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Antineoplaston Therapy in Treating Patients With Meningioma
This study is ongoing, but not recruiting participants.
Sponsored by: Burzynski Research Institute
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003483
  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 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 II

MedlinePlus related topics: Cancer
Drug Information available for: Antineoplaston A10 Antineoplaston AS 2-1
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Meningioma

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

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

OBJECTIVES:

  • 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.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed incurable meningioma that has progressed or recurred following surgical resection and radiotherapy

    • Evidence of tumor by MRI or CT scan

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 2 months

Hematopoietic:

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

Hepatic:

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

Renal:

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

Cardiovascular:

  • 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

Pulmonary:

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

Other:

  • 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

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
  • No concurrent antineoplastic agents

Endocrine therapy:

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

Radiotherapy:

  • At least 8 weeks since prior radiotherapy and recovered

Surgery:

  • Recovered from prior surgery

Other:

  • Prior cytodifferentiating agent allowed
  • No prior antineoplaston therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003483

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

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000066521, BC-BT-28
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00003483  
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Brain Neoplasms
Meningeal Neoplasms
Meningioma
Central Nervous System Neoplasms
Recurrence
Nervous System Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Nervous System Diseases
Neoplasms, Nerve Tissue
Neoplasms, Vascular Tissue

ClinicalTrials.gov processed this record on January 14, 2009