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· 6
  • Histologically confirmed glioblastoma multiforme that has progressed, recurred, or persisted after initial standard therapy (radiotherapy and/or chemotherapy)
  • Measurable disease by MRI or CT scan
  • Tumor at least 5 mm in size
  • Age 18 years or older
Key exclusion· 6
  • Brain stem tumor
  • Uncontrolled hypertension or history of congestive heart failure
  • Serious lung disease such as severe COPD
  • Prior antineoplaston therapy

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

Search/NCT00003474
NCT00003474Phase 2Completed

Phase II Study of Antineoplastons A10 and AS2-1 in Adult 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 the 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 residual/recurrent/progressive Glioblastoma Multiforme.

Study Details

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

Timeline

Phase 2CompletedFinished
19961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartMar 14, 1996
Primary CompletionJun 21, 2003
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 23.4 years ago

Interventions

Antineoplaston therapy (Atengenal + Astugenal)drug

Adults with a residual/recurrent/progressive 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.