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| Sponsor: | Burzynski Research Institute |
|---|---|
| Information provided by: | Burzynski Research Institute |
| ClinicalTrials.gov Identifier: | NCT01260103 |
Purpose
The purpose of this study is 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Optic Nerve Glioma |
Drug: Temozolomide Drug: Antineoplaston A10 and Antineoplaston AS2-1 (ANP) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase 3 Study of Combination Antineoplaston Therapy [Antineoplastons A10 (Atengenal) and AS2-1 (Astugenal)] vs. Temozolomide in Subjects With Recurrent and / or Progressive Optic Pathway Glioma After Carboplatin or Cisplatin Therapy |
| Estimated Enrollment: | 70 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Temozolomide (TMZ)
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 to a maximum of 26 cycles. |
Drug: Temozolomide
Study subjects in a fasting state receive temozolomide (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
Other Names:
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Experimental: Antineoplastons (ANP)
Combination antineoplaston therapy: [Antineoplaston A10 (Atengenal) and Antineoplaston AS2-1 (Astugenal)] given six times daily (open label) by subclavian vein infusion.
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Drug: Antineoplaston A10 and Antineoplaston AS2-1 (ANP)
A central venous catheter is placed prior to initiation of ANP therapy. ANP therapy is administered via a dual channel infusion pump. The infusion pump is programmed once every 24 hours with the daily doses of A10 and AS2-1 being divided into six infusions, at 4-hourly intervals. ANP therapy administration is according to the following schedule: Day 1: The starting (loading) dose for A10 is 60 mL/day (300 mg/mL) and for AS2-1 is 60 mL (80 mg/mL). Day 2: A10 is administered at 7 mL/kg/day (2.1 g/kg/day), while AS2-1 is administered at 5 mL/kg/day (0.4 g/kg/day). Day 3 and subsequent days: The A10 dose is increased by 7 mL/kg/day (2.1 g/kg/day) daily until the maximum tolerated dose is reached, not exceeding 70 mL/kg/day (21 g/kg/day). Other Names:
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Eligibility| Ages Eligible for Study: | 6 Months to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Children with normal organ and marrow function (as defined below) are eligible.
Exclusion Criteria:
Contacts and Locations| Contact: Stanislaw R Burzynski, MD PhD | 713-335-5697 | srb@burzynskiclinic.com |
| United States, Texas | |
| Burzynski Research Institute, Inc | Not yet recruiting |
| Houston, Texas, United States, 77055 | |
| Contact: Stanislaw R Burzynski, M.D., Ph.D. 713-335-5697 srb@burzynskiclinic.com | |
| Burzynski Clinic | Not yet recruiting |
| Houston, Texas, United States, 77055 | |
| Contact: Stanislaw R Burzynski, M.D., Ph.D. 713-335-5697 srb@burzynskiclinic.com | |
More Information
| Responsible Party: | Stanislaw R. Burzynski M.D. Ph.D., Burzynski Research Institute, Inc. |
| ClinicalTrials.gov Identifier: | NCT01260103 History of Changes |
| Other Study ID Numbers: | BRI-BT-54 |
| Study First Received: | December 13, 2010 |
| Last Updated: | December 13, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Optic pathway glioma recurrent Optic pathway glioma progressed Temozolomide Temodar TMZ |
Antineoplastons ANP Atengenal Astugenal |
|
Glioma Optic Nerve Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Astrocytoma Optic Nerve Neoplasms Cranial Nerve Neoplasms Nervous System Neoplasms Neoplasms by Site |
Peripheral Nervous System Neoplasms Cranial Nerve Diseases Nervous System Diseases Optic Nerve Diseases Eye Diseases Temozolomide Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |