Donor Peripheral Stem Cell or Bone Marrow Transplant in Treating Patients With Relapsed or Refractory Metastatic Kidney Cancer

University of Rochester35 enrolled

Overview

RATIONALE: A peripheral stem cell transplant or bone marrow transplant from a brother or sister may be an effective treatment for kidney cancer. PURPOSE: This phase II trial is studying how well a donor peripheral stem cell or bone marrow transplant works in treating patients with relapsed or refractory metastatic kidney cancer.

OBJECTIVES: * Determine the efficacy of nonmyeloablative sibling allogeneic peripheral blood stem cell transplantation in patients with relapsed or refractory metastatic renal cell carcinoma. * Determine the toxic effects of this regimen in these patients. OUTLINE: This is a pilot study. * Conditioning regimen: Patients receive cyclophosphamide IV on days -7 and -6 and fludarabine IV on days -5 to -1. Patients receiving 5/6-mismatched cells also receive anti-thymocyte globulin IV on days -5 to -3. * Allogeneic peripheral blood stem cell (PBSC) infusion: Patients undergo allogeneic PBSC or bone marrow transplantation on day 0. * Graft-versus-host disease (GVHD) prophylaxis: Patients receive oral mycophenolate mofetil twice daily on days 0-30. Patients receive tacrolimus IV continuously or orally twice daily beginning on day -2 and continuing up to day 44-100 in the absence of GVHD. * Donor lymphocyte infusion: Patients with partial or complete T-cell chimerism receive up to 3 donor lymphocyte infusions in the absence of GVHD or progressive disease. After completion of study treatment, patients are evaluated periodically for 3 years. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Kidney Cancer

Interventions

anti-thymocyte globulinBIOLOGICAL

graft-versus-tumor induction therapyBIOLOGICAL

therapeutic allogeneic lymphocytesBIOLOGICAL

cyclophosphamideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed metastatic renal cell carcinoma * Relapsed or refractory disease * Tumor not amenable to complete surgical resection * No bone metastases only * No untreated brain metastases * Measurable disease * Available sibling donor who is HLA-identical or who has a mismatch at a single HLA locus (i.e., a 6/6 or 5/6 match at the HLA-A, -B, and -DR loci) PATIENT CHARACTERISTICS: Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin \< 3 mg/dL Renal * Creatinine \< 2 mg/dL * No untreated hypercalcemia Cardiovascular * LVEF ≥ 40% Pulmonary * DLCO ≥ 40% Other * Not pregnant or nursing * Fertile patients must use effective contraception * Negative pregnancy test * HIV-1 and -2 negative * No uncontrolled infection * No other active malignancy except basal skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: * At least 15 days since prior treatment for renal cell carcinoma * No other concurrent anticancer therapy

Locations (1)

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, United States

Outcomes

Primary Outcomes

Response rate based on tumor measurements at 1 year

Secondary Outcomes

Toxicity as measured by NCI CTC at days 0, 7, 14, 21 and 28 after transplantation and monthly for 11 months

Overall and disease-free survival at day 100 and 1 year after transplantation

Data from ClinicalTrials.gov

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