Clinical trial · Interventional
Antineoplaston Therapy in Treating Children With Primitive Neuroectodermal Tumors
Phase II Study of Antineoplastons A10 and AS2-1 In Children With Primitive Neuroectodermal Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Current therapies for children with primitive neuroectodermal tumors that have not responded to standard therapy 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 primitive neuroectodermal tumors that have not responded to standard therapy. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (\> 6 months of age) with primitive neuroectodermal tumors that has not responded to standard therapy.
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 |
|---|---|---|---|
| Childhood CNS Primitive Neuroectodermal Tumor | Childhood Central Nervous System Embryonal Tumor, Not Otherwise Specified | ALIAS | 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
- 17 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed (except if medically contraindicated) incurable primitive neuroectodermal tumor * Evidence of progressive or recurrent tumor by MRI scan performed within 2 weeks prior to study entry * Must have received and failed prior standard therapy * Tumor must be at least 5 mm PATIENT CHARACTERISTICS: Age: * 6 months to 17 years Performance status: * Karnofsky 60-100% Life expectancy: * At least 2 months Hematopoietic: * WBC at least 2000/mm\^3 * Platelet count greater than 50,000/mm\^3 Hepatic: * Bilirubin no greater than 2.5 mg/dL * SGOT and SGPT no greater than 5 times upper limit of normal * No hepatic insufficiency Renal: * Creatinine no greater than 2.5 mg/dL * No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: * No uncontrolled hypertension * No severe heart disease * No history of congestive heart failure * No other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: * No severe lung disease Other: * Not pregnant or nursing * Fertile patients must use effective contraception during and for 4 weeks after study participation * No serious active infections or fever * No other serious concomitant disease PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy and recovered * No concurrent immunomodulating agents Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered * No concurrent antineoplastic agents Endocrine therapy: * Concurrent corticosteroids for cerebral edema allowed (must be on a stable dose for at least 1 week prior to study entry) Radiotherapy: * At least 8 weeks since prior radiotherapy and recovered Surgery: * Not specified Other: * No prior antineoplaston treatment
References
Publications (0)
Data not yet available