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Mesothelioma Clinical Trials

Antineoplaston Therapy in Treating Patients With Advanced Mesothelioma

This study is currently recruiting patients.

Sponsored by

Burzynski Research Institute
For more information:National Cancer Institute (NCI)
 
 

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 mesothelioma.

Condition Treatment or Intervention
advanced malignant mesothelioma
recurrent malignant mesothelioma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Procedure: biological response modifier therapy
Procedure: cancer prevention intervention
Procedure: complementary and alternative therapy
Procedure: differentiation therapy

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
Study Design: Treatment

Official Title: Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Stage IV Mesothelioma

Further Study Details: 

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 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

Criteria

DISEASE CHARACTERISTICS:

  • 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


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