Suspended

Phase II Study of Antineoplastons A10 and AS2-1 in Children With High Grade Glioma

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What is being tested

Antineoplaston therapy (Atengenal + Astugenal)

Drug
Who is being recruted

Neoplasms+6

+ Neoplasms by Histologic Type

+ Neoplasms, Germ Cell and Embryonal

From 6 Months to 18 Years
+23 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 1994
See protocol details

Summary

Principal SponsorBurzynski Research Institute
Last updated: March 21, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1994

Actual date on which the first participant was enrolled.

OBJECTIVES: To determine the efficacy of Antineoplaston therapy in children with recurrent/progressive high grade gliomas, 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 recurrent/progressive high grade gliomas. OVERVIEW: This is a single arm, open-label study in which children with recurrent/progressive high grade gliomas 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 for this study.

NCT00003535
Principal SponsorBurzynski Research Institute
Last updated: March 21, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

9 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 Months to 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroectodermal TumorsNeoplasms, NeuroepithelialAstrocytomaGlioma

Criteria

14 inclusion criteria required to participate
At least 4 weeks elapsed since last dose of chemotherapy (6 weeks for nitrosoureas)
Male or female patients
At least 8 weeks elapsed since last dose of radiation
Performance status: Karnofsky 60-100%
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9 exclusion criteria prevent from participating
Lung disease
Pregnant or nursing
Concurrent antineoplastic or immunomodulatory agents
Severe heart disease
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Burzynski Clinic

Houston, United StatesOpen Burzynski Clinic in Google Maps
SuspendedOne Study Center