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Antineoplaston Therapy in Treating Children With Primary Malignant Brain Tumors
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: NCT00003476
  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 primary malignant brain tumors.


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

MedlinePlus related topics: Brain Cancer Cancer Childhood Brain Tumors
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 Children With Primary Malignant Brain Tumors

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

Primary Outcome Measures:
  • Response rate based on 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: March 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 primary malignant brain tumors by determining the proportion of patients who experience an objective tumor response.
  • Evaluate the adverse effects of and tolerance to this regimen in these children.

OUTLINE: This is an open-label study.

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

Tumors are measured every 8 weeks for 2 years, every 3 months for the third and fourth years, every 6 months for the fifth and sixth years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 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 incurable primary malignant brain tumor that has progressed, recurred, or persisted after initial therapy

    • Must have failed prior standard therapy
  • No brain stem glioma
  • Evidence of tumor by MRI or CT scan

PATIENT CHARACTERISTICS:

Age:

  • 6 months to 17 years

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 2 months

Hematopoietic:

  • WBC at least 1,500/mm^3
  • Platelet count greater than 50,000/mm^3

Hepatic:

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

Renal:

  • Creatinine no greater than 2.5 mg/dL

Cardiovascular:

  • No severe heart disease
  • No uncontrolled hypertension

Pulmonary:

  • No severe lung disease

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 4 weeks after study participation
  • 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 (6 weeks for nitrosoureas) and recovered
  • No concurrent antineoplastic agents

Endocrine therapy:

  • Recovered from prior endocrine therapy
  • Concurrent corticosteroids for cerebral edema allowed

Radiotherapy:

  • At least 8 weeks since prior radiotherapy (unless clear radiological evidence of progression) and recovered

Surgery:

  • At least 4 weeks since prior surgery (unless clear radiological evidence of progression) and recovered

Other:

  • No prior antineoplaston therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003476

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: CDR0000066513, BC-BT-22
Study First Received: November 1, 1999
Last Updated: December 23, 2008
ClinicalTrials.gov Identifier: NCT00003476  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
childhood low-grade cerebral astrocytoma
childhood craniopharyngioma
childhood central nervous system germ cell tumor
childhood high-grade cerebral astrocytoma
childhood oligodendroglioma
childhood choroid plexus tumor
childhood grade I meningioma
childhood grade II meningioma
childhood grade III meningioma
recurrent childhood cerebral astrocytoma
recurrent childhood medulloblastoma
recurrent childhood visual pathway and hypothalamic glioma
recurrent childhood ependymoma
recurrent childhood pineoblastoma

Study placed in the following topic categories:
Choroid Plexus Neoplasms
Astrocytoma
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Ependymoma
Recurrence
Brain Neoplasms
Medulloblastoma
Craniopharyngioma
Oligodendroglioma
Meningioma
Glioma
Choroid Plexus neoplasms
Nervous System Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009