Phase 3 Study of ANP Therapy vs. TMZ for Optic Pathway Glioma

Summary

Primary Objectives To compare progression free survival (PFS), the time from randomization to progressive disease,in children with optic pathway glioma (OPG) age ≥ 6 months to \< 18 years, who receive combination antineoplaston therapy (ANP therapy) vs. temozolomide (TMZ); study subjects will have 1) received prior treatment with carboplatin or cisplatin, which was terminated secondary to toxicity or progression of OPG, or 2) developed recurrence of OPG after completion of carboplatin or cisplatin therapy. PFS data will be censored on the date of the last tumor assessment documenting absence of progression for study subjects: * Who are alive, on study and are progression-free at the time of the analysis; * Who discontinue, receive no subsequent therapy and are progression-free at the time of the analysis; * Who are given/change therapy other than the study treatment prior to observing progression; * Who discontinued (due to personal preference or toxicity) with a change in therapy, withdrew, or was lost to follow-up; * For whom documentation of disease progression or death occurs after ≥ 2 consecutive missed tumor assessments. * To describe the toxicity profile for ANP therapy vs. TMZ. Secondary Objectives: * To compare overall survival (OS) for subjects treated with ANP therapy vs. TMZ; * To compare disease stabilization rates for subjects treated with ANP therapy vs. TMZ; * To compare complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) rates for subjects treated with ANP therapy vs. TMZ.

Timeline

Start

2011-12

Primary completion

2016-12

Completion

2018-12

Drugs

Indications