Clinical trial · Interventional
Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Oligodendroglioma
Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Oligodendroglioma
NCT00003472CI-TRIAL-00032167terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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 adult recurrent/progressive oligodendrogliomas provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of childhood brain tumors. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adult recurrent/progressive oligodendrogliomas.
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 |
|---|---|---|---|
| Oligodendroglioma, Adult | Adult Oligodendroglioma | ONTOLOGY_EXACT | 0.98 |
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
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed incurable oligodendroglioma that progressed during or is recurrent or residual after initial therapy, including radiotherapy and/or chemotherapy * Measurable tumor by MRI scan performed within two weeks prior to study entry * Tumor must be at least 5 mm * No brain stem tumors PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * At least 2 months Hematopoietic: * WBC at least 2,000/mm\^3 * Platelet count at least 50,000/mm\^3 Hepatic: * Bilirubin no greater than 2.5 mg/dL * SGOT/SGPT no greater than 5 times upper limit of normal * No hepatic failure Renal: * Creatinine no greater than 2.5 mg/dL * No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: * No severe heart disease * No uncontrolled hypertension * No history of congestive heart failure * No history of other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: * No severe lung disease (e.g., chronic obstructive pulmonary disease) Other: * Not pregnant or nursing * Fertile patients must use effective contraception during and for 4 weeks after study participation * No serious active infections * No other serious concurrent disease PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * At least 4 weeks since prior immunotherapy Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy: * Concurrent corticosteroids allowed Radiotherapy: * See Disease Characteristics * At least 8 weeks since prior radiotherapy Surgery: * Recovered from any prior surgery Other: * No prior antineoplaston therapy
References
Publications (0)
Data not yet available
No reference posted for this study.