Clinical trial NCT00056095: Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer
Official title: Phase II Trial in Intrafamilial Allogeneic Cell Transplant in Patients With Metastatic Kidney Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Cancer
Keywords: recurrent renal cell cancer
stage IV renal cell cancer
Lead sponsor: UNICANCER
Sponsor class: OTHER
First posted: 2003-03-07
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival rate at 18 months
measure: Objective rate of response
measure: Post-transplant immunological reactions and recuperation
measure: Antitumoral activity
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Hospitalier Regional et Universitaire d'Angers
city: Angers
country: France
facility: Centre Paul Papin
city: Besancon
country: France
facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
city: Bordeaux
country: France
facility: Hopital Saint Andre
city: Clermont-Ferrand
country: France
facility: Chu-Hopital Gabriel Montpied
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Grenoble
country: France
facility: CHU de Grenoble - Hopital Michallon
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: Centre Hospital Universitaire Hop Huriez
city: Limoges
country: France
facility: Centre Hospital Regional Universitaire de Limoges
city: Lyon
country: France
facility: Centre Leon Berard
city: Lyon
country: France
facility: Hopital Edouard Herriot - Lyon
city: Marseille
country: France
facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
city: Montpellier
country: France
facility: Hopital Lapeyronie-CHU Montpellier
city: Montpellier
country: France
facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Nice
country: France
facility: Hopital de l'Archet CHU de Nice
city: Paris
country: France
facility: Institut Curie Hopital
city: Pessac
country: France
facility: Hopital Haut Leveque
city: Poitiers
country: France
facility: Hopital Jean Bernard
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Vandoeuvre-les-Nancy
country: France
facility: Centre Alexis Vautrin
city: Vandoeuvre-Les-Nancy
country: France
facility: Hopitaux de Brabois
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Institut Paoli-Calmettes
name: Didier Blaise, MD
role: STUDY_CHAIR
References: