Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2025-12-25 @ 10:59 PM
Study NCT ID:
NCT00002567
Status:
COMPLETED
Last Update Posted:
2013-06-27
First Post:
1999-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High-Dose Chemotherapy and Radiation Therapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Acute Leukemia in Remission
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D004915', 'term': 'Leukemia, Erythroblastic, Acute'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D015473', 'term': 'Leukemia, Promyelocytic, Acute'}, {'id': 'D015479', 'term': 'Leukemia, Myelomonocytic, Acute'}, {'id': 'D007948', 'term': 'Leukemia, Monocytic, Acute'}, {'id': 'D007947', 'term': 'Leukemia, Megakaryoblastic, Acute'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D036102', 'term': 'Peripheral Blood Stem Cell Transplantation'}], 'ancestors': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'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': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1994-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2000-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-25', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-05-21', 'lastUpdatePostDateStruct': {'date': '2013-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-11', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['adult acute myeloid leukemia in remission', 'adult acute lymphoblastic leukemia in remission', 'adult acute erythroid leukemia (M6)', 'adult acute myeloblastic leukemia without maturation (M1)', 'adult acute myeloblastic leukemia with maturation (M2)', 'adult acute promyelocytic leukemia (M3)', 'adult acute myelomonocytic leukemia (M4)', 'adult acute monoblastic leukemia (M5a)', 'adult acute megakaryoblastic leukemia (M7)', 'adult acute monocytic leukemia (M5b)', 'bone marrow ablation', 'adult acute minimally differentiated myeloid leukemia (M0)'], 'conditions': ['Bone Marrow Ablation', 'Leukemia']}, '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 transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.\n\nPURPOSE: Phase II trial to study the effectiveness of high-dose radiation therapy and etoposide followed by peripheral stem cell transplantation in treating patients with acute leukemia.', 'detailedDescription': 'OBJECTIVES: I. Evaluate the efficacy of myeloablative total-body irradiation and etoposide followed by autologous peripheral blood stem cell (PBSC) transplantation in prolonging the disease-free survival of patients with acute leukemia. II. Investigate the ability of growth factor-primed PBSC to provide hematopoietic reconstitution following myeloablative therapy.\n\nOUTLINE: Patients are treated on Regimen A, then Regimen B. Regimen A: Stem Cell Mobilization. Granulocyte Colony Stimulating Factor (Amgen), G-CSF, NSC-614629. Regimen B: Radiotherapy and Myeloablative Chemotherapy with Hematopoietic Rescue. Total-Body Irradiation, TBI (high-energy electrons used for lung boost); and Etoposide, VP-16, NSC-141540; with Peripheral Blood Stem Cells, PBSC; G-CSF.\n\nPROJECTED ACCRUAL: Up to 45 patients will be studied over approximately 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Previously diagnosed acute leukemia in one of the following categories: Acute myelogenous leukemia (any subtype) in first or subsequent remission Ph+ acute lymphoblastic leukemia (ALL) in first or greater remission Ph- ALL in second or subsequent remission Cellular marrow with no morphologic evidence of residual leukemia within approximately 2 weeks of cryopreservation Negative CSF cytology required of ALL patients Allogeneic marrow transplant considered for patients under age 55 with a healthy HLA-identical family member available\n\nPATIENT CHARACTERISTICS: Age: Over 16 to 65 Performance status: Not specified Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dl Renal: Creatinine no greater than 1.5 mg/dl OR Creatinine clearance at least 60 ml/min Cardiovascular: LVEF at least 50% by MUGA or normal on echocardiogram Pulmonary: DLCO at least 50% of predicted Other: HIV seronegative No uncontrolled infection Negative pregnancy test required of fertile women\n\nPRIOR CONCURRENT THERAPY: See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00002567', 'briefTitle': 'High-Dose Chemotherapy and Radiation Therapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Acute Leukemia in Remission', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'PHASE II STUDY EVALUATING AUTOLOGOUS PERIPHERAL BLOOD PROGENITOR CELL TRANSPLANTATION FOR ACUTE LEUKEMIAS', 'orgStudyIdInfo': {'id': '93-161'}, 'secondaryIdInfos': [{'id': 'CDR0000063595', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'NCI-H94-0460'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'filgrastim', 'type': 'BIOLOGICAL'}, {'name': 'etoposide', 'type': 'DRUG'}, {'name': 'peripheral blood stem cell transplantation', 'type': 'PROCEDURE'}, {'name': 'low-LET electron therapy', 'type': 'RADIATION'}, {'name': 'low-LET photon therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Peter Maslak, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}