Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer

NCT00056095 | Completed Phase 2 DMC

• 3 other identifiers: UC-0160/0105FRE-FNCLCC-GETUG-11/0105EU-20234
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 26

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.

Conditions

Kidney Cancer

Keywords

recurrent renal cell cancer; stage IV renal cell cancer

Outcome Measures

Primary Outcomes (4)

• Survival rate at 18 months

• Objective rate of response

• Post-transplant immunological reactions and recuperation

• Antitumoral activity

Study Arms (2)

Allograft (compatible family member)

EXPERIMENTAL

Biological: therapeutic allogeneic lymphocytes; Drug: cyclophosphamide; Drug: cyclosporine; Drug: fludarabine phosphate; Procedure: allogeneic bone marrow transplantation; Procedure: peripheral blood stem cell transplantation

Allograft (compatible non-family member)

OTHER

Procedure: allogeneic bone marrow transplantation; Procedure: peripheral blood stem cell transplantation

Interventions

therapeutic allogeneic lymphocytes BIOLOGICAL

Allograft (compatible family member)

cyclophosphamide DRUG

Allograft (compatible family member)

cyclosporine DRUG

Allograft (compatible family member)

fludarabine phosphate DRUG

Allograft (compatible family member)

allogeneic bone marrow transplantation PROCEDURE

Allograft (compatible family member); Allograft (compatible non-family member)

peripheral blood stem cell transplantation PROCEDURE

Allograft (compatible family member); Allograft (compatible non-family member)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (26)

Centre Hospitalier Regional et Universitaire d'Angers

Angers, 49033, France

Location

Centre Paul Papin

Angers, 49100, France

Location

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

Besançon, 25030, France

Location

Hopital Saint Andre

Bordeaux, 33075, France

Location

Chu-Hopital Gabriel Montpied

Clermont-Ferrand, 63003, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

CHU de Grenoble - Hopital Michallon

Grenoble, 38043, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Hospital Universitaire Hop Huriez

Lille, 59037, France

Location

Centre Hospital Regional Universitaire de Limoges

Limoges, 87042, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Hopital Edouard Herriot - Lyon

Lyon, 69437, France

Location

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, 13273, France

Location

Hopital Lapeyronie-CHU Montpellier

Montpellier, 34295, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Hopital de l'Archet CHU de Nice

Nice, F-06202, France

Location

Institut Curie Hopital

Paris, 75248, France

Location

Hopital Haut Leveque

Pessac, 33604, France

Location

Hopital Jean Bernard

Poitiers, 86021, France

Location

Centre Hospitalier Universitaire de Rennes

Rennes, 35033, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Hopitaux de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Cyclophosphamide; Cyclosporine; fludarabine phosphate; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Didier Blaise, MD

  Institut Paoli-Calmettes

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2003
• First Posted: March 7, 2003
• Study Start: November 4, 2002
• Primary Completion: February 13, 2008
• Study Completion: August 17, 2016
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

FR (26)