Antineoplaston Therapy in Treating Adults With Residual/Recurrent/Progressive Glioblastoma Multiforme
CompletedPhase 2Results postedLast updated 22 March 2018
What this trial tests
Phase 2 trial testing Antineoplaston therapy (Atengenal + Astugenal) in Glioblastoma Multiforme of the Brain in 40 participants. Completed in 21 June 2003.
Adults 18 to 99, any sex, with Glioblastoma Multiforme of the Brain. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Objective ResponsePrimary· 12 months
Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), \>=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.
Complete Response
Group
Value
95% CI
Antineoplaston Therapy
1
Partial Response
Group
Value
95% CI
Antineoplaston Therapy
1
Stable Disease
Group
Value
95% CI
Antineoplaston Therapy
5
Progressive Disease
Group
Value
95% CI
Antineoplaston Therapy
19
Percentage of Participants Who SurvivedSecondary· 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Time frame: 7 years, 3 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
RATIONALE: Current therapies for Glioblastoma Multiforme provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of brain tumors.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults (≥ 18 years of age) with residual/recurrent/progressive Glioblastoma Multiforme.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Burzynski Research Institute
Last refreshed: 22 March 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00003474.