Clinical trial · Interventional
Antineoplaston Therapy in Treating Children With Recurrent or Refractory High-Grade Glioma
Phase II Study of Antineoplastons A10 and AS2-1 in Children With High Grade Glioma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
RATIONALE: Current therapies for children with recurrent/progressive high grade gliomas provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with recurrent/progressive high grade gliomas. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (\> 6 months of age) with recurrent/progressive high grade gliomas.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Grade Glioma | High-Grade Glioma, NOS | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antineoplaston therapy (Atengenal + Astugenal) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Antineoplaston therapy
- description
- 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.
- interventionNames
- Drug: Antineoplaston therapy (Atengenal + Astugenal)
Primary outcomes (1)
- measure
- Number of Participants With Objective Response
- timeFrame
- 12 months
- description
- 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 outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma) that is recurrent or progressive or with residual tumor after standard therapy, including radiotherapy * Measurable tumor by MRI scan performed within two weeks prior to study entry * Male or female patients * Children 6 months to 17 years * Performance status: Karnofsky 60-100% * Life expectancy of at least 2 months * WBC greater than 1,500/mm\^3 * Platelet count greater than 50,000/mm\^3 * No evidence of hepatic or renal insufficiency and a total bilirubin and serum creatinine no greater than 2.5 mg/dL and SGOT/SGPT no greater than 5 times upper limit of normal * Must have recovered from adverse effect of previous therapy * At least 8 weeks elapsed since last dose of radiation * At least 4 weeks elapsed since last dose of chemotherapy (6 weeks for nitrosoureas) * Corticosteroids permitted using the smallest dose that is compatible with preservation of optimal neurologic function * Acceptable methods of birth control (in females of child-bearing potential or in sexually active males)during and up to four weeks following completion of study Exclusion Criteria: * Prior A10 and AS2-1 treatment * Severe heart disease * Uncontrolled hypertension * Lung disease * Hepatic failure * Serious active infections, fever or other serious concurrent disease that would interfere with the evaluation of the treatment drug. * Pregnant or nursing * Serious concurrent disease * Concurrent antineoplastic or immunomodulatory agents
References
Publications (0)
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