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

This study has been completed.
Information provided by:
University of Rochester Identifier:
First received: December 6, 2005
Last updated: June 5, 2013
Last verified: June 2013

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.

Condition Intervention Phase
Kidney Cancer Biological: anti-thymocyte globulin Biological: graft-versus-tumor induction therapy Biological: therapeutic allogeneic lymphocytes Drug: cyclophosphamide Drug: fludarabine phosphate Drug: mycophenolate mofetil Drug: tacrolimus Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Phase 2

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-Myeloablative HLA-Matched Sibling Allogeneic Peripheral Blood Stem Cell Transplantation for Metastatic Renal Cell Carcinoma

Resource links provided by NLM:

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Response rate based on tumor measurements at 1 year

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 35
Study Start Date: August 2001
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)


Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • Not specified


  • Bilirubin < 3 mg/dL


  • Creatinine < 2 mg/dL
  • No untreated hypercalcemia


  • LVEF ≥ 40%


  • DLCO ≥ 40%


  • 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


  • At least 15 days since prior treatment for renal cell carcinoma
  • No other concurrent anticancer therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00262886

United States, New York
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Principal Investigator: J. J. Ifthikharuddin, MD James P. Wilmot Cancer Center
Principal Investigator: Jane L. Liesveld, MD James P. Wilmot Cancer Center
  More Information Identifier: NCT00262886     History of Changes
Other Study ID Numbers: CDR0000449939
Study First Received: December 6, 2005
Last Updated: June 5, 2013

Keywords provided by University of Rochester:
recurrent renal cell cancer
stage IV renal cell cancer

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Mycophenolate mofetil
Fludarabine phosphate
Antilymphocyte Serum
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Calcineurin Inhibitors
Enzyme Inhibitors processed this record on September 20, 2017