Mesothelioma Clinical Trials
For more information:National
Cancer Institute (NCI)
Therapy in Treating Patients With Advanced
This study is currently
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 studies the effectiveness of
antineoplaston therapy in treating patients who have advanced
recurrent malignant mesothelioma
Procedure: biological response modifier
Procedure: cancer prevention
Procedure: complementary and
This is a Phase II test
In Phase II clinical trials, the study drug or treatment
is given to a larger group of people (100-300) to see if it
is effective and to further evaluate its safety.
Study Type: Interventional
Official Title: Phase II Study of
Antineoplastons A10 and AS2-1 in Patients With Stage IV
Further Study Details:
- 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 1 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: Both
- Histologically confirmed stage IV mesothelioma that is
unlikely to respond to existing therapy and for which no
curative therapy exists
- Evidence of disease by CT scan or MRI