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Antineoplaston Therapy

Antineoplaston Therapy

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Published by jamesyu

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Published by: jamesyu on Aug 16, 2007
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esothelioma Articles - Antineoplaston Therapy in Treating Patients Wi...http://www.mirg.org/mesothelioma-articles/pdf/antineoplaston-therapy.html1 of 45/1/2007 1:52 PM
Mesothelioma Articles
Antineoplaston Therapy in Treating Patients With Advanced Mesothelioma
This study is currently recruiting patients.
Verified by National Cancer Institute (NCI) September 2006
Sponsored by:Burzynski Research InstituteInformation provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons mayinhibit the growth of cancer cells.PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating patients with advanced mesothelioma.
Advanced Malignant MesotheliomaRecurrent Malignant MesotheliomaDrug: antineoplaston A10Drug: antineoplaston AS2-1Procedure: alternative product therapyProcedure: biological therapyProcedure: biologically based therapiesProcedure: cancer prevention interventionProcedure: complementary and alternative therapyProcedure: differentiation therapyPhase IIMedlinePlus related topics: Cancer; Cancer Alternative Therapies; MesotheliomaGenetics Home Reference related topics: CancerStudy Type: InterventionalStudy Design: TreatmentOfficial Title: Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Stage IV MesotheliomaFurther study details as provided by National Cancer Institute (NCI):OBJECTIVES:Provide treatment with antineoplastons A10 and AS2-1 to patients with stage IV mesothelioma.Describe the response to, tolerance to, and side effects of this regimen in these patients.OUTLINE: Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 IV six times per day untilthe maximum dose is reached.Treatment continues for at least 3 months in the absence of disease progression or unacceptable toxicity. After 3 months, patientswith stable or responding disease may continue treatment. Patients achieving complete response (CR) continue treatment for atleast 8 months beyond CR.
esothelioma Articles - Antineoplaston Therapy in Treating Patients Wi...http://www.mirg.org/mesothelioma-articles/pdf/antineoplaston-therapy.html2 of 45/1/2007 1:52 PM
Patients are followed every 2 months for 1 year and then every 3 months for the second year.PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.
Ages Eligible for Study: 1 Year and above, Genders Eligible for Study: BothCriteriaDISEASE CHARACTERISTICS:Histologically confirmed stage IV mesothelioma that is unlikely to respond to existing therapy and for which no curativetherapy existsEvidence of disease by CT scan or MRIPATIENT CHARACTERISTICS:Age:1 and overPerformance status:Karnofsky 60-100%Life expectancy:At least 2 monthsHematopoietic:WBC at least 2,000/mm^3Platelet count at least 50,000/mm^3Hepatic:Bilirubin no greater than 2.5 mg/dLSGOT and SGPT no greater than 5 times upper limit of normalHepatic function adequateRenal:Creatinine no greater than 2.5 mg/dLNo renal insufficiencyNo history of renal conditions that contraindicate high dosages of sodiumCardiovascular:No uncontrolled hypertensionNo history of congestive heart failureNo cardiovascular conditions that contraindicate high dosages of sodiumPulmonary:
esothelioma Articles - Antineoplaston Therapy in Treating Patients Wi...http://www.mirg.org/mesothelioma-articles/pdf/antineoplaston-therapy.html3 of 45/1/2007 1:52 PM
No serious lung disease (e.g., chronic obstructive pulmonary disease)Other:Not pregnant or nursingFertile patients must use effective contraception during and for 4 weeks after study participationNot at high medical or psychiatric riskNo nonmalignant systemic diseaseNo active infectionPRIOR CONCURRENT THERAPY:Biologic therapy:At least 4 weeks since prior immunotherapy and recoveredNo concurrent immunomodulatory agentsChemotherapy:At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recoveredEndocrine therapy:Concurrent corticosteroids allowedRadiotherapy:At least 8 weeks since prior radiotherapy (or less if multiple tumors) and recoveredSurgery:Recovered from prior surgeryOther:Prior cytodifferentiating agents allowedNo prior antineoplastonsNo other concurrent antineoplastic agents
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00003508
Burzynski Clinic, Houston, Texas, 77055-6330, United States; RecruitingStanislaw R. Burzynski, MD, PhD 713-335-5697info@burzynskiclinic.com Study chairs or principal investigatorsStanislaw R. Burzynski, MD, PhD, Study Chair, Burzynski Research Institute

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