CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Antineoplaston therapy (Atengenal + Astugenal)drug
Likely dose
Antineoplaston A10 and AS2-1 (Atengenal + Astugenal) divided into six infusions at 4-hourly intervals dailyAI-extracted
Key inclusion· 6
  • Histologically or cytologically confirmed Glioblastoma Multiforme
  • Measurable tumor by MRI scan performed within two weeks prior to study entry, with tumor at least 5 mm
  • Subtotal resection or biopsy only (not gross total resection)
  • Age 18 years and over
Key exclusion· 8
  • Brain stem tumor
  • Prior chemotherapy
  • Prior radiotherapy
  • Prior immunotherapy

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

Search/NCT00003456
NCT00003456Phase 2Completed

Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Glioblastoma Multiforme

Burzynski Research Institute·interventional·Posted Jan 27, 2003·Updated Mar 22, 2018

In Brief

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

Detailed Summary

RATIONALE: Current therapies for Glioblastoma Multiforme 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 tumors. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults (≥ 18 years of age) with newly diagnosed Glioblastoma Multiforme.

Study Details

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

Timeline

Phase 2CompletedFinished
199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartMar 14, 1995
Primary CompletionDec 7, 2004
TodayJul 2, 2026
Enrollment to primary: 9.7 yearsPosted 23.4 years ago

Interventions

Antineoplaston therapy (Atengenal + Astugenal)drug

Adults with a newly diagnosed Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.