Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer
Conditions
Kidney Cancer
Conditions: official terms
Carcinoma, Renal Cell - Kidney Neoplasms
Conditions: Keywords
recurrent renal cell cancer, stage IV renal cell cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Primary Purpose: Treatment
Intervention
Name: therapeutic allogeneic lymphocytes Type: Biological
Name: cyclophosphamide Type: Drug
Name: cyclosporine Type: Drug
Name: fludarabine phosphate Type: Drug
Name: allogeneic bone marrow transplantation Type: Procedure
Name: peripheral blood stem cell transplantation Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both
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
Locations
Centre Hospitalier Regional et Universitaire d'Angers
Angers, France
Status: Recruiting
Contact: Norbert Ifrah, MD - 33-2-41-35-4472
Centre Paul Papin
Angers, France
Status: Recruiting
Contact: Remy Delva - 33-49-800-918-507
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besancon, France
Status: Recruiting
Contact: Contact Person - 33-81-668-240
Hopital Saint Andre
Bordeaux, France
Status: Recruiting
Contact: Alain Ravaud, MD, PhD - 33-5-5679-5808 - alain.ravaud@chu-bordeaux.fr
Centre Jean Perrin
Clermont-Ferrand, France
Status: Recruiting
Contact: Jean Olivier - 33-73-278-080
Chu-Hopital Gabriel Montpied
Clermont-Ferrand, France
Status: Recruiting
Contact: Laurent Guy, MD - 33-0473-750-750 - lguy@chu-clermontferrand.fr
CHU de Grenoble - Hopital Michallon
Grenoble, France
Status: Recruiting
Contact: Frederic Garban, MD, PhD - 33-4-7676-5028
Centre Hospital Universitaire Hop Huriez
Lille, France
Status: Recruiting
Contact: J.P. Jouet, MD - 33 3 20 444197 - jpjouet@chru-lille.fr
Centre Oscar Lambret
Lille, France
Status: Recruiting
Contact: Armelle Caty, MD - 33-32-029-5959 - acaty@o-lambret.fr
Centre Hospital Regional Universitaire de Limoges
Limoges, France
Status: Recruiting
Contact: Dominique Bordessoule, MD, PhD - 33-5-5505-6642 - bordessoule@unilim.fr
Centre Leon Berard
Lyon, France
Status: Recruiting
Contact: Sylvie Negrier, MD - 33-4-7878-2751 - negrier@lyon.fnclcc.fr
Hopital Edouard Herriot - Lyon
Lyon, France
Status: Recruiting
Contact: Mauricette Michallet, MD - 33-472117401
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France
Status: Recruiting
Contact: Didier Blaise, MD - 33-4-91-22-37-54 - blaised@marseille.fnclcc.fr
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France
Status: Recruiting
Contact: Stephane Culine, MD - 33-4-6761-3755 - stculine@valdorel.fnclcc.fr
Hopital Lapeyronie-CHU Montpellier
Montpellier, France
Status: Recruiting
Contact: Eric Legouffe, MD - 33-4-67-33-80-79 - e-legouffe@chu-montpellier.fr
Centre Antoine Lacassagne
Nice, France
Status: Recruiting
Contact: Antoine Thyss, MD - 33-04-9203-1538 - antoine.thyss@cal.nice.fnclcc.fr
Hopital de l'Archet CHU de Nice
Nice, France
Status: Recruiting
Contact: Contact Person - 33-49-203-9267
Institut Curie Hopital
Paris, France
Status: Recruiting
Contact: Pierre T. Dorval, MD - 33-1-44-324-679 - thierry.dorval@curie.net
Hopital Haut Leveque
Pessac, France
Status: Recruiting
Contact: Reza Tabrizi, MD - 33-57-656-511
Hopital Jean Bernard
Poitiers, France
Status: Recruiting
Contact: Jean-Marc Tourani, MD - 33-549-444-534 - jm.tourani@chu.poitiers.frs.fr
Centre Eugene Marquis
Rennes, France
Status: Recruiting
Contact: Brigitte Laguerre - 33-2-9925-3000
Centre Hospitalier Universitaire de Rennes
Rennes, France
Status: Recruiting
Contact: Thiery Lamy, MD, PhD - 33-2-99-28-42-91 - thierry.lamy@univ-rennes1.fr
Centre Henri Becquerel
Rouen, France
Status: Recruiting
Contact: Nathalie Contentin - 33-2-3208-2222
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France
Status: Recruiting
Contact: Lionnel Geoffrois, MD - 33-3-8359-8400
Hopitaux de Brabois
Vandoeuvre-Les-Nancy, France
Status: Recruiting
Contact: Pierre Bordigoni - Not Available
Institut Gustave Roussy
Villejuif, France
Status: Recruiting
Contact: Jean-Henri Bourhis, MD, PhD - 33-1-42-11-4507 - jhb@igr.fr
Start Date
December 2002
Sponsors
UNICANCER
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page