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

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.

Study Type: Interventional

Study Design: Treatment

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.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.

Primary:

• Response rate based on tumor measurements taken at 12 weeks No

Secondary:

• Survival at 1, 2, and 5 years from the start of treatment No

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

PATIENT CHARACTERISTICS:

Age:

• 1 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 2 months

Hematopoietic:

• WBC at least 2,000/mm^3
• Platelet count at least 50,000/mm^3

Hepatic:

• Bilirubin no greater than 2.5 mg/dL
• SGOT and SGPT no greater than 5 times upper limit of normal
• Hepatic function adequate

Renal:

• Creatinine no greater than 2.5 mg/dL
• No renal insufficiency
• No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

• No uncontrolled hypertension
• No history of congestive heart failure
• No cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

• No serious lung disease (e.g., chronic obstructive pulmonary disease)

Other:

• 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:

Biologic therapy:

• At least 4 weeks since prior immunotherapy and recovered
• No concurrent immunomodulatory agents

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

Endocrine therapy:

• Concurrent corticosteroids allowed

Radiotherapy:

• At least 8 weeks since prior radiotherapy (or less if multiple tumors) and recovered

Surgery:

• Recovered from prior surgery

Other:

• Prior cytodifferentiating agents allowed
• No prior antineoplastons
• No other concurrent antineoplastic agents

Lead Sponsor: Burzynski Research Institute

Burzynski Clinic

Houston Texas 77055-6330 United States

Overall Clinical Trial Officials and Contacts

Stanislaw R. Burzynski, MD, PhD Study Chair Burzynski Research Institute  

Information obtained from ClinicalTrials.gov on July 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00003508

Study ID Number: CDR0000066551

ClinicalTrials.gov Identifier: NCT00003508

Health Authority: Unspecified

Clinical trial summary from the National Cancer Institute's PDQ® database