Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:29 PM
Study NCT ID:
NCT00301093
Status:
COMPLETED
Last Update Posted:
2020-10-28
First Post:
2006-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vaccine Therapy and Imatinib Mesylate in Treating Patients With Chronic Phase 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': 'D000068877', 'term': 'Imatinib Mesylate'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-26', 'studyFirstSubmitDate': '2006-03-08', 'studyFirstSubmitQcDate': '2006-03-08', 'lastUpdatePostDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Toxicity', 'timeFrame': '3 years', 'description': 'To assess the safety and toxicity of GM-K462 vaccination in CP CML patients who have acheived a complete hematologic response to imatinib.'}], 'secondaryOutcomes': [{'measure': 'Disease Response', 'timeFrame': '3 years', 'description': 'To assess disease response after GM-K562 vaccination by serial BCR-ABL Q-PCR measurements'}, {'measure': 'Tumor immunity', 'timeFrame': '3 years', 'description': 'To characterize the development of tumor immunity in response to vaccination with GM-K562 cells'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chronic phase chronic myelogenous leukemia', 'Philadelphia chromosome positive chronic myelogenous leukemia'], 'conditions': ['Leukemia']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Vaccines made from gene-modified cancer cells may help the body build an effective immune response to kill cancer cells. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving vaccine therapy together with imatinib mesylate may be an effective treatment for chronic myelogenous leukemia.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy when given together with imatinib mesylate in treating patients with chronic phase chronic myelogenous leukemia.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the maximum tolerated dose of GM-K562 cell vaccine when administered with imatinib mesylate in patients with persistent chronic phase chronic myelogenous leukemia in first hematologic response.\n* Determine the safety and toxic effects of GM-K562 cell vaccination in these patients.\n\nSecondary\n\n* Determine the disease response by serial BCR-ABL quantitative polymerase chain reaction measurements in patients treated with this regimen.\n* Determine the development of tumor immunity in patients treated with this regimen.\n\nOUTLINE: This is a dose-escalation study of GM-K562.\n\nPatients continue to receive oral imatinib mesylate at the same stable dose as before study entry. Patients receive GM-K562 subcutaneously on days 1, 8, 15, 29, 43, 57, 85, 113, and 141 in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 10 patients receive escalating doses of GM-K562 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 10 patients experience dose-limiting toxicity.\n\nAfter completion of study treatment, patients are followed periodically for 20 years.\n\nPROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of chronic myelogenous leukemia\n\n * Chronic phase disease\n * Philadelphia chromosome positive disease\n* Disease in first complete hematologic response, defined by all of the following:\n\n * Complete normalization of peripheral blood counts with WBC \\< 10,000/mm\\^3\n * Platelet count \\< 450,000/mm\\^3\n * No immature cells (e.g., myelocytes, metamyelocytes, or blasts) in the peripheral blood\n* Persistent molecular evidence of disease\n\n * Detectable BCR-ABL transcript by quantitative polymerase chain reaction\n * Less than 2 log reduction in peripheral blood or bone marrow BCR-ABL transcripts levels compared to a standardized baseline\n* Must have received imatinib mesylate for \\> 1 year of which the last 3 months were at stable dose ≥ 300 mg/day\n\nPATIENT CHARACTERISTICS:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* Negative pregnancy test\n* No known HIV\n* ALT or AST ≤ 3 times upper limit of normal\n* Oxygen saturation ≥ 93% at room air\n* No history of recent acute myocardial infarction\n* No history of unstable angina\n* No pulmonary decomposition requiring hospitalization within the past 3 months\n* No concurrent and/or uncontrolled psychiatric or medical condition that would preclude study compliance\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No prior allogeneic stem cell transplantation\n* At least 2 months since other prior experimental therapy\n* At least 6 months since prior participation in another vaccine study\n* No concurrent systemic immunosuppressive medication'}, 'identificationModule': {'nctId': 'NCT00301093', 'briefTitle': 'Vaccine Therapy and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia', 'nctIdAliases': ['NCT00215475'], 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'Vaccination for CML Patients With Persistent Disease on Imatinib Mesylate', 'orgStudyIdInfo': {'id': '04-126'}, 'secondaryIdInfos': [{'id': 'R21CA115043', 'link': 'https://reporter.nih.gov/quickSearch/R21CA115043', 'type': 'NIH'}, {'id': 'P30CA006516', 'link': 'https://reporter.nih.gov/quickSearch/P30CA006516', 'type': 'NIH'}, {'id': 'CDR0000456445', 'type': 'REGISTRY', 'domain': 'NCI PDQ'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'GM-K562 cell vaccine', 'type': 'BIOLOGICAL', 'description': 'Once weekly for 3 vaccination, then every other week for 3 vaccinations, and then every month for 3 vaccinations until the participant has received a total of 9 vaccinations'}, {'name': 'imatinib mesylate', 'type': 'DRUG', 'description': 'Participants will continue on current dose'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Martha Wadleigh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Martha Wadleigh, M.D.', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}