SuspendedPhase 2

A Study of Atengenal and Astugenal in Diffuse, Intrinsic Pontine Glioma (DIPG)

Stopped: Clinical Hold

United States1 participantsStarted 2016-04-13

Plain-language summary

Current therapies for diffuse, intrinsic pontine glioma (DIPG) provide very limited benefit to the patient. The rationale for the use of Antineoplaston therapy in this protocol study derives from experience with subjects from prior Phase 2 studies and Compassionate Exemption patients treated with Antineoplaston therapy at the Burzynski Clinic. This study is designed to analyze the efficacy and safety of Antineoplaston therapy in five separate DIPG patient cohorts, which are defined by age and prior therapy. This is a two stage study with 20 patients in each cohort being enrolled in the first stage and an additional 20 patients being enrolled in the second stage, if pre-determined efficacy endpoints in the first stage are realized.

Who can participate

Age range3 Months – 99 Years

SexALL

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Inclusion criteria

✓. Patients age 3 months to \< 3 years;
✓. Patients age 3-21 years with progressive disease (PD) following radiation therapy (RT) ± chemotherapy and/or other therapies;
✓. Patients age 3-21 years with newly diagnosed DIPG who (or whose parents / guardians) have refused RT;
✓. Patients age \> 21 years with PD following RT ± chemotherapy and/or other therapies; and
✓. Patients age \> 21 years with newly diagnosed DIPG who have refused RT.

Exclusion criteria

✕. Disseminated disease, multicentric tumors, or leptomeningeal disease;
✕. Uncontrolled intercurrent illness;
✕. A history of New York Heart Association Class II congestive heart failure or above;
✕. Pregnancy.

What they're measuring

Efficacy Measured by Objective Response Rate

Timeframe: 104 weeks

Trial details

NCT IDNCT02742883

SponsorBurzynski Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03

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