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← Rhabdoid Tumor

NCT00003469 · STUDY IN CONTEXT

Antineoplaston Therapy in Treating Children With Rhabdoid Tumor of the Central Nervous System

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.

Source null

→

secondary · POSTED

6 months, 12 months, 24 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-rhabdoid-tumor
nct id
NCT00003469
trial label
Antineoplaston Therapy in Treating Children With Rhabdoid Tumor of the Central Nervous System
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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-rhabdoid-tumor
    nct id
    NCT00003469
    outcome key
    om-0000
    source section id
    NCT00003469-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.
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-rhabdoid-tumor
    nct id
    NCT00003469
    outcome key
    om-0001
    source section id
    NCT00003469-om-0001
    source outcome index
    1
    endpoint
    Percentage of Participants Who Survived
    endpoint definition
    6 months, 12 months, 24 months overall survival
    time origin
    6 months, 12 months, 24 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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-rhabdoid-tumor
    nct id
    NCT00003469
    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): Children with a Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal).
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00003469-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-rhabdoid-tumor
    nct id
    NCT00003469
    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): Children with a Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal).
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00003469-om-0001#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-rhabdoid-tumor
    nct id
    NCT00003469
    harm key
    EG000
    source section id
    NCT00003469-ae
    event group key
    EG000
    event group label
    Antineoplaston Therapy
    serious affected
    3
    serious at risk
    4
    other affected
    4
    other at risk
    4
    frequency threshold
    5
    collection period
    7 years, 2 months
    event definition
    Four patients were recruited between February 1996 and October 2010. All study subjects were seen at the Burzynski Clinic in Houston TX
    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