Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT00003502
Status:
WITHDRAWN
Last Update Posted:
2013-07-10
First Post:
1999-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Antineoplaston Therapy in Treating Patients With Mantle Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and 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'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D000529', 'term': 'Complementary Therapies'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-12', 'lastUpdateSubmitDate': '2013-07-09', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Contiguous Stage II Mantle Cell Lymphoma', 'Noncontiguous Stage II Mantle Cell Lymphoma', 'Stage III Mantle Cell Lymphoma', 'Stage IV Mantle Cell Lymphoma', 'Recurrent Mantle Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.\n\nPURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating patients with stage II, stage III, or stage IV mantle cell lymphoma.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening stage II, III, or IV mantle cell lymphoma.\n* Evaluate the response to, tolerance to, and side effects of this regimen in these patients.\n\nOUTLINE: This is an open-label study.\n\nPatients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 intravenously 6 times daily until the maximum tolerated dose is reached. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nTumors are measured every 8 weeks for 6 months, every 3 months for 2 years, every 6 months for the third and fourth years, and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 20-40 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 stage II, III, or IV mantle cell lymphoma that is not curable by surgery, radiotherapy, and/or chemotherapy\n* Measurable tumor of greater than 2 cm in largest diameter for lymph nodes located in head, neck, axillary, inguinal, and femoral areas (at least 1 cm for other areas)\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 greater than 2000/mm\\^3\n* Platelet count greater than 20,000/mm\\^3\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* 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 hypertension\n* No history of congestive heart failure\n* No history of cardiovascular conditions that contraindicate high dosages of sodium\n\nOther:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception during and for 4 weeks after study participation\n* No serious active infections requiring treatment\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 4 weeks since prior immunotherapy and recovered\n* No concurrent immunomodulatory agent (e.g., interferon or interleukin-2)\n\nChemotherapy:\n\n* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered\n* No concurrent antineoplastic agent\n\nEndocrine therapy:\n\n* At least 4 weeks since prior corticosteroids (e.g., dexamethasone or prednisone)\n* No concurrent dexamethasone, prednisone, or other corticosteroids\n\nRadiotherapy:\n\n* At least 8 weeks since prior radiotherapy and recovered\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* No prior antineoplaston therapy\n* No concurrent antibiotics, antifungals, or antivirals'}, 'identificationModule': {'nctId': 'NCT00003502', 'briefTitle': 'Antineoplaston Therapy in Treating Patients With Mantle Cell Lymphoma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Stage II, III, or IV Mantle Cell Lymphoma', 'orgStudyIdInfo': {'id': 'BC-LY-9'}, 'secondaryIdInfos': [{'id': 'CDR0000066542', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'antineoplaston A10', 'type': 'DRUG'}, {'name': 'antineoplaston AS2-1', 'type': 'DRUG'}, {'name': 'alternative product therapy', 'type': 'PROCEDURE'}, {'name': 'biological therapy', 'type': 'PROCEDURE'}, {'name': 'biologically based therapies', 'type': 'PROCEDURE'}, {'name': 'cancer prevention intervention', 'type': 'PROCEDURE'}, {'name': 'complementary and alternative therapy', 'type': 'PROCEDURE'}, {'name': 'differentiation therapy', 'type': 'PROCEDURE'}]}, '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': 'STUDY_CHAIR', 'affiliation': 'Burzynski Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Burzynski Research Institute', 'class': 'OTHER'}}}}