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

Sponsor

University of Rochester (Other)

Overall Status

Completed

CT.gov ID

NCT00262886

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	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

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

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

Study Start Date :

Aug 1, 2001

Actual Primary Completion Date :

Jul 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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