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

NCT ID: NCT00262886

Last Updated: 2013-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-08-31

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.

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.

Conditions

Kidney Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

anti-thymocyte globulin

Intervention Type: BIOLOGICAL

graft-versus-tumor induction therapy

Intervention Type: BIOLOGICAL

therapeutic allogeneic lymphocytes

Intervention Type: BIOLOGICAL

cyclophosphamide

Intervention Type: DRUG

fludarabine phosphate

Intervention Type: DRUG

mycophenolate mofetil

Intervention Type: DRUG

tacrolimus

Intervention Type: DRUG

allogeneic bone marrow transplantation

Intervention Type: PROCEDURE

peripheral blood stem cell transplantation

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Principal Investigators

J. J. Ifthikharuddin, MD

Role: PRINCIPAL_INVESTIGATOR

James P. Wilmot Cancer Center

Jane L. Liesveld, MD

Role: PRINCIPAL_INVESTIGATOR

James P. Wilmot Cancer Center

Locations

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

Rochester, New York, United States

Countries

United States

Other Identifiers

URCC-U1801

Identifier Type: -

Identifier Source: secondary_id

URCC-RSRB-09084

Identifier Type: -

Identifier Source: secondary_id

CDR0000449939

Identifier Type: -

Identifier Source: org_study_id