Mesothelioma Related Clinical Trials:
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Mesothelioma


    - General Info     - Purpose     - Eligibility     - Contacts & Locations     - Additional Information

Status: Recruiting
Sponsors and Collaborators: Burzynski Research Institute
Information provided by: National Cancer Institute (NCI)
Government Identifier: NCT00003508

Condition: Malignant Mesothelioma
Intervention: Drug: antineoplaston A10, Drug: antineoplaston AS2-1, Procedure: antineoplastons therapy, Procedure: differentiation therapy

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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.

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Mesothelioma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate based on tumor measurements taken at 12 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival at 1, 2, and 5 years from the start of treatment [ Designated as safety issue: No ]

Estimated Enrollment:   40
Study Start Date:   March 1996
Estimated Primary Completion Date:   December 2011 (Final data collection date for primary outcome measure)

Detailed Description:

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.

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Eligibility:

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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Contacts and Locations:

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003508
Locations
United States, Texas
Burzynski Clinic     Recruiting
      Houston, Texas, United States, 77055-6330
      Contact: Stanislaw R. Burzynski, MD, PhD     713-335-5697     info@burzynskiclinic.com    

Sponsors and Collaborators
Burzynski Research Institute

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

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Additional Information:

Study ID Numbers:   CDR0000066551, BC-MA-2
First Received:   November 1, 1999
Last Updated:   January 10, 2008
ClinicalTrials.gov Identifier:   NCT00003508
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
advanced malignant mesothelioma  
recurrent malignant mesothelioma  

Study placed in the following topic categories:
Mesothelioma
Adenoma
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Mesothelioma
Neoplasms, Mesothelial

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