NCT00003457 · STUDY IN CONTEXT

Antineoplaston Therapy in Treating Patients With Brain Tumors

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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; Stable Disease (SD), \< 50% decrease and \< 25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least 8 weeks; Progressive Disease (PD), \>=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions compared to the lowest sum recorded.

Source null

→

secondary · POSTED

6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival

All study subjects receiving any Antineoplaston therapy

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-central-nervous-system-tumors
nct id: NCT00003457
trial label: Antineoplaston Therapy in Treating Patients With Brain Tumors
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 2
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00003457
outcome key
om-0000
source section id
NCT00003457-om-0000
source outcome index
0
endpoint
Number of Participants With Objective Response
endpoint definition
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; Stable Disease (SD), \< 50% decrease and \< 25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least 8 weeks; Progressive Disease (PD), \>=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions compared to the lowest sum recorded.
time origin
12 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00003457
outcome key
om-0001
source section id
NCT00003457-om-0001
source outcome index
1
endpoint
Percentage of Participants Who Survived
endpoint definition
6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival
time origin
6 months, 12 months, 24 months, 36 months, 48 months, 60 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All study subjects receiving any Antineoplaston therapy
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00003457
outcome key
om-0000
arm key
OG000
arm label
Antineoplaston Therapy
regimen
Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).
analyzed count
31
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00003457-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00003457
outcome key
om-0001
arm key
OG000
arm label
Antineoplaston Therapy
regimen
Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00003457-om-0001#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors
nct id
NCT00003457
harm key
EG000
source section id
NCT00003457-ae
event group key
EG000
event group label
Antineoplaston Therapy
serious affected
27
serious at risk
40
other affected
40
other at risk
40
frequency threshold
5
collection period
15 years, 7 months
event definition
Adverse event data was collected through regular patient assessment and regular laboratory testing
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice