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Non-Myeloablative HLA-Matched Sibling Allogeneic Peripheral Blood Stem Cell Transplantation for Metastatic Renal Cell Carcinoma


Phase 2
18 Years
70 Years
Not Enrolling
Both
Kidney Cancer

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Trial Information

Non-Myeloablative HLA-Matched Sibling Allogeneic Peripheral Blood Stem Cell Transplantation for Metastatic Renal Cell Carcinoma


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate based on tumor measurements at 1 year

Safety Issue:

No

Principal Investigator

J. J. Ifthikharuddin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

James P. Wilmot Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000449939

NCT ID:

NCT00262886

Start Date:

August 2001

Completion Date:

Related Keywords:

  • Kidney Cancer
  • recurrent renal cell cancer
  • stage IV renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642