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Antineoplaston Therapy in Treating Children With Brain Tumors

Study Purpose

RATIONALE: Current therapies for childhood brain tumors provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of childhood brain tumors. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (> 6 months of age) with brain tumors.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 6 Months - 18 Years
Gender All
More Inclusion & Exclusion Criteria

DISEASE CHARACTERISTICS:

  • - Histologically confirmed (except if medically contraindicated) childhood brain tumor for which no curative therapy exists.
  • - Measurable tumor by MRI scan performed within two weeks prior to study entry.
  • - Tumor must be at least 5 mm.
PATIENT CHARACTERISTICS: Age:
  • - 6 months to 17 years.
Performance status:
  • - Karnofsky 60-100% Life expectancy: - At least 2 months.
Hematopoietic:
  • - WBC greater than 2000/mm^3.
  • - Platelet count greater than 50,000/mm^3.
Hepatic:
  • - Bilirubin no greater than 2.5 mg/dL.
  • - SGOT and 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 severe heart disease.
  • - No history of heart failure.
  • - No history of other cardiovascular conditions that contraindicate high dosages of sodium.
  • - 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.
  • - No concurrent immunomodulating agents.
Chemotherapy:
  • - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered.
  • - No concurrent antineoplastic agents.
Endocrine therapy:
  • - Concurrent corticosteroids for cerebral edema allowed (must be on stable dose for at least 1 week before study entry) Radiation therapy: - At least 8 weeks since prior radiotherapy and recovered.
Surgery:
  • - Recovered from any prior surgery.
Other: - No prior antineoplaston therapy

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00003458
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Burzynski Research Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Stanislaw R. Burzynski, MD, PhD
Principal Investigator Affiliation Burzynski Research Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Childhood Brain Tumors
Study Website: View Trial Website
Additional Details

OVERVIEW: This is a single arm, open-label study in which children with brain tumors 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. OBJECTIVES:

  • - To determine the efficacy of Antineoplaston therapy in children with a brain tumor, 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 a brain tumor.
  • - 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: A total of 20-40 patients will be accrued to this study.

Arms & Interventions

Arms

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.

Interventions

Drug: - Antineoplaston therapy (Atengenal + Astugenal)

Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Burzynski Clinic, Houston, Texas

Status

Address

Burzynski Clinic

Houston, Texas, 77055-6330

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