A Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Newly-Diagnosed Anaplastic Astrocytoma-Final Report (Protocol BT-08)
Bibliographic record
Abstract
The paper reports the evaluation of efficacy and safety of Antineoplastons A10 and AS2-1 (ANP) in a phase II study of newly diagnosed patients with anaplastic astrocytoma (AA). The study was designed as a single-arm, two-stage, phase II trial of ANP as monotherapy. The primary endpoint, was to determine the overall response rate (confirmed complete response (CR) or partial response (PR)) to ANP, based on disappearance or more than 50% reduction of tumor size by contrast-enhanced magnetic resonance imaging (MRI). The goal of the study was a response rate to ANP of not less than 10% or 4 patients. 19 patients (12 men, 7 women) ages 22-60 years (median age, 44) were treated. The patients received ANP daily every four hours (median dose of A10 5.3 g/kg/d and AS2-1 0.3 g/kg/d). The duration of ANP ranged from 3 to 175 weeks. A complete response was documented in 21%, and stable disease in 26% of patients. The study was closed for enrollment after 19 of its subjects had been admitted, because the goal of trial had been accomplished. Progression-free survival and overall survival at 2 years was 16% and 37% and at 10 years was 5% and 14% respectively. Only 11% of patients reported grade 3 toxicities consisting of hypokalemia and fatigue, and 11% reported grade 4 toxicities consisting of hypernatremia and hypokalemia. There was no chronic toxicity and there was a high quality of life. ANP shows efficacy with very good toxicity profile in patients with newly diagnosed AA.
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How this classification was reachedexpand
Direct model labels (unvalidated)
Per-model category and study-design labels from the labeling rounds. They are machine output, unvalidated, and the disagreement between models ships as data. No study design here is MEDLINE-validated yet.
| Model arm | Categories | Study design | Confidence |
|---|---|---|---|
| gemma | no category Domain: not available · Genre: Empirical About the Canadian research system: no · About a Canadian topic: no | Randomized trial | high |
| gpt | no category Domain: not available · Genre: Empirical About the Canadian research system: no · About a Canadian topic: no | Other design | medium |
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedLabeled directly by 2 models reading the full record.
The models disagree on parts of this classification; every voice is preserved in the section at the end of the page.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".