Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer

February 23, 2021 updated by: UNICANCER

Phase II Trial in Intrafamilial Allogeneic Cell Transplant in Patients With Metastatic Kidney Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49033
        • Centre Hospitalier Regional et Universitaire d'Angers
      • Angers, France, 49100
        • Centre Paul Papin
      • Besancon, France, 25030
        • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
      • Bordeaux, France, 33075
        • Hopital Saint André
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • Clermont-Ferrand, France, 63003
        • CHU-Hopital Gabriel Montpied
      • Grenoble, France, 38043
        • CHU de Grenoble - Hopital Michallon
      • Lille, France, 59037
        • Centre Hospital Universitaire Hop Huriez
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Limoges, France, 87042
        • Centre Hospital Regional Universitaire de Limoges
      • Lyon, France, 69437
        • Hopital Edouard Herriot - Lyon
      • Lyon, France, 69373
        • Centre Leon Berard
      • Marseille, France, 13273
        • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
      • Montpellier, France, 34298
        • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
      • Montpellier, France, 34295
        • Hopital Lapeyronie-CHU Montpellier
      • Nice, France, F-06202
        • Hopital de l'Archet CHU de Nice
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Paris, France, 75248
        • Institut Curie Hopital
      • Pessac, France, 33604
        • Hopital Haut Leveque
      • Poitiers, France, 86021
        • Hopital Jean Bernard
      • Rennes, France, 35033
        • Centre Hospitalier Universitaire de Rennes
      • Rennes, France, 35042
        • Centre Eugène Marquis
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Vandoeuvre-Les-Nancy, France, 54511
        • Hôpitaux de Brabois
      • Vandoeuvre-les-Nancy, France, 54511
        • Centre Alexis Vautrin
      • Villejuif, France, F-94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Allograft (compatible family member)
Drug: cyclophosphamide
Biological: therapeutic allogeneic lymphocytes
Drug: fludarabine phosphate
Procedure: allogeneic bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Drug: cyclosporine
Other: Allograft (compatible non-family member)
Procedure: allogeneic bone marrow transplantation
Procedure: peripheral blood stem cell transplantation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNICANCER

Investigators

  • Study Chair: Didier Blaise, MD, Institut Paoli-Calmettes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2002

Primary Completion (Actual)

February 13, 2008

Study Completion (Actual)

August 17, 2016

Study Registration Dates

First Submitted

March 6, 2003

First Submitted That Met QC Criteria

March 6, 2003

First Posted (Estimate)

March 7, 2003

Study Record Updates

Last Update Posted (Actual)

February 24, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UC-0160/0105
  • FRE-FNCLCC-GETUG-11/0105 (Other Identifier: FNCLCC)
  • EU-20234 (Other Identifier: European union)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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