CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Antineoplaston therapy (Atengenal + Astugenal)drug
Likely dose
Not stated in record
Key inclusion· 7
  • Histologically confirmed brain stem glioma (except if medically contraindicated) that is unlikely to respond to existing therapy
  • Tumor at least 5 mm in maximum diameter
  • Age 6 months or older
  • Karnofsky performance status 60-100%
Key exclusion· 9
  • Pregnant or nursing
  • Severe heart disease or uncontrolled hypertension
  • History of congestive heart failure
  • Cardiovascular conditions that contraindicate high dosages of sodium

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00003459
NCT00003459Phase 2Completed

Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Brain Stem Glioma

Burzynski Research Institute·interventional·Posted Jan 27, 2003·Updated Mar 14, 2018

In Brief

A Phase 2 clinical trial evaluating Antineoplaston therapy (Atengenal + Astugenal) for Brain Stem Gliomas. Completed, enrolled 40 participants across 1 site.

Detailed Summary

RATIONALE: Current therapies for a brain stem glioma provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of brain stem gliomas. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (\> 6 months of age) and adults with newly-diagnosed or recurrent brain stem gliomas.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
19961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartMar 1, 1996
Primary CompletionSep 1, 2007
TodayJul 2, 2026
Enrollment to primary: 11.5 yearsPosted 23.4 years ago

Interventions

Antineoplaston therapy (Atengenal + Astugenal)drug

Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)