Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-27 @ 4:12 PM
Study NCT ID:
NCT00006466
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2000-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Beta Alethine in Treating Patients With Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D008998', 'term': 'Monoclonal Gammopathy of Undetermined Significance'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006942', 'term': 'Hypergammaglobulinemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C090058', 'term': 'alethine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2000-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-09', 'lastUpdateSubmitDate': '2013-12-17', 'studyFirstSubmitDate': '2000-11-06', 'studyFirstSubmitQcDate': '2003-10-07', 'lastUpdatePostDateStruct': {'date': '2013-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-10-08', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['monoclonal gammopathy of undetermined significance', 'isolated plasmacytoma of bone', 'extramedullary plasmacytoma', 'refractory multiple myeloma', 'stage I multiple myeloma', 'stage II multiple myeloma', 'stage III multiple myeloma'], 'conditions': ['Multiple Myeloma and Plasma Cell Neoplasm', 'Precancerous Condition']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Biological therapies such as beta alethine use different ways to stimulate the immune system and stop cancer cells from growing.\n\nPURPOSE: Phase I/II trial to study the effectiveness of beta alethine in treating patients who have myeloma.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the antitumor effects of low-dose beta alethine in patients with myeloma or progressive monoclonal gammopathy of undetermined significance.\n* Determine the effects of this regimen on anemia, performance status, pain, and delayed-type hypersensitivity (immune response) in these patients.\n* Determine the safety of this regimen in these patients.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive beta alethine subcutaneously every 2 weeks for 6 doses. At day 85, patients may receive an additional 12-week course of therapy in the absence of disease progression or unacceptable toxicity. Patients with an apparent complete response receive additional courses.\n\nPatients are followed for 2 weeks.\n\nPROJECTED ACCRUAL: A total of 13-37 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically proven myeloma\n\n * Multiple myeloma\n * Indolent myeloma with slowly progressive bone pathology\n * Smoldering myeloma with no bone pathology but a progressive increase in M-protein\n * Solitary myeloma OR\n* Diagnosis of evolving monoclonal gammopathy of undetermined significance with increasing M-protein or decreasing hemoglobin level\n* Measurable M-protein or Bence Jones protein\n* Indolent disease not requiring therapy allowed\n* No clinical signs or evidence of active brain involvement or leptomeningeal disease\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* Karnofsky 50-100%\n\nLife expectancy:\n\n* At least 4 months\n\nHematopoietic:\n\n* See Disease Characteristics\n* Neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin at least 10 g/dL\n\nHepatic:\n\n* Bilirubin less than 2.0 mg/dL\n* Transaminases no greater than 2.5 times upper limit of normal\n\nRenal:\n\n* Creatinine no greater than 2.0 mg/dL\n* Creatinine clearance at least 60 mL/min\n\nCardiovascular:\n\n* No acute changes on electrocardiogram\n* No uncontrolled angina, heart failure, or arrhythmia\n\nOther:\n\n* Adequate nutritional status (total protein at least 60.0 g/L, albumin at least 35 g/L)\n* HIV negative\n* No AIDS\n* No active bacterial infection (e.g., abscess) or with fistula\n* No history of alcoholism, drug addiction, or psychotic disorders that would preclude study\n* No other nonmalignant disease that would preclude study\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 4 weeks since prior immunotherapy or cytokines\n\nChemotherapy:\n\n* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or high-dose carboplatin)\n\nEndocrine therapy:\n\n* No concurrent corticosteroids\n\nRadiotherapy:\n\n* No prior radiotherapy to greater than 25% of bone marrow\n\nSurgery:\n\n* Recovered from any prior surgery\n* No prior solid organ transplantation\n\nOther:\n\n* No other concurrent investigational agent\n* No concurrent immunosuppressive agents\n* No concurrent anti-inflammatory agents, including aspirin or over-the-counter or prescription nonsteroidal anti-inflammatory drugs'}, 'identificationModule': {'nctId': 'NCT00006466', 'briefTitle': 'Beta Alethine in Treating Patients With Myeloma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase I/II Study to Assess the Safety and Efficacy of Low Doses of Beta LT in Patients With Myeloma', 'orgStudyIdInfo': {'id': 'CDR0000068280'}, 'secondaryIdInfos': [{'id': 'LIFETIME-LTP-99-01'}, {'id': 'LIFETIME-IRB-0300203'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'beta alethine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Clinic', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '20852', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Victory Over Cancer', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'St. Vincents Comprehensive Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Suzin Mayerson, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'LifeTime Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LifeTime Pharmaceuticals', 'class': 'INDUSTRY'}}}}