Bethesda, Maryland 20892


Purpose:

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.


Study summary:

OBJECTIVES: - 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. OUTLINE: - 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.


Criteria:

DISEASE CHARACTERISTICS: - Histologically proven metastatic renal cell carcinoma not amenable to complete surgical resection and progressive despite immunotherapy - Bidimensionally evaluable clinically or radiographically - HLA 6/6 or 5/6 matched family donor available - No CNS metastases PATIENT CHARACTERISTICS: Age: - 18 to 80 Performance status: - ECOG 0 or 1 Life expectancy: - At least 3 months Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 4 mg/dL - Transaminases no greater than 3 times upper limit of normal Renal: - Creatinine no greater than 2.5 mg/dL - No malignancy-associated hypercalcemia (< 2.5 mmol/L) Cardiovascular: - Left ventricular ejection fraction greater than 40% Pulmonary: - DLCO greater than 65% of predicted Other: - Not pregnant - HIV negative - No major organ dysfunction that would preclude transplantation - No other malignancies except basal cell or squamous cell skin cancer - No psychiatric disorder or mental deficiency that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - At least 1 month since prior treatment for renal cell carcinoma


NCT ID:

NCT00003553


Primary Contact:

Study Chair
Richard W. Childs, MD
National Heart, Lung, and Blood Institute (NHLBI)


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States

Patient Recruitment
Phone: 800-411-1222

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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