Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2026-01-01 @ 7:50 AM
Study NCT ID:
NCT00056095
Status:
COMPLETED
Last Update Posted:
2021-02-24
First Post:
2003-03-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'C042382', 'term': 'fludarabine phosphate'}, {'id': 'D036102', 'term': 'Peripheral Blood Stem Cell Transplantation'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D018380', 'term': 'Hematopoietic Stem Cell Transplantation'}, {'id': 'D033581', 'term': 'Stem Cell Transplantation'}, {'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2016-08-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-23', 'studyFirstSubmitDate': '2003-03-06', 'studyFirstSubmitQcDate': '2003-03-06', 'lastUpdatePostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival rate at 18 months'}, {'measure': 'Objective rate of response'}, {'measure': 'Post-transplant immunological reactions and recuperation'}, {'measure': 'Antitumoral activity'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['recurrent renal cell cancer', 'stage IV renal cell cancer'], 'conditions': ['Kidney Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: This phase II trial is studying how well allogeneic stem cell transplant works in treating patients with metastatic kidney cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the 18-month survival rate of patients with metastatic renal cell carcinoma treated with allogeneic stem cell transplantation.\n* Determine the objective rate of response of patients treated with this regimen.\n* Determine post-transplant immunological reactions and recuperation of patients treated with this regimen.\n* Determine the antitumoral activity of this regimen in these patients.\n\nOUTLINE: 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.\n\n* 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.\n* Group II: Patients without a compatible family donor receive treatment (immunotherapy, vaccination therapy, or chemotherapy) at the discretion of the treating physician.\n\nPatients are followed every 3 months for 5 years.\n\nPROJECTED 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed metastatic renal cell carcinoma\n* No sarcomatoid, pure papillary, or Bellini renal cell cancer\n* Measurable and/or evaluable disease\n* Disease progression after at least 1 immunotherapy regimen for metastatic disease\n* Localized metastases allowed provided the following are true:\n\n * At least 3 months since prior treatment for metastases\n * Not considered likely to influence outcome of transplantation\n* No brain metastases unless treated surgically or radiologically and MRI normal\n* Sufficiently healthy, HLA-compatible family member must be available as donor for patients undergoing stem cell transplantation\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 to 65\n\nPerformance status\n\n* ECOG 0-1\n\nLife expectancy\n\n* More than 6 months\n\nHematopoietic\n\n* Platelet count at least 100,000/mm\\^3\n\nHepatic\n\n* Transaminases less than 1.5 times upper limit of normal (ULN)\\*\n* Bilirubin less than 1.5 times ULN\\* NOTE: \\*Unless due to Gilbert's disease\n\nRenal\n\n* No renal insufficiency\n* Calcium less than 10.4 mg/dL\n* Creatinine clearance greater than 50 mL/min\n\nCardiovascular\n\n* Ejection fraction greater than 50%\n\nPulmonary\n\n* No DLCO that would preclude fludarabine or busulfan therapy\n\nOther\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No physical obstacle to receiving study treatment\n* No known autoimmune disease\n* No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix\n* No uncontrolled bacterial, viral, or fungal infection\n* No prior or concurrent psychiatric disease\n* HIV negative\n* HTLV1 negative\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* See Disease Characteristics\n\nChemotherapy\n\n* No tolerance to fludarabine and busulfan\n\nEndocrine therapy\n\n* No concurrent corticosteroids\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified"}, 'identificationModule': {'nctId': 'NCT00056095', 'briefTitle': 'Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer', 'organization': {'class': 'OTHER', 'fullName': 'UNICANCER'}, 'officialTitle': 'Phase II Trial in Intrafamilial Allogeneic Cell Transplant in Patients With Metastatic Kidney Cancer', 'orgStudyIdInfo': {'id': 'UC-0160/0105'}, 'secondaryIdInfos': [{'id': 'FRE-FNCLCC-GETUG-11/0105', 'type': 'OTHER', 'domain': 'FNCLCC'}, {'id': 'EU-20234', 'type': 'OTHER', 'domain': 'European union'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Allograft (compatible family member)', 'interventionNames': ['Biological: therapeutic allogeneic lymphocytes', 'Drug: cyclophosphamide', 'Drug: cyclosporine', 'Drug: fludarabine phosphate', 'Procedure: allogeneic bone marrow transplantation', 'Procedure: peripheral blood stem cell transplantation']}, {'type': 'OTHER', 'label': 'Allograft (compatible non-family member)', 'interventionNames': ['Procedure: allogeneic bone marrow transplantation', 'Procedure: peripheral blood stem cell transplantation']}], 'interventions': [{'name': 'therapeutic allogeneic lymphocytes', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Allograft (compatible family member)']}, {'name': 'cyclophosphamide', 'type': 'DRUG', 'armGroupLabels': ['Allograft (compatible family member)']}, {'name': 'cyclosporine', 'type': 'DRUG', 'armGroupLabels': ['Allograft (compatible family member)']}, {'name': 'fludarabine phosphate', 'type': 'DRUG', 'armGroupLabels': ['Allograft (compatible family member)']}, {'name': 'allogeneic bone marrow transplantation', 'type': 'PROCEDURE', 'armGroupLabels': ['Allograft (compatible family member)', 'Allograft (compatible non-family member)']}, {'name': 'peripheral blood stem cell transplantation', 'type': 'PROCEDURE', 'armGroupLabels': ['Allograft (compatible family member)', 'Allograft (compatible non-family member)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49033', 'city': 'Angers', 'country': 'France', 'facility': "Centre Hospitalier Regional et Universitaire d'Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '49100', 'city': 'Angers', 'country': 'France', 'facility': 'Centre Paul Papin', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33075', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Hopital Saint Andre', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Chu-Hopital Gabriel Montpied', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '63011', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Centre Jean Perrin', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU de Grenoble - Hopital Michallon', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Hospital Universitaire Hop Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Centre Hospital Regional Universitaire de Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Leon Berard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69437', 'city': 'Lyon', 'country': 'France', 'facility': 'Hopital Edouard Herriot - Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13273', 'city': 'Marseille', 'country': 'France', 'facility': 'Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Hopital Lapeyronie-CHU Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': "Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '06189', 'city': 'Nice', 'country': 'France', 'facility': 'Centre Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': 'F-06202', 'city': 'Nice', 'country': 'France', 'facility': "Hopital de l'Archet CHU de Nice", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75248', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Curie Hopital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33604', 'city': 'Pessac', 'country': 'France', 'facility': 'Hopital Haut Leveque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'Hopital Jean Bernard', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '35042', 'city': 'Rennes', 'country': 'France', 'facility': 'Centre Eugene Marquis', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '76038', 'city': 'Rouen', 'country': 'France', 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Centre Alexis Vautrin', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Hopitaux de Brabois', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': 'F-94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Didier Blaise, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institut Paoli-Calmettes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNICANCER', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}