Trial · NCT00003460
Antineoplaston Therapy in Treating Children With Primitive Neuroectodermal Tumors
NCT00003460, Phase 2, Completed, Burzynski Research Institute; results first posted 2016-11-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Antineoplaston Therapy in Treating Children With Primitive Neuroectodermal Tumors. Trials, record NCT00003460. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00003460
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Antineoplaston Therapy in Treating Children With Primitive Neuroectodermal Tumors
- NCT number
- NCT00003460
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- Burzynski Research Institute
- Conditions
- Childhood CNS Primitive Neuroectodermal Tumor
- Interventions
- Antineoplaston therapy (Atengenal + Astugenal)
- First posted
- 2003-01-27
- Last updated
- 2017-08-24
- Results first posted
- 2016-11-10
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Objective Response | 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. |
| Secondary | Percentage of Participants Who Survived | 6 months, 12 months, 24 months, 36 months, 48 months, 60 months | 6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Objective Response | 12 months | Participants | NUMBER | |
| SECONDARY | Percentage of Participants Who Survived | 6 months, 12 months, 24 months, 36 months, 48 months, 60 months | All study subjects receiving any Antineoplaston therapy | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Objective Response | Antineoplaston Therapy | Complete Response | 3 | Participants | |
| Number of Participants With Objective Response | Antineoplaston Therapy | Partial Response | 1 | Participants | |
| Number of Participants With Objective Response | Antineoplaston Therapy | Stable Disease | 1 | Participants | |
| Number of Participants With Objective Response | Antineoplaston Therapy | Progressive Disease | 7 | Participants | |
| Percentage of Participants Who Survived | Antineoplaston Therapy | 6 months overall survival | 61.5 | Percentage of participants | |
| Percentage of Participants Who Survived | Antineoplaston Therapy | 12 months overall survival | 61.5 | Percentage of participants | |
| Percentage of Participants Who Survived | Antineoplaston Therapy | 24 months overall survival | 53.8 | Percentage of participants | |
| Percentage of Participants Who Survived | Antineoplaston Therapy | 36 months overall survival | 46.2 | Percentage of participants | |
| Percentage of Participants Who Survived | Antineoplaston Therapy | 48 months overall survival | 38.5 | Percentage of participants | |
| Percentage of Participants Who Survived | Antineoplaston Therapy | 60 months overall survival | 38.5 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Antineoplaston Therapy | 13 | |
| Overall Study | COMPLETED | Antineoplaston Therapy | 12 | |
| Overall Study | NOT COMPLETED | Antineoplaston Therapy | 1 |
Source ClinicalTrials.gov
Adverse events81
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Allergic reaction/hypersensitivity (including drug fever) | General disorders | Antineoplaston Therapy | 2 | 13 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Antineoplaston Therapy | 5 | 13 | |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | Antineoplaston Therapy | 1 | 13 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Antineoplaston Therapy | 1 | 13 | |
| other | Platelets | Blood and lymphatic system disorders | Antineoplaston Therapy | 2 | 13 | |
| other | Supraventricular and nodal arrhythmia: Sinus tachycardia | Cardiac disorders | Antineoplaston Therapy | 1 | 13 | |
| other | Central venous catheter infection | Infections and infestations | Antineoplaston Therapy | 2 | 13 | |
| other | Non-functional central venous catheter | General disorders | Antineoplaston Therapy | 2 | 13 | |
| other | Central venous catheter: Other | General disorders | Antineoplaston Therapy | 2 | 13 | |
| other | Central venous catheter: Thrombosis/embolism | General disorders | Antineoplaston Therapy | 1 | 13 |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Antineoplaston Therapy | ||
| Total, other adverse events | Antineoplaston Therapy | 13 | 13 |
| Total, serious adverse events | Antineoplaston Therapy | 10 | 13 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00003460
GET https://conductscience.org/api/trials/v1/NCT00003460/events?page=2