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| ID | Type | Description | Link |
|---|---|---|---|
| FRE-FNCLCC-GETUG-11/0105 | Other Identifier | FNCLCC | |
| EU-20234 | Other Identifier | European union |
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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allograft (compatible family member) | Experimental |
| |
| Allograft (compatible non-family member) | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic allogeneic lymphocytes | Biological |
| ||
| cyclophosphamide |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate at 18 months | ||
| Objective rate of response | ||
| Post-transplant immunological reactions and recuperation | ||
| Antitumoral activity |
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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:
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
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Didier Blaise, MD | Institut Paoli-Calmettes | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Regional et Universitaire d'Angers | Angers | 49033 | France | |||
| Centre Paul Papin |
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| Drug |
|
| cyclosporine | Drug |
|
| fludarabine phosphate | Drug |
|
| allogeneic bone marrow transplantation | Procedure |
|
| peripheral blood stem cell transplantation | Procedure |
|
| Angers |
| 49100 |
| France |
| Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz | Besançon | 25030 | France |
| Hopital Saint Andre | Bordeaux | 33075 | France |
| Chu-Hopital Gabriel Montpied | Clermont-Ferrand | 63003 | France |
| Centre Jean Perrin | Clermont-Ferrand | 63011 | France |
| CHU de Grenoble - Hopital Michallon | Grenoble | 38043 | France |
| Centre Oscar Lambret | Lille | 59020 | France |
| Centre Hospital Universitaire Hop Huriez | Lille | 59037 | France |
| Centre Hospital Regional Universitaire de Limoges | Limoges | 87042 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| Hopital Edouard Herriot - Lyon | Lyon | 69437 | France |
| Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes | Marseille | 13273 | France |
| Hopital Lapeyronie-CHU Montpellier | Montpellier | 34295 | France |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Montpellier | 34298 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Hopital de l'Archet CHU de Nice | Nice | F-06202 | France |
| Institut Curie Hopital | Paris | 75248 | France |
| Hopital Haut Leveque | Pessac | 33604 | France |
| Hopital Jean Bernard | Poitiers | 86021 | France |
| Centre Hospitalier Universitaire de Rennes | Rennes | 35033 | France |
| Centre Eugene Marquis | Rennes | 35042 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Centre Alexis Vautrin | Vandœuvre-lès-Nancy | 54511 | France |
| Hopitaux de Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| Institut Gustave Roussy | Villejuif | F-94805 | France |
| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D016572 | Cyclosporine |
| C042382 | fludarabine phosphate |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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