CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Antineoplaston therapy (Atengenal + Astugenal)drug
Likely dose
Not stated in record
Key inclusion· 7
  • Histologically or cytologically confirmed incurable adult anaplastic astrocytoma
  • Evidence of progressive or recurrent tumor by MRI within 2 weeks prior to study entry
  • Must have received and failed standard therapy
  • Tumor must be at least 5 mm
Key exclusion· 10
  • Uncontrolled hypertension
  • History of congestive heart failure
  • History of cardiovascular conditions that contraindicate high dosages of sodium
  • History of renal conditions that contraindicate high dosages of sodium

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

Search/NCT00003470
NCT00003470Phase 2Completed

Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Anaplastic Astrocytoma

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 Anaplastic Astrocytoma. Completed, enrolled 27 participants across 1 site.

Detailed Summary

RATIONALE: Current therapies for adults with anaplastic astrocytomas 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 adults with anaplastic 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 adults with anaplastic astrocytomas that 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 StartMar 1, 1996
Primary CompletionDec 1, 2008
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 12.8 yearsPosted 23.4 years ago

Interventions

Antineoplaston therapy (Atengenal + Astugenal)drug

Adults with an anaplastic astrocytoma that has not responded to standard therapy 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.