Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT00003505
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WITHDRAWN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 Primary Central Nervous System Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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{'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-10', 'lastUpdateSubmitDate': '2013-07-09', 'studyFirstSubmitDate':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': ['Primary Central Nervous System 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 primary central nervous system lymphoma.', 'detailedDescription': 'OBJECTIVES:\n\n* Assess the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening primary central nervous system lymphoma.\n* Describe 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 intravenous antineoplaston A10 and antineoplaston AS2-1 6 times per day until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with responding or stable disease may continue treatment.\n\nTumors are measured every 2 months for 6 months, every 3 months for 2 years, every 6 months for years 3 and 4, and then annually for years 5 and 6.\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 confirmed stage I-IV primary central nervous system lymphoma for which no curative therapy exists\n* Measurable tumor by MRI or CT scan\n* Tumor must be greater than 2 cm in largest diameter\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 2,000/mm\\^3\n* Platelet count greater than 50,000/mm\\^3\n\nHepatic:\n\n* Bilirubin no greater than 2.5 mg/dL\n* SGOT and SGPT no greater than 5 times upper limit of normal\n* No hepatic insufficiency\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 cardiac insufficiency\n* No hypertension\n* No history of congestive heart failure\n* No history of other 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 at least 4 weeks after study participation\n* No serious infection requiring antibiotics, antifungals, or antivirals\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 4 weeks since prior immunotherapy and recovered\n* No concurrent immunomodulatory agents (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* Concurrent corticosteroids allowed\n* Must be on stable dose for at least 4 weeks prior to study entry\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 antineoplastons'}, 'identificationModule': {'nctId': 'NCT00003505', 'briefTitle': 'Antineoplaston Therapy in Treating Patients With Primary Central Nervous System Lymphoma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Primary Central Nervous System Lymphoma', 'orgStudyIdInfo': {'id': 'BC-LY-12'}, 'secondaryIdInfos': [{'id': 'CDR0000066545', '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'}}}}