CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
Antineoplaston therapy (Atengenal + Astugenal)drug
Likely dose
Not stated in record
Key inclusion· 7
  • Histologically confirmed incurable primitive neuroectodermal tumor
  • Evidence of progressive or recurrent tumor on MRI within 2 weeks prior to entry
  • Must have received and failed prior standard therapy
  • Tumor at least 5 mm in size
Key exclusion· 8
  • Uncontrolled hypertension
  • Severe heart disease or history of congestive heart failure
  • History of renal conditions that contraindicate high sodium dosages
  • History of cardiovascular conditions that contraindicate high sodium dosages

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

Search/NCT00003460
NCT00003460Phase 2Completed

Phase II Study of Antineoplastons A10 and AS2-1 In Children With Primitive Neuroectodermal Tumors

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 Childhood CNS Primitive Neuroectodermal Tumor. Completed, enrolled 13 participants across 1 site.

Detailed Summary

RATIONALE: Current therapies for children with primitive neuroectodermal tumors that have not responded to standard therapy provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with primitive neuroectodermal tumors 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 primitive neuroectodermal tumors 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 StartApr 1, 1996
Primary CompletionFeb 1, 2005
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 23.4 years ago

Interventions

Antineoplaston therapy (Atengenal + Astugenal)drug

Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).