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Antineoplaston Therapy in Treating Patients With Primary Malignant Brain Tumors

Study Purpose

RATIONALE: Current therapies for adults with primary malignant brain tumors that have not responded to standard therapy provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with primary malignant brain tumors that have not responded to standard therapy. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with primary malignant brain tumors that have not responded to standard therapy.

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 18 Years - 99 Years
Gender All
More Inclusion & Exclusion Criteria

DISEASE CHARACTERISTICS:

  • - Histologically or cytologically confirmed incurable adult primary malignant brain tumor.
  • - Evidence of progressive or recurrent tumor by MRI scan performed within 2 weeks prior to study entry.
  • - Must have received and failed standard therapy.
  • - Tumor must be at least 5 mm.
  • - No brain stem tumors.
PATIENT CHARACTERISTICS: Age:
  • - 18 and over.
Performance status:
  • - Karnofsky 60-100% Life expectancy: - At least 2 months.
Hematopoietic:
  • - Hematological function normal.
  • - WBC at least 2000/mm^3.
  • - Platelet count at least 50,000/mm^3.
Hepatic:
  • - No liver failure.
  • - No evidence of hepatic insufficiency.
  • - Bilirubin no greater than 2.5 mg/dL.
  • - SGOT/SGPT no greater than 5 times upper limit of normal.
Renal:
  • - No evidence of renal insufficiency.
  • - Creatinine no greater than 2.5 mg/dL.
  • - No history of renal conditions that contraindicate high dosages of sodium.
Cardiovascular:
  • - No uncontrolled hypertension.
  • - No history of congestive heart failure.
  • - No chronic heart failure.
  • - No other cardiovascular conditions that contraindicate high dosages of sodium.
Pulmonary:
  • - No serious lung disease, such as severe chronic obstructive pulmonary disease.
Other:
  • - Not pregnant or nursing.
  • - Fertile patients must use effective contraception during and for 4 weeks after study participation.
  • - No medical or psychiatric illness that would preclude study treatment.
  • - No active infection.
PRIOR CONCURRENT THERAPY: Biologic therapy:
  • - At least 4 weeks since prior immunotherapy.
  • - No concurrent immunomodulating agents.
Chemotherapy:
  • - At least 4 weeks since prior chemotherapy, except in patients with disease progression during initial therapy.
  • - At least 6 weeks since prior nitrosoureas, except in patients with disease progression during initial therapy.
  • - No concurrent antineoplastic agents.
Endocrine therapy:
  • - Corticosteroids allowed.
Radiotherapy:
  • - See Disease Characteristics.
  • - At least 8 weeks since prior radiotherapy, except in patients with disease progression during initial therapy.
Surgery:
  • - At least 4 weeks since prior surgery, except in patients with disease progression during initial therapy.
Other:
  • - Recovered from prior therapy.
- Cytodifferentiating agents allowed

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.

NCT00003475
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.

Malignant Brain Tumors
Study Website: View Trial Website
Additional Details

OBJECTIVES:

  • - To determine the efficacy of Antineoplaston therapy in patients with primary malignant brain tumors that 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 patients with a primary malignant brain tumor.
OVERVIEW: This is a single arm, open-label study in which adults with malignant brain tumors that 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: 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)

Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

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