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| Sponsored by: |
Federation Nationale des Centres de Lutte Contre le Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00056095 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Biological: therapeutic allogeneic lymphocytes Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Active Control |
| Official Title: | Phase II Trial in Intrafamilial Allogeneic Cell Transplant in Patients With Metastatic Kidney Cancer |
| Estimated Enrollment: | 170 |
| Study Start Date: | December 2002 |
OBJECTIVES:
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.
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Localized metastases allowed provided the following are true:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| France | |
| Centre Alexis Vautrin | Recruiting |
| Vandoeuvre-les-Nancy, France, 54511 | |
| Contact: Lionnel Geoffrois, MD 33-3-8359-8400 | |
| Centre Antoine Lacassagne | Recruiting |
| Nice, France, 06189 | |
| Contact: Antoine Thyss, MD 33-04-9203-1538 antoine.thyss@cal.nice.fnclcc.fr | |
| Centre Eugene Marquis | Recruiting |
| Rennes, France, 35042 | |
| Contact: Brigitte Laguerre 33-2-9925-3000 | |
| Centre Henri Becquerel | Recruiting |
| Rouen, France, 76038 | |
| Contact: Nathalie Contentin 33-2-3208-2222 | |
| Centre Hospital Regional Universitaire de Limoges | Recruiting |
| Limoges, France, 87042 | |
| Contact: Dominique Bordessoule, MD, PhD 33-5-5505-6642 bordessoule@unilim.fr | |
| Centre Hospital Universitaire Hop Huriez | Recruiting |
| Lille, France, 59037 | |
| Contact: J.P. Jouet, MD 33 3 20 444197 jpjouet@chru-lille.fr | |
| Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz | Recruiting |
| Besancon, France, 25030 | |
| Contact: Contact Person 33-81-668-240 | |
| Centre Hospitalier Regional et Universitaire d'Angers | Recruiting |
| Angers, France, 49033 | |
| Contact: Norbert Ifrah, MD 33-2-41-35-4472 | |
| Centre Hospitalier Universitaire de Rennes | Recruiting |
| Rennes, France, 35033 | |
| Contact: Thiery Lamy, MD, PhD 33-2-99-28-42-91 thierry.lamy@univ-rennes1.fr | |
| Centre Jean Perrin | Recruiting |
| Clermont-Ferrand, France, 63011 | |
| Contact: Jean Olivier 33-73-278-080 | |
| Centre Leon Berard | Recruiting |
| Lyon, France, 69373 | |
| Contact: Sylvie Negrier, MD 33-4-7878-2751 negrier@lyon.fnclcc.fr | |
| Centre Oscar Lambret | Recruiting |
| Lille, France, 59020 | |
| Contact: Armelle Caty, MD 33-32-029-5959 acaty@o-lambret.fr | |
| Centre Paul Papin | Recruiting |
| Angers, France, 49100 | |
| Contact: Remy Delva 33-49-800-918-507 | |
| Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes | Recruiting |
| Marseille, France, 13273 | |
| Contact: Didier Blaise, MD 33-4-91-22-37-54 blaised@marseille.fnclcc.fr | |
| CHU de Grenoble - Hopital Michallon | Recruiting |
| Grenoble, France, 38043 | |
| Contact: Frederic Garban, MD, PhD 33-4-7676-5028 | |
| Chu-Hopital Gabriel Montpied | Recruiting |
| Clermont-Ferrand, France, 63003 | |
| Contact: Laurent Guy, MD 33-0473-750-750 lguy@chu-clermontferrand.fr | |
| Hopital de l'Archet CHU de Nice | Recruiting |
| Nice, France, F-06202 | |
| Contact: Contact Person 33-49-203-9267 | |
| Hopital Edouard Herriot - Lyon | Recruiting |
| Lyon, France, 69437 | |
| Contact: Mauricette Michallet, MD 33-472117401 | |
| Hopital Haut Leveque | Recruiting |
| Pessac, France, 33604 | |
| Contact: Reza Tabrizi, MD 33-57-656-511 | |
| Hopital Jean Bernard | Recruiting |
| Poitiers, France, 86021 | |
| Contact: Jean-Marc Tourani, MD 33-549-444-534 jm.tourani@chu.poitiers.frs.fr | |
| Hopital Lapeyronie-CHU Montpellier | Recruiting |
| Montpellier, France, 34295 | |
| Contact: Eric Legouffe, MD 33-4-67-33-80-79 e-legouffe@chu-montpellier.fr | |
| Hopital Saint Andre | Recruiting |
| Bordeaux, France, 33075 | |
| Contact: Alain Ravaud, MD, PhD 33-5-5679-5808 alain.ravaud@chu-bordeaux.fr | |
| Hopitaux de Brabois | Recruiting |
| Vandoeuvre-Les-Nancy, France, 54511 | |
| Contact: Pierre Bordigoni Not Available | |
| Institut Curie Hopital | Recruiting |
| Paris, France, 75248 | |
| Contact: Pierre T. Dorval, MD 33-1-44-324-679 thierry.dorval@curie.net | |
| Institut Gustave Roussy | Recruiting |
| Villejuif, France, F-94805 | |
| Contact: Jean-Henri Bourhis, MD, PhD 33-1-42-11-4507 jhb@igr.fr | |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Recruiting |
| Montpellier, France, 34298 | |
| Contact: Stephane Culine, MD 33-4-6761-3755 stculine@valdorel.fnclcc.fr | |
| Study Chair: | Didier Blaise, MD | Institut Paoli-Calmettes |
More Information
| Study ID Numbers: | CDR0000271936, FRE-FNCLCC-GETUG-11/0105, EU-20234 |
| Study First Received: | March 6, 2003 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00056095 History of Changes |
| Health Authority: | Unspecified |
|
recurrent renal cell cancer stage IV renal cell cancer |
|
Antimetabolites Urinary Tract Neoplasm Cyclosporine Immunologic Factors Urogenital Neoplasms Cyclophosphamide Urologic Neoplasms Cyclosporins Renal Cancer Urologic Diseases Kidney Neoplasms Antifungal Agents Kidney Diseases |
Alkylating Agents Kidney Cancer Fludarabine monophosphate Immunosuppressive Agents Recurrence Carcinoma Carcinoma, Renal Cell Fludarabine Antineoplastic Agents, Alkylating Adenocarcinoma Antirheumatic Agents Neoplasms, Glandular and Epithelial |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Cyclosporine Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Cyclophosphamide Urologic Neoplasms Cyclosporins Neoplasms by Site Urologic Diseases Kidney Neoplasms |
Antifungal Agents Therapeutic Uses Kidney Diseases Dermatologic Agents Alkylating Agents Neoplasms by Histologic Type Enzyme Inhibitors Fludarabine monophosphate Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Myeloablative Agonists Carcinoma, Renal Cell Fludarabine |