Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer

UNICANCER57 enrolled

Overview

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: This phase II trial is studying how well allogeneic stem cell transplant works in treating patients with metastatic kidney cancer.

OBJECTIVES: * Determine the 18-month survival rate of patients with metastatic renal cell carcinoma treated with allogeneic stem cell transplantation. * Determine the objective rate of response of patients treated with this regimen. * Determine post-transplant immunological reactions and recuperation of patients treated with this regimen. * Determine the antitumoral activity of this regimen in these patients. OUTLINE: This is a non-randomized, multicenter study. Patients are assigned to 1 of 2 treatment groups based on availability of a compatible family member for stem cell transplantation. * Group I: Patients with a compatible family donor receive conditioning chemotherapy comprising cyclophosphamide IV over 2 hours on days -7 and -6 and fludarabine IV once daily on days -5 to -1. Patients undergo filgrastim (G-CSF)-mobilized allogeneic stem cell transplantation on day 0. Patients also receive immunosuppression therapy with cyclosporine beginning on day -2. Patients who have persistent or progressive disease, mixed chimerism, and no evidence of grade 2 or greater graft-vs-host disease, and have been off immunosuppression therapy for 1-2 weeks receive donor lymphocyte infusion on days 7 and 21. * Group II: Patients without a compatible family donor receive treatment (immunotherapy, vaccination therapy, or chemotherapy) at the discretion of the treating physician. Patients are followed every 3 months for 5 years. PROJECTED ACCRUAL: A total of 170 patients (60 patients for group I and 110 patients for group II) will be accrued for this study within 3 years.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Kidney Cancer

Interventions

therapeutic allogeneic lymphocytesBIOLOGICAL

cyclophosphamideDRUG

cyclosporineDRUG

fludarabine phosphateDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed metastatic renal cell carcinoma * No sarcomatoid, pure papillary, or Bellini renal cell cancer * Measurable and/or evaluable disease * Disease progression after at least 1 immunotherapy regimen for metastatic disease * Localized metastases allowed provided the following are true: * At least 3 months since prior treatment for metastases * Not considered likely to influence outcome of transplantation * No brain metastases unless treated surgically or radiologically and MRI normal * Sufficiently healthy, HLA-compatible family member must be available as donor for patients undergoing stem cell transplantation PATIENT CHARACTERISTICS: Age * 18 to 65 Performance status * ECOG 0-1 Life expectancy * More than 6 months Hematopoietic * Platelet count at least 100,000/mm\^3 Hepatic * Transaminases less than 1.5 times upper limit of normal (ULN)\* * Bilirubin less than 1.5 times ULN\* NOTE: \*Unless due to Gilbert's disease Renal * No renal insufficiency * Calcium less than 10.4 mg/dL * Creatinine clearance greater than 50 mL/min Cardiovascular * Ejection fraction greater than 50% Pulmonary * No DLCO that would preclude fludarabine or busulfan therapy Other * Not pregnant or nursing * Fertile patients must use effective contraception * No physical obstacle to receiving study treatment * No known autoimmune disease * No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix * No uncontrolled bacterial, viral, or fungal infection * No prior or concurrent psychiatric disease * HIV negative * HTLV1 negative PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * No tolerance to fludarabine and busulfan Endocrine therapy * No concurrent corticosteroids Radiotherapy * Not specified Surgery * Not specified

Locations (26)

Centre Hospitalier Regional et Universitaire d'Angers

Angers, France

Outcomes

Primary Outcomes

Survival rate at 18 months

Objective rate of response

Post-transplant immunological reactions and recuperation

Antitumoral activity

Data from ClinicalTrials.gov

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