NCT00003515

Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors

Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Primitive Neuroectodermal Tumor Outside the Central Nervous System

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Burzynski Research Institute · Academic / Other
• Sex: All
• Age: 6 Months – 99 Years
• Healthy volunteers: Not accepted

Summary

Current therapies for Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors.

Detailed description

OVERVIEW: This is a single arm, open-label study in which patients with Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to12 months in the absence of disease progression or unacceptable toxicity. OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in patients with Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors, as measured by an objective response to therapy (complete response, partial response or stable disease). * To determine the safety and tolerance of Antineoplaston therapy in patients with Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors. * To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Conditions

• Primitive Neuroectodermal Tumor

Interventions

Type	Name	Description
DRUG	Antineoplaston therapy (Atengenal + Astugenal)	Patients With Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

Timeline

• Start date: 1996-12-12
• Primary completion: 1997-01-03
• Completion: 1997-01-03
• First posted: 2003-01-27
• Last updated: 2017-09-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study