Antineoplaston Therapy in Treating Patients With Residual or Recurrent Anaplastic Astrocytoma

Antineoplaston Therapy in Treating Patients With Residual or Recurrent Anaplastic Astrocytoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).   Recruitment status was  Recruiting

First Received on November 1, 1999.  
Last Updated on June 9, 2009  
History of Changes
Sponsor: Burzynski Research Institute
Information provided by: National Cancer Institute (NCI) Identifier: NCT00003537

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 residual or recurrent anaplastic astrocytoma.

Condition Intervention Phase
Brain and Central Nervous System Tumors Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Anaplastic Astrocytoma

Resource links provided by NLM:

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

Primary Outcome Measures:

  • Response rate assessed by tumor measurements 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: April 1995
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Detailed Description:


  • Determine the objective response rate in patients with anaplastic astrocytoma treated with antineoplastons A10 and AS2-1 after subtotal resection.
  • Assess tolerance to and side effects of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 IV 6 times daily until the maximum tolerated dose is reached. Treatment continues for at least 2 months in the absence of unacceptable toxicity or disease progression. Patients achieving stable disease or partial response may continue treatment. Patients achieving complete response (CR) continue treatment for an additional 8 months after CR.

Tumors are measured at 1 month, every 1-2 months for 2 years, every 3 months for the third year, every 4 months for the fourth year, every 6 months for the fifth year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed anaplastic astrocytoma

    • Tumor subtotally resected or biopsied
  • Radiologic evidence of residual or recurrent tumor by gadolinium-enhanced MRI, CT scan, or positron-emission tomography
  • No brain stem tumors



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • More than 2 months


  • WBC at least 1,500/mm^3
  • Platelet count at least 50,000/mm^3
  • Hemoglobin at least 10 g/dL


  • Bilirubin no greater than 2.5 mg/dL
  • SGOT and SGPT no greater than 5 times upper limit of normal
  • No hepatic failure


  • Creatinine no greater than 2.5 mg/dL
  • No renal failure


  • No prior congestive heart failure
  • No coronary artery disease
  • No myocardial infarction within the past year
  • No angina requiring medication
  • No uncontrolled hypertension


  • No moderate to severe chronic obstructive pulmonary disease


  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 4 weeks after study participation
  • No active infection
  • No other concurrent serious disease
  • No other prior malignancy except carcinoma in situ of the cervix or superficial nonmelanoma skin cancer


Biologic therapy:

  • No prior immunotherapy
  • No concurrent immunomodulating agents


  • No prior myelosuppressive chemotherapy

Endocrine therapy:

  • Concurrent corticosteroids for cerebral edema allowed


  • No prior myelosuppressive radiotherapy
  • No concurrent radiotherapy


  • See Disease Characteristics
  • Recovered from any prior surgery


  • No prior cytodifferentiating agents
  • No prior antineoplaston therapy
  • No other concurrent antineoplastic agents
  Contacts and Locations

Please refer to this study by its identifier: NCT00003537

United States, Texas
Burzynski Clinic Recruiting
Houston, Texas, United States, 77055-6330
Contact: Stanislaw R. Burzynski, MD, PhD     713-335-5697    
Sponsors and Collaborators
Burzynski Research Institute
Study Chair: Stanislaw R. Burzynski, MD, PhD Burzynski Research Institute
  More Information

Additional Information:

No publications provided

Responsible Party: Stanislaw R. Burzynski, Burzynski Clinic Identifier: NCT00003537    
History of Changes
Other Study ID Numbers: CDR0000066585, BC-BT-8
Study First Received: November 1, 1999
Last Updated: June 9, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent adult brain tumor
adult anaplastic astrocytoma

Additional relevant MeSH terms:

Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases processed this record on August 21, 2012

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