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

NCT01260103 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2017-07-26

No results posted yet for this study

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.

Conditions

  • Optic Nerve Glioma

Interventions

DRUG

Temozolomide

Study subjects in a fasting state receive TMZ orally once a day for five consecutive days (days 1 through 5) at a starting dose of 200 mg/m2/day. Treatment cycles are repeated every 28 days following the first daily dose of TMZ from the previous cycle. In the absence of PD or unacceptable toxicity, subjects continue to receive TMZ for a maximum of 13 cycles.

DRUG

ANP Therapy

Escalating doses of ANP therapy are administered for 52 weeks. If the study subject has an OR or maintains SD, ANP therapy is continued.

Sponsors & Collaborators

  • Burzynski Research Institute

    lead OTHER

Principal Investigators

  • Stanislaw R Burzynski, MD, PhD · Burzynski Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2016-12-31
Completion
2018-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01260103 on ClinicalTrials.gov