RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may
inhibit 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 Mesothelioma
Recurrent Malignant Mesothelioma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Procedure: alternative product therapy
Procedure: biological therapy
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: complementary and alternative therapy
Procedure: differentiation therapy
MedlinePlus related topics: Cancer; Cancer Alternative Therapies; Mesothelioma
Genetics Home Reference related topics: Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Stage IV Mesothelioma
Further study details as provided by National Cancer Institute (NCI):
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.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.
Ages Eligible for Study:
1 Year and above,
Genders Eligible for Study:
Bilirubin no greater than 2.5 mg/dL
SGOT and SGPT no greater than 5 times upper limit of normal
Hepatic function adequate
No uncontrolled hypertension
No history of congestive heart failure
No cardiovascular conditions that contraindicate high dosages of sodium
Not pregnant or nursing
Fertile patients must use effective contraception during and for 4 weeks after study participation
Not at high medical or psychiatric risk
No nonmalignant systemic disease
No active infection
PRIOR CONCURRENT THERAPY:
Please refer to this study by ClinicalTrials.gov identifier
Burzynski Clinic, Houston,
United States; Recruiting
Stanislaw R. Burzynski, MD, PhD, Study Chair, Burzynski Research Institute