Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT00030303
Status:
COMPLETED
Last Update Posted:
2017-04-28
First Post:
2002-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D015466', 'term': 'Leukemia, Myeloid, Chronic-Phase'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}], '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'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018840', 'term': 'HSP70 Heat-Shock Proteins'}], 'ancestors': [{'id': 'D006360', 'term': 'Heat-Shock Proteins'}, {'id': 'D018832', 'term': 'Molecular Chaperones'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2004-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-26', 'studyFirstSubmitDate': '2002-02-14', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-01', 'type': 'ACTUAL'}}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic phase chronic myelogenous leukemia', 'chronic myelogenous leukemia, BCR-ABL1 positive'], 'conditions': ['Leukemia']}, 'referencesModule': {'references': [{'pmid': '15958631', 'type': 'RESULT', 'citation': 'Li Z, Qiao Y, Liu B, Laska EJ, Chakravarthi P, Kulko JM, Bona RD, Fang M, Hegde U, Moyo V, Tannenbaum SH, Menoret A, Gaffney J, Glynn L, Runowicz CD, Srivastava PK. Combination of imatinib mesylate with autologous leukocyte-derived heat shock protein and chronic myelogenous leukemia. Clin Cancer Res. 2005 Jun 15;11(12):4460-8. doi: 10.1158/1078-0432.CCR-05-0250.'}]}, 'descriptionModule': {'briefSummary': "RATIONALE: Vaccines made from a person's white blood cells may make the body build an immune response to kill cancer cells.\n\nPURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have chronic myelogenous leukemia.", 'detailedDescription': 'OBJECTIVES:\n\n* Determine the feasibility of vaccination with autologous heat shock protein 70 in patients with chronic phase chronic myelogenous leukemia.\n* Determine the toxicity of this vaccination in these patients.\n\nOUTLINE: Patients undergo leukapheresis to obtain peripheral mononuclear cells (PMNCs). Heat shock protein 70 (HSP70) is derived from the autologous PMNCs. Patients receive HSP70 intradermally once weekly for 8 weeks.\n\nPatients are followed for 2 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of chronic phase chronic myelogenous leukemia\n\n * Philadelphia chromosome positive\n* Peripheral blast count no greater than 10%\n* No molecular remission\n* Less than 3 years since initial diagnosis\n* No anticipation of requirement for bone marrow or stem cell transplantation for 6 months\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-1\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Hemoglobin at least 10 g/dL\n* Platelet count at least 20,000/mm\\^3\n\nHepatic:\n\n* Bilirubin less than 2.0 times upper limit of normal (ULN)\n* Transaminase less than 2.0 times ULN\n\nRenal:\n\n* Creatinine less than 2.0 mg/dL\n\nOther:\n\n* Not pregnant\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No significant active infection requiring hospitalization\n* No other serious illness or significant behavioral or psychological problem that would preclude study involvement\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* See Disease Characteristics\n* Prior interferon alfa allowed\n* No concurrent interferon alfa\n\nChemotherapy:\n\n* Prior cytarabine or other cytotoxic agents allowed\n* No concurrent cytarabine or other cytotoxic agents\n* Concurrent hydroxyurea allowed\n\nEndocrine therapy:\n\n* No concurrent corticosteroid therapy\n\nRadiotherapy:\n\n* Not specified\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* No concurrent immunosuppressive medications\n* Concurrent imatinib mesylate allowed'}, 'identificationModule': {'nctId': 'NCT00030303', 'briefTitle': 'Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'UConn Health'}, 'officialTitle': 'A Feasibility And Toxicity Study Of Vaccination With HSP70 For The Treatment Of Chronic Myelogenous Leukemia In Chronic Phase', 'orgStudyIdInfo': {'id': 'UCHC-01117'}, 'secondaryIdInfos': [{'id': 'CDR0000069127', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'UCHC-7659'}, {'id': 'NCI-V01-1685'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'vaccine', 'description': 'recombinant 70-kD heat-shock protein', 'interventionNames': ['Biological: recombinant 70-kD heat-shock protein']}], 'interventions': [{'name': 'recombinant 70-kD heat-shock protein', 'type': 'BIOLOGICAL', 'armGroupLabels': ['vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06030-1601', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'University of Connecticut Health Center', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}], 'overallOfficials': [{'name': 'Zihai Li, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'UConn Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UConn Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}