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

This study has been completed.
Sponsor:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00262886
First received: December 6, 2005
Last updated: June 5, 2013
Last verified: June 2013

December 6, 2005
June 5, 2013
August 2001
July 2007   (final data collection date for primary outcome measure)
Response rate based on tumor measurements at 1 year [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00262886 on ClinicalTrials.gov Archive Site
  • Toxicity as measured by NCI CTC at days 0, 7, 14, 21 and 28 after transplantation and monthly for 11 months [ Designated as safety issue: Yes ]
  • Overall and disease-free survival at day 100 and 1 year after transplantation [ Designated as safety issue: No ]
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Donor Peripheral Stem Cell or Bone Marrow Transplant in Treating Patients With Relapsed or Refractory Metastatic Kidney Cancer
Non-Myeloablative HLA-Matched Sibling Allogeneic Peripheral Blood Stem Cell Transplantation for Metastatic Renal Cell Carcinoma

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
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July 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00262886
CDR0000449939, URCC-U1801, URCC-RSRB-09084
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Not Provided
University of Rochester
Not Provided
Principal Investigator: J. J. Ifthikharuddin, MD James P. Wilmot Cancer Center
Principal Investigator: Jane L. Liesveld, MD James P. Wilmot Cancer Center
University of Rochester
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP