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

• Status: Active, not recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Burzynski Research Institute

Criteria

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.