CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
Antineoplaston therapy (Atengenal + Astugenal)drug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Histologically confirmed childhood brain tumor for which no curative therapy exists
  • ✓Age 6 months to 17 years
  • ✓Measurable tumor by MRI within 2 weeks prior to study entry, at least 5 mm
  • ✓Karnofsky performance status 60–100%
Key exclusion· 6
  • ✕Prior antineoplaston therapy
  • ✕Severe heart disease, history of heart failure, or uncontrolled hypertension
  • ✕Severe lung disease
  • ✕History of renal conditions that contraindicate high dosages of sodium

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

Search/NCT00003458
NCT00003458Phase 2Completed
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Phase II Study of Antineoplastons A10 and AS2-1 in Children With Brain Tumors

Burzynski Research Institute·interventional·Posted Jan 27, 2003·Updated Mar 7, 2022

In Brief

A Phase 2 clinical trial evaluating Antineoplaston therapy (Atengenal + Astugenal) for Childhood Brain Tumors. Completed, enrolled 34 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChildhood Brain Tumors
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
19961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartSep 1, 1996
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 18 yearsPosted 23.4 years ago

Interventions

Antineoplaston therapy (Atengenal + Astugenal)drug

Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).