Clinical trial · Interventional
Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas
Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Mixed Glioma
NCT00003473CI-TRIAL-00031218completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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 adults with recurrent or refractory mixed 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 adults with recurrent or refractory mixed gliomas. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with recurrent or refractory mixed 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 |
|---|---|---|---|
| Mixed Gliomas | Glioma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Astugenal | Drug | — | UNRESOLVED |
| Atengenal | 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: Atengenal
- Drug: 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
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed incurable primary mixed glioma that is recurrent or refractory following standard therapy, including radiation therapy * Evidence of recurrent or refractory tumor by MRI scan performed within two weeks prior to study entry * Must have received and failed standard therapy * Tumor must be at least 5 mm PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * At least 2 months Hematopoietic: * WBC at least 2000/mm3 * Platelet count at least 50,000/mm3 Hepatic: * No hepatic insufficiency * Bilirubin no greater than 2.5 mg/mL * SGOT and SGPT no greater than 5 times upper limit of normal Renal: * No renal insufficiency * Creatinine no greater than 2.5 mg/mL * No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: * No known chronic heart failure * No uncontrolled hypertension * No history of congestive heart failure * No other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: * No severe lung disease * No severe chronic obstructive pulmonary disease Other: * Not pregnant or nursing * Fertile patients must use effective contraception during and for 4 weeks after study * No other severe medical illness * No nonmalignant systemic disease * No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since immunotherapy Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy: * Concurrent corticosteroids allowed Radiotherapy: * At least 8 weeks since prior radiotherapy (unless there is evidence of disease progression) Surgery: * Fully recovered from prior surgery Other: * Prior cytodifferentiating agent allowed * No prior antineoplaston therapy
References
Publications (0)
Data not yet available
No reference posted for this study.