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Antineoplaston Therapy in Treating Children With Visual Pathway Glioma (VPG)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Burzynski Research Institute
ClinicalTrials.gov Identifier:
NCT00003477
First received: November 1, 1999
Last updated: October 25, 2016
Last verified: October 2016
  Purpose

RATIONALE: Current therapies for children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy, provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy.


Condition Intervention Phase
Visual Pathway Glioma
Drug: Antineoplaston therapy (Atengenal + Astugenal)
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Antineoplastons A10 and AS2-1 Infusions in Children With Visual Pathway Glioma

Resource links provided by NLM:


Further study details as provided by Burzynski Research Institute:

Primary Outcome Measures:
  • Number of Participants With Objective Response [ Time Frame: 12 months ]
    Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks. Stable Disease (SD): <50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions and no Progressive Disease, sustained for at least four weeks. Progressive Disease (PD): >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.


Secondary Outcome Measures:
  • Percentage of Participants Who Survived [ Time Frame: 6 months, 12 months, 24 months, 36 months, 48 months, 60 months ]
    6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival


Enrollment: 12
Study Start Date: June 1996
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antineoplaston therapy
Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Drug: Antineoplaston therapy (Atengenal + Astugenal)
Children with a visual pathway glioma, which is not amenable to standard therapy or has not responded to standard therapy, will receive Antineoplaston therapy (Atengenal + Astugenal).
Other Name: A10 (Atengenal); AS2-1 (Astugenal)

Detailed Description:

OBJECTIVES:

  • To determine the efficacy of Antineoplaston therapy in children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy, as measured by an objective response to therapy (complete response, partial response or stable disease).
  • To determine the safety and tolerance of Antineoplaston therapy in children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy.

OVERVIEW: This is a single arm, open-label study in which children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy, receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) 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 a complete or partial response or with stable disease may continue treatment.

To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

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

  Eligibility

Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed (unless medically contraindicated) visual pathway glioma, which is not amenable to standard therapy or did not respond to standard therapy.
  • Evidence of tumor by MRI scan performed within 2 weeks prior to the study entry
  • 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
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 ClinicalTrials.gov identifier: NCT00003477

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

Additional Information:
Responsible Party: Burzynski Research Institute
ClinicalTrials.gov Identifier: NCT00003477     History of Changes
Other Study ID Numbers: CDR0000066514
BC-BT-23 ( Other Identifier: Burzynski Research Institute, Inc. )
Study First Received: November 1, 1999
Results First Received: August 4, 2016
Last Updated: October 25, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Burzynski Research Institute:
visual pathway glioma not amenable to standard therapy
visual pathway glioma not responding to standard therapy

Additional relevant MeSH terms:
Glioma
Optic Nerve Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Optic Nerve Neoplasms
Cranial Nerve Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Peripheral Nervous System Neoplasms
Cranial Nerve Diseases
Nervous System Diseases
Optic Nerve Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2017