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Experimental therapy for deadly brain tumor stalls after single patient

NCT ID NCT02742883

Disease control Sponsor: Burzynski Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This phase 2 study tests two experimental drugs, atengenal and astugenal, in people with diffuse intrinsic pontine glioma (DIPG), a rare and aggressive brain tumor. The trial aimed to enroll up to 100 participants across five age and treatment groups, but only 1 person joined before the study was suspended. The goal was to see if the drugs could shrink tumors or extend survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Antineoplaston therapy (atengenal and astugenal)
What this could lead to
If it works, this could point toward a treatment for DIPG, a rare and aggressive brain tumor in children.
What could go wrong
The trial is very early (phase 2), has only 1 participant, and is currently suspended. Antineoplaston therapy is controversial and not widely accepted.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

1 person

The number who actually took part.

Started

Apr 2016

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 months to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Five cohorts of patients with diffuse, intrinsic pontine glioma will be studied: 1. Patients age 3 months to \< 3 years; 2. Patients age 3-21 years with progressive disease (PD) following radiation therapy (RT) ± chemotherapy and/or other therapies; 3. Patients age 3-21 years with newly diagnosed DIPG who (or whose parents / guardians) have refused RT; 4. Patients age \> 21 years with PD following RT ± chemotherapy and/or other therapies; and 5. Patients age \> 21 years with newly diagnosed DIPG who have refused RT. Exclusion Criteria include: 1. Disseminated disease, multicentric tumors, or leptomeningeal disease; 2. Uncontrolled intercurrent illness; 3. A history of New York Heart Association Class II congestive heart failure or above; 4. Pregnancy.

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Conditions

The condition(s) this trial relates to.

diffuse intrinsic pontine glioma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diffuse intrinsic pontine glioma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Burzynski Clinic

    Houston, Texas, 77055-6330, United States

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