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Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer

Primary Purpose

Kidney Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
therapeutic allogeneic lymphocytes
cyclophosphamide
cyclosporine
fludarabine phosphate
allogeneic bone marrow transplantation
peripheral blood stem cell transplantation
Sponsored by
UNICANCER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, stage IV renal cell cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Regional et Universitaire d'Angers
  • Centre Paul Papin
  • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
  • Hopital Saint Andre
  • Chu-Hopital Gabriel Montpied
  • Centre Jean Perrin
  • CHU de Grenoble - Hopital Michallon
  • Centre Oscar Lambret
  • Centre Hospital Universitaire Hop Huriez
  • Centre Hospital Regional Universitaire de Limoges
  • Centre Leon Berard
  • Hopital Edouard Herriot - Lyon
  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
  • Hopital Lapeyronie-CHU Montpellier
  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
  • Centre Antoine Lacassagne
  • Hopital de l'Archet CHU de Nice
  • Institut Curie Hopital
  • Hopital Haut Leveque
  • Hopital Jean Bernard
  • Centre Hospitalier Universitaire de Rennes
  • Centre Eugene Marquis
  • Centre Henri Becquerel
  • Centre Alexis Vautrin
  • Hopitaux de Brabois
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Allograft (compatible family member)

Allograft (compatible non-family member)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 6, 2003
Last Updated
February 23, 2021
Sponsor
UNICANCER
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1. Study Identification

Unique Protocol Identification Number
NCT00056095
Brief Title
Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer
Official Title
Phase II Trial in Intrafamilial Allogeneic Cell Transplant in Patients With Metastatic Kidney Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 4, 2002 (Actual)
Primary Completion Date
February 13, 2008 (Actual)
Study Completion Date
August 17, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
recurrent renal cell cancer, stage IV renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Allograft (compatible family member)
Arm Type
Experimental
Arm Title
Allograft (compatible non-family member)
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
therapeutic allogeneic lymphocytes
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
cyclosporine
Intervention Type
Drug
Intervention Name(s)
fludarabine phosphate
Intervention Type
Procedure
Intervention Name(s)
allogeneic bone marrow transplantation
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Primary Outcome Measure Information:
Title
Survival rate at 18 months
Title
Objective rate of response
Title
Post-transplant immunological reactions and recuperation
Title
Antitumoral activity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier Blaise, MD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hospitalier Regional et Universitaire d'Angers
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Centre Paul Papin
City
Angers
ZIP/Postal Code
49100
Country
France
Facility Name
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Hopital Saint Andre
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Chu-Hopital Gabriel Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
CHU de Grenoble - Hopital Michallon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Hospital Universitaire Hop Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Hospital Regional Universitaire de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Hopital Edouard Herriot - Lyon
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Hopital Lapeyronie-CHU Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Hopital de l'Archet CHU de Nice
City
Nice
ZIP/Postal Code
F-06202
Country
France
Facility Name
Institut Curie Hopital
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Hopital Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Hopital Jean Bernard
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Centre Hospitalier Universitaire de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Hopitaux de Brabois
City
Vandoeuvre-Les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France

12. IPD Sharing Statement

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Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer

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