CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
Antineoplaston therapy (Atengenal + Astugenal)drug
Likely dose
Not stated in record
Key inclusion· 6
  • Histologically confirmed low-grade astrocytoma
  • Persistent or progressive tumor after standard therapy documented by MRI within 2 weeks prior to study entry
  • Tumor at least 5 mm in size
  • Age 6 months to 17 years
Key exclusion· 8
  • Prior Antineoplaston therapy
  • Severe heart disease, uncontrolled hypertension, history of congestive heart failure, or cardiovascular conditions that contraindicate high-dose sodium
  • Severe lung disease
  • History of renal conditions that contraindicate high-dose sodium

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

Search/NCT00003468
NCT00003468Phase 2Completed

Phase II Study of Antineoplastons A10 and AS2-1 in Children With Low Grade Astrocytoma

Burzynski Research Institute·interventional·Posted Jan 27, 2003·Updated Nov 21, 2023

In Brief

A Phase 2 clinical trial evaluating Antineoplaston therapy (Atengenal + Astugenal) for Low Grade Astrocytomas. Completed, enrolled 11 participants across 1 site.

Detailed Summary

RATIONALE: Current therapies for children with low grade astrocytomas that 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 low grade astrocytomas that 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 (\> 6 months of age) with low grade astrocytomas that has 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 StartJul 1, 1996
Primary CompletionJul 1, 2004
TodayJul 2, 2026
Enrollment to primary: 8 yearsPosted 23.4 years ago

Interventions

Antineoplaston therapy (Atengenal + Astugenal)drug

Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).