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Antineoplaston Therapy in Treating Children With Visual Pathway Glioma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsored by: Burzynski Research Institute
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003477
  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 children with visual pathway glioma.


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 Infusions in Children With Visual Pathway Glioma

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: June 1996
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the antitumor activity of antineoplastons A10 and AS2-1 in children with visual pathway glioma by determining the proportion of patients who experience an objective tumor response.
  • Evaluate the adverse effects of and tolerance to this regimen in these patients.

OUTLINE: This is an open label study.

Patients receive gradually escalating doses of intravenous antineoplastons A10 and AS2-1 6 times per day until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression and unacceptable toxicity. After 12 months, patients with responding or stable disease may continue treatment.

Tumors are measured every 8 weeks during the first 2 years, every 3 months during the third and fourth years, every 6 months during the fifth and sixth years, and yearly thereafter.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed (unless medically contraindicated) visual pathway glioma that is unlikely to respond to existing therapy and for which no curative therapy exists

    • Evidence of tumor by MRI or CT scan
  • Tumor must be at least 5 mm
  • No brain stem tumors

PATIENT CHARACTERISTICS:

Age:

  • 6 months to 17 years

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 2 months

Hematopoietic:

  • WBC at least 2000/mm3
  • Platelet count greater than 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 renal insufficiency
  • No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

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

Pulmonary:

  • No severe lung disease

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

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

Endocrine therapy:

  • Concurrent corticosteroids for cerebral edema allowed (must be on stable dose for at least 1 week prior to study)

Radiotherapy:

  • At least 8 weeks since prior radiotherapy and recovered

Surgery:

  • Not specified

Other:

  • No prior antineoplaston therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003477

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
  More Information

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

Responsible Party: Burzynski Clinic ( Stanislaw R. Burzynski )
Study ID Numbers: CDR0000066514, BC-BT-23
Study First Received: November 1, 1999
Last Updated: December 23, 2008
ClinicalTrials.gov Identifier: NCT00003477  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
untreated childhood visual pathway glioma
recurrent childhood visual pathway glioma

Study placed in the following topic categories:
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Central Nervous System Neoplasms
Recurrence
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

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

ClinicalTrials.gov processed this record on January 14, 2009