CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Antineoplaston therapy (Atengenal + Astugenal)drug
Likely dose
Not stated in record
Key inclusion· 8
  • Histologically confirmed visual pathway glioma not amenable to standard therapy or unresponsive to standard therapy
  • Evidence of tumor by MRI within 2 weeks prior to study entry
  • Tumor must be at least 5 mm in size
  • Age 6 months to 17 years
Key exclusion· 7
  • Brain stem tumors
  • Severe heart disease, uncontrolled hypertension, history of congestive heart failure, or cardiovascular conditions contraindicated by high sodium dosages
  • Severe lung disease
  • Renal insufficiency or history of renal conditions contraindicated by high sodium dosages

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

Search/NCT00003477
NCT00003477Phase 2Completed

Phase II Study of Antineoplastons A10 and AS2-1 Infusions in Children With Visual Pathway Glioma

Burzynski Research Institute·interventional·Posted Jan 27, 2003·Updated Aug 24, 2017

In Brief

A Phase 2 clinical trial evaluating Antineoplaston therapy (Atengenal + Astugenal) for Visual Pathway Glioma. Completed, enrolled 12 participants across 1 site.

Detailed Summary

RATIONALE: Current therapies for children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy, provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy.

Study Details

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

Timeline

Phase 2CompletedFinished
19961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartJun 1, 1996
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 11.9 yearsPosted 23.4 years ago

Interventions

Antineoplaston therapy (Atengenal + Astugenal)drug

Children with a visual pathway glioma, which is not amenable to standard therapy or has not responded to standard therapy, will receive Antineoplaston therapy (Atengenal + Astugenal).