant in patients with metastatic renal cell carcinoma. [ Time Frame: 100 Days ]
- The relationship between donor-host chimerism and the incidence of acute and chronic GVHD. The effect of donor lymphocyte infusions on donor-host chimerism. Response rate, disease free and overall survival and mortality. [ Time Frame: 100 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003553
|United States, Maryland|
|NIH - Warren Grant Magnuson Clinical Center|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||Richard W. Childs, MD||National Heart, Lung, and Blood Institute (NHLBI)|