Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer

Kidney Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00056095
• Other study ID #: UC-0160/0105
• Secondary ID: FRE-FNCLCC-GETUG
• Status: Completed
• Phase: Phase 2
• Start date: November 4, 2002
• Est. completion date: August 17, 2016

Study information

• Verified date: February 2021
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: August 17, 2016
• Est. primary completion date: February 13, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Biological:
• therapeutic allogeneic lymphocytes

Drug:
• cyclophosphamide

• cyclosporine

• fludarabine phosphate

Procedure:
• allogeneic bone marrow transplantation

• peripheral blood stem cell transplantation

Locations

Country	Name	City	State
France	Centre Hospitalier Regional et Universitaire d'Angers	Angers
France	Centre Paul Papin	Angers
France	Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz	Besancon
France	Hopital Saint Andre	Bordeaux
France	Centre Jean Perrin	Clermont-Ferrand
France	Chu-Hopital Gabriel Montpied	Clermont-Ferrand
France	CHU de Grenoble - Hopital Michallon	Grenoble
France	Centre Hospital Universitaire Hop Huriez	Lille
France	Centre Oscar Lambret	Lille
France	Centre Hospital Regional Universitaire de Limoges	Limoges
France	Centre Leon Berard	Lyon
France	Hopital Edouard Herriot - Lyon	Lyon
France	Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes	Marseille
France	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier
France	Hopital Lapeyronie-CHU Montpellier	Montpellier
France	Centre Antoine Lacassagne	Nice
France	Hopital de l'Archet CHU de Nice	Nice
France	Institut Curie Hopital	Paris
France	Hopital Haut Leveque	Pessac
France	Hopital Jean Bernard	Poitiers
France	Centre Eugene Marquis	Rennes
France	Centre Hospitalier Universitaire de Rennes	Rennes
France	Centre Henri Becquerel	Rouen
France	Centre Alexis Vautrin	Vandoeuvre-les-Nancy
France	Hopitaux de Brabois	Vandoeuvre-Les-Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate at 18 months
Primary	Objective rate of response
Primary	Post-transplant immunological reactions and recuperation
Primary	Antitumoral activity