Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-29 @ 4:33 AM
Study NCT ID:
NCT00003512
Status:
WITHDRAWN
Last Update Posted:
2018-02-05
First Post:
1999-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom's Macroglobulinemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008258', 'term': 'Waldenstrom Macroglobulinemia'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'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': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C052091', 'term': 'antineoplaston A10'}, {'id': 'C092038', 'term': 'antineoplaston AS 2-1'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No participants enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '1999-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2000-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-01', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-04-26', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Waldenstrom Macroglobulinemia Recurrent', 'Waldenstrom Macroglobulinemia Refractory'], 'conditions': ['Waldenstrom Macroglobulinemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.burzynskiresearch.com', 'label': 'Burzynski Research Institute'}, {'url': 'http://www.burzynskiclinic.com', 'label': 'Burzynski Clinic'}]}, 'descriptionModule': {'briefSummary': "Current therapies for Recurrent or Refractory Waldenstrom's Macroglobulinemia provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Recurrent or Refractory Waldenstrom's Macroglobulinemia.\n\nPURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Recurrent or Refractory Waldenstrom's Macroglobulinemia.", 'detailedDescription': "Recurrent or Refractory Waldenstrom's Macroglobulinemia patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.\n\nOBJECTIVES:\n\n* To determine the efficacy of Antineoplaston therapy in patients with Recurrent or Refractory Waldenstrom's Macroglobulinemia, as measured by an objective response to therapy (complete response, partial response or stable disease).\n* To determine the safety and tolerance of Antineoplaston therapy in patients with Recurrent or Refractory Waldenstrom's Macroglobulinemia.\n* To determine objective response, tumor size is measured utilizing physical examination, radiologic studies, and bone marrow biopsies as necessary, performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed recurrent or progressive Waldenstrom's macroglobulinemia that is unlikely to respond to existing therapy, including surgery, radiotherapy, and chemotherapy\n\n * Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan\n * Must have received and failed at least one standard first-line therapy (e.g., corticosteroid/alkylator combination)\n* Biochemical evidence of Waldenstrom's macroglobulinemia\n\n * Abnormal proteins in serum and urine\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* Karnofsky 60-100%\n\nLife expectancy:\n\n* At least 2 months\n\nHematopoietic:\n\n* WBC at least 2000/mm3\n* Platelet count at least 50,000/mm3\n\nHepatic:\n\n* No hepatic insufficiency\n* Bilirubin no greater than 2.5 mg/dL\n* SGOT and SGPT no greater than 5 times upper limit of normal\n\nRenal:\n\n* No renal insufficiency\n* Creatinine no greater than 2.5 mg/dL\n* No history of renal conditions that contraindicate high dosages of sodium\n\nCardiovascular:\n\n* No uncontrolled hypertension\n* No history of congestive heart failure\n* No history of other cardiovascular conditions that contraindicate high dosages of sodium\n\nPulmonary:\n\n* No serious lung disease, such as chronic obstructive pulmonary disease\n\nOther:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception during and for 4 weeks after study\n* No active infection\n* No non-malignant systemic disease\n* Not a high medical or psychiatric risk\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 4 weeks since prior immunotherapy\n* No concurrent immunomodulating agent\n\nChemotherapy:\n\n* See Disease Characteristics\n* At least 4 weeks (6 weeks since nitrosoureas) since prior chemotherapy\n* No concurrent antineoplastic agents\n\nEndocrine therapy:\n\n* See Disease Characteristics\n* Concurrent corticosteroids allowed\n\nRadiotherapy:\n\n* See Disease Characteristics\n* At least 8 weeks since prior radiotherapy\n\nSurgery:\n\n* See Disease Characteristics\n* Recovered from prior surgery\n\nOther:\n\n* No prior antineoplastons\n* Prior cytodifferentiating agents allowed"}, 'identificationModule': {'nctId': 'NCT00003512', 'briefTitle': "Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom's Macroglobulinemia", 'organization': {'class': 'OTHER', 'fullName': 'Burzynski Research Institute'}, 'officialTitle': 'Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Macroglobulinemia of Waldenstrom', 'orgStudyIdInfo': {'id': 'CDR0000066555'}, 'secondaryIdInfos': [{'id': 'BC-MW-2', 'type': 'OTHER', 'domain': 'Burzynski Research Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Antineoplaston therapy', 'description': 'Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.', 'interventionNames': ['Drug: Antineoplaston therapy (Atengenal + Astugenal)']}], 'interventions': [{'name': 'Antineoplaston therapy (Atengenal + Astugenal)', 'type': 'DRUG', 'otherNames': ['A10 (Atengenal); AS2-1 (Astugenal)'], 'description': "Patients With Recurrent or Refractory Waldenstrom's Macroglobulinemia will receive Antineoplaston therapy (Atengenal + Astugenal).\n\nThe daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.", 'armGroupLabels': ['Antineoplaston therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77055-6330', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Burzynski Clinic', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Stanislaw R. Burzynski, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Burzynski Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Burzynski Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}