Antineoplaston Therapy in Treating Patients With Meningioma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: July 23, 2008
Last verified: April 2004

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 meningioma that has progressed or recurred after surgery and radiation therapy.

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 Meningioma

Resource links provided by NLM:

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

Estimated Enrollment: 40
Study Start Date: August 1998
Detailed Description:


  • Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with meningioma.
  • Describe response, 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 by intravenous injection 6 times daily until the maximum tolerated dose is reached. Treatment continues for at least 3 months in the absence of disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR.

Tumors are measured every 1-3 months during the first 2 years, every 3-4 months during the third and fourth years, every 4-6 months during the fifth year, and yearly 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 confirmed incurable meningioma that has progressed or recurred following surgical resection and radiotherapy

    • Evidence of tumor by MRI or CT scan



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 2 months


  • Hemoglobin at least 9 g/dL
  • WBC at least 2000/mm3
  • Platelet count at least 50,000/mm3


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


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


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


  • No serious lung disease, such as chronic obstructive pulmonary disease


  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 4 weeks after study
  • No active infection
  • No other serious concurrent disease


Biologic therapy:

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


  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
  • No concurrent antineoplastic agents

Endocrine therapy:

  • Concurrent corticosteroids allowed
  • At least 4 weeks since prior therapy with mifepristone and recovered


  • At least 8 weeks since prior radiotherapy and recovered


  • Recovered from prior surgery


  • Prior cytodifferentiating agent allowed
  • No prior antineoplaston therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00003483

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

Additional Information:
No publications provided Identifier: NCT00003483     History of Changes
Other Study ID Numbers: CDR0000066521, BC-BT-28
Study First Received: November 1, 1999
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor
adult grade III meningioma

Additional relevant MeSH terms:
Central Nervous System Neoplasms
Nervous System Neoplasms
Meningeal Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Nerve Tissue
Neoplasms, Vascular Tissue
Nervous System Diseases processed this record on November 30, 2015