Who is sponsoring NCT00003458?

NCT00003458 is sponsored by Burzynski Research Institute.

What drugs are being tested in NCT00003458?

Interventions in NCT00003458: Antineoplaston therapy (Atengenal + Astugenal).

What condition does NCT00003458 study?

NCT00003458 studies Childhood Brain Tumors.

Is NCT00003458 still recruiting?

NCT00003458 is currently completed. Last updated 3 March 2022.

Are results published for NCT00003458?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-03-03 · How we verify

NCT00003458

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase II Study of Antineoplastons A10 and AS2-1 in Children With Brain Tumors

Completed Phase 2 Results posted Last updated 3 March 2022

What this trial tests

Phase 2 trial testing Antineoplaston therapy (Atengenal + Astugenal) in Childhood Brain Tumors in 34 participants. Completed in 1 September 2014.

Timeline

1 September 1996

Primary endpoint
1 September 2014

1 September 2014

Quick facts

Lead sponsor	Burzynski Research Institute
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	1 September 1996
Primary completion	1 September 2014
Estimated completion	1 September 2014
Sites	1 location across United States

Drugs / interventions tested

Antineoplaston therapy (Atengenal + Astugenal) — full drug profile →

Conditions studied

Childhood Brain Tumors — all drugs for Childhood Brain Tumors →

Sponsor

Burzynski Research Institute

Who can join

Adults 6 Months to 18, any sex, with Childhood Brain Tumors. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of Participants With Objective Response
Time frame: 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.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Antineoplaston therapy (Atengenal + Astugenal)

Trials testing the same drug.

NCT00003512 — Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom's Macroglobulinemia · Phase 2 · withdrawn
NCT00003498 — Antineoplaston Therapy in Treating Patients With Non-Hodgkin's Lymphoma · Phase 2 · terminated
NCT00003522 — Antineoplaston Therapy in Treating Patients With Cancer of the Small Intestine · Phase 2 · terminated
NCT00003513 — Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Neuroblastoma · Phase 2 · terminated
NCT00003515 — Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors · Phase 2 · terminated

Other Burzynski Research Institute trials

Trials by the same sponsor.

NCT00003512 — Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom's Macroglobulinemia · Phase 2 · withdrawn
NCT00003498 — Antineoplaston Therapy in Treating Patients With Non-Hodgkin's Lymphoma · Phase 2 · terminated
NCT00003522 — Antineoplaston Therapy in Treating Patients With Cancer of the Small Intestine · Phase 2 · terminated
NCT00003513 — Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Neuroblastoma · Phase 2 · terminated
NCT00003515 — Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors · Phase 2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00003458 (US National Library of Medicine, public domain)
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: 3 March 2022

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/NCT00003458.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing