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Antineoplaston Therapy in Treating Patients With Advanced Mesothelioma

This study is currently recruiting patients.
Verified by National Cancer Institute (NCI) September 2006

Sponsored by:

Burzynski Research Institute

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00003508

Purpose

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.

Condition

Intervention

Phase

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

Phase II

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):

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.

Eligibility

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

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00003508


Texas
      Burzynski Clinic, Houston,  Texas,  77055-6330,  United States; Recruiting

      Stanislaw R. Burzynski, MD, PhD  713-335-5697  info@burzynskiclinic.com 


Study chairs or principal investigators

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

  

More Information

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

Study ID Numbers:  CDR0000066551; BC-MA-2
Last Updated:  September 29, 2006
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003508
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-10-12