Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer
NCT ID: NCT00056095
Last Updated: 2021-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
57 participants
INTERVENTIONAL
2002-11-04
2016-08-17
Brief Summary
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PURPOSE: This phase II trial is studying how well allogeneic stem cell transplant works in treating patients with metastatic kidney cancer.
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Allograft (compatible family member)
therapeutic allogeneic lymphocytes
cyclophosphamide
cyclosporine
fludarabine phosphate
allogeneic bone marrow transplantation
peripheral blood stem cell transplantation
Allograft (compatible non-family member)
allogeneic bone marrow transplantation
peripheral blood stem cell transplantation
Interventions
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therapeutic allogeneic lymphocytes
cyclophosphamide
cyclosporine
fludarabine phosphate
allogeneic bone marrow transplantation
peripheral blood stem cell transplantation
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Didier Blaise, MD
Role: STUDY_CHAIR
Institut Paoli-Calmettes
Locations
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Centre Hospitalier Regional et Universitaire d'Angers
Angers, , France
Centre Paul Papin
Angers, , France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, , France
Hopital Saint Andre
Bordeaux, , France
Chu-Hopital Gabriel Montpied
Clermont-Ferrand, , France
Centre Jean Perrin
Clermont-Ferrand, , France
CHU de Grenoble - Hopital Michallon
Grenoble, , France
Centre Oscar Lambret
Lille, , France
Centre Hospital Universitaire Hop Huriez
Lille, , France
Centre Hospital Regional Universitaire de Limoges
Limoges, , France
Centre Leon Berard
Lyon, , France
Hopital Edouard Herriot - Lyon
Lyon, , France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, , France
Hopital Lapeyronie-CHU Montpellier
Montpellier, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , France
Centre Antoine Lacassagne
Nice, , France
Hopital de l'Archet CHU de Nice
Nice, , France
Institut Curie Hopital
Paris, , France
Hopital Haut Leveque
Pessac, , France
Hopital Jean Bernard
Poitiers, , France
Centre Hospitalier Universitaire de Rennes
Rennes, , France
Centre Eugene Marquis
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Hopitaux de Brabois
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Other Identifiers
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FRE-FNCLCC-GETUG-11/0105
Identifier Type: OTHER
Identifier Source: secondary_id
EU-20234
Identifier Type: OTHER
Identifier Source: secondary_id
UC-0160/0105
Identifier Type: -
Identifier Source: org_study_id
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