Clinical Trial for Mesothelioma Patients: Antineoplaston Therapy Program Objectives
Read the program objectives for this current clinical trial being conducted to study the effects of Antineoplaston therapy program for patients who have been diagnosed with mesothelioma. Please note: this information is provided by Weitz & Luxenberg for informational purposes only.
Primary Outcome Measures:
Response rate based on tumor measurements taken at 12 weeks [ Designated as safety issue: No ]
Secondary Outcome Measures:
Survival at 1, 2, and 5 years from the start of treatment [ Designated as safety issue: No ]
Recruitment Information:
Recruitment Status: Recruiting
Enrollment: 40
Study Start Date: March 1996 through December 2011 (Final data collection date for primary outcome measure)
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 until the maximum dose is reached. Treatment continues for at least 3 months in the absence of disease progression or unacceptable toxicity. After 3 months, patients with stable or responding disease may continue treatment. Patients achieving complete response (CR) continue treatment for at least 8 months beyond CR. Patients are followed every 2 months for 1 year and then every 3 months for the second year.
Courtesy of ClinicalTrials.gov.
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Therapy program to treat mesothelioma patients with Antineoplaston