Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 to 65	Other	FRE-FNCLCC-GETUG-11/0105 EU-20234, NCT00056095

Objectives

1. Determine the 18-month survival rate of patients with metastatic renal cell carcinoma treated with allogeneic stem cell transplantation.
2. Determine the objective rate of response of patients treated with this regimen.
3. Determine post-transplant immunological reactions and recuperation of patients treated with this regimen.
4. Determine the antitumoral activity of this regimen in these patients.

Entry 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

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

Patient Characteristics:

Age

• 18 to 65

Performance status

• ECOG 0-1

Life expectancy

• More than 6 months

Hematopoietic

• Platelet count at least 100,000/mm³

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

Expected Enrollment

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.

Outcomes

Survival rate at 18 months
Objective rate of response
Post-transplant immunological reactions and recuperation
Antitumoral activity

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.

Trial Contact Information

Trial Lead Organizations

Federation Nationale des Centres de Lutte Contre le Cancer

Didier Blaise, MD, Protocol chair		Ph: 33-4-91-22-37-54 Email: blaised@marseille.fnclcc.fr

France
	Angers
	Centre Hospitalier Regional et Universitaire d'Angers
		Norbert Ifrah, MD	Ph:  33-2-41-35-4472
	Centre Paul Papin
		Remy Delva	Ph:  33-49-800-918-507
	Besancon
	Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
		Contact Person	Ph:  33-81-668-240
		Fabrice Larosa	Ph:  33-3-7166-8232
	Bordeaux
	Hopital Saint Andre
		Alain Ravaud, MD, PhD	Ph:  33-5-5679-5808
			Email: alain.ravaud@chu-bordeaux.fr
	Clermont-Ferrand
	Centre Jean Perrin
		Jean Olivier	Ph:  33-73-278-080
	Chu-Hopital Gabriel Montpied
		Laurent Guy, MD	Ph:  33-0473-750-750
			Email: lguy@chu-clermontferrand.fr
	Grenoble
	CHU de Grenoble - Hopital Michallon
		Frederic Garban, MD, PhD	Ph:  33-4-7676-5028
	Lille
	Centre Hospital Universitaire Hop Huriez
		J.P. Jouet, MD	Ph:  33 3 20 444197
			Email: jpjouet@chru-lille.fr
	Centre Oscar Lambret
		Armelle Caty, MD	Ph:  33-32-029-5959
			Email: acaty@o-lambret.fr
	Limoges
		Nicole Tubiana-Mathieu, MD	Ph:  33-5-5505-6123
			Email: oncologie@chu-limoges.fr
	Centre Hospital Regional Universitaire de Limoges
		Dominique Bordessoule, MD, PhD	Ph:  33-5-5505-6642
			Email: bordessoule@unilim.fr
	Lyon
	Centre Leon Berard
		Sylvie Negrier, MD	Ph:  33-4-7878-2751
			Email: negrier@lyon.fnclcc.fr
	Hopital Edouard Herriot - Lyon
		Mauricette Michallet, MD	Ph:  33-472117401
	Marseille
	Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
		Didier Blaise, MD	Ph:  33-4-91-22-37-54
			Email: blaised@marseille.fnclcc.fr
	Montpellier
	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
		Stephane Culine, MD	Ph:  33-4-6761-3755
			Email: stculine@valdorel.fnclcc.fr
	Hopital Lapeyronie-CHU Montpellier
		Eric Legouffe, MD	Ph:  33-4-67-33-80-79
			Email: e-legouffe@chu-montpellier.fr
	Nice
	Centre Antoine Lacassagne
		Antoine Thyss, MD	Ph:  33-04-9203-1538
			Email: antoine.thyss@cal.nice.fnclcc.fr
	Hopital de l'Archet CHU de Nice
		Contact Person	Ph:  33-49-203-9267
	Paris
	Institut Curie Hopital
		Pierre Dorval, MD	Ph:  33-1-44-324-679
			Email: thierry.dorval@curie.net
	Pessac
	Hopital Haut Leveque
		Reza Tabrizi, MD	Ph:  33-57-656-511
	Poitiers
	Hopital Jean Bernard
		Jean-Marc Tourani, MD	Ph:  33-549-444-534
			Email: jm.tourani@chu.poitiers.frs.fr
	Rennes
	Centre Eugene Marquis
		Brigitte Laguerre	Ph:  33-2-9925-3000
	Centre Hospitalier Universitaire de Rennes
		Thiery Lamy, MD, PhD	Ph:  33-2-99-28-42-91
			Email: thierry.lamy@univ-rennes1.fr
	Rouen
	Centre Henri Becquerel
		Nathalie Contentin	Ph:  33-2-3208-2222
	Vandoeuvre-les-Nancy
	Centre Alexis Vautrin
		Lionnel Geoffrois, MD	Ph:  33-3-8359-8400
	Vandoeuvre-Les-Nancy
	Hopitaux de Brabois
		Pierre Bordigoni
	Villejuif
	Institut Gustave Roussy
		Jean-Henri Bourhis, MD, PhD	Ph:  33-1-42-11-4507
			Email: jhb@igr.fr

Registry Information
Official Title		Phase II Trial in Intrafamilial Allogeneic Cell Transplant in Patients with Metastatic Kidney Cancer
Trial Start Date		2002-12-31
Registered in ClinicalTrials.gov		NCT00056095
Date Submitted to PDQ		2003-01-28
Information Last Verified		2006-12-03

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