Clinical trial · Interventional
Antineoplaston Therapy in Treating Adult Patients With Anaplastic Astrocytoma
Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Anaplastic Astrocytoma
NCT00003537CI-TRIAL-00029261AAcompletedPhase 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 anaplastic astrocytoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with anaplastic astrocytoma. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with anaplastic astrocytoma.
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 |
|---|---|---|---|
| Adult Brain Tumor | Adult Brain Neoplasm | 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; Stable Disease (SD), \<50% decrease and \<25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), \>=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed diagnosis of anaplastic astrocytoma * Tumor subtotally resected or biopsied prior to therapy * Evidence of residual tumor by MRI scan performed within two weeks prior to study entry * No brain stem tumors PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * More than 2 months Hematopoietic: * WBC at least 1,500/mm\^3 * Platelet count at least 50,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin no greater than 2.5 mg/dL * SGOT and SGPT no greater than 5 times upper limit of normal * No hepatic failure Renal: * Creatinine no greater than 2.5 mg/dL * No renal failure Cardiovascular: * No prior congestive heart failure * No coronary artery disease * No myocardial infarction within the past year * No angina requiring medication * No uncontrolled hypertension Pulmonary: * No moderate to severe chronic obstructive pulmonary disease Other: * Not pregnant or nursing * Fertile patients must use effective contraception during and for 4 weeks after study participation * No active infection * No other concurrent serious disease * No other prior malignancy except carcinoma in situ of the cervix or superficial nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunotherapy * No concurrent immunomodulating agents Chemotherapy: * No prior myelosuppressive chemotherapy Endocrine therapy: * Concurrent corticosteroids for cerebral edema allowed Radiotherapy: * No prior myelosuppressive radiotherapy * No concurrent radiotherapy Surgery: * See Disease Characteristics * Recovered from any prior surgery Other: * No prior cytodifferentiating agents * No prior antineoplaston therapy * No other concurrent antineoplastic agents
References
Publications (1)
- BACKGROUNDBurzynski SR, Janicki TJ, Burzynski GS, Marszalek A. A Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients with Newly-Diagnosed Anaplastic Astrocytoma Final Report (Protocol BT-08). Cancer and Clinical Oncology 4: 28-38, 2015. DOI: http://dx.doi.org/10.5539/cco.v4n1p28