NCT00003469

Antineoplaston Therapy in Treating Children With Rhabdoid Tumor of the Central Nervous System

Phase II Study of Antineoplastons A10 and AS2-1 in Children With Rhabdoid Tumor of the Central Nervous System

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Burzynski Research Institute · Academic / Other
• Sex: All
• Age: 6 Months – 17 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Current therapies for childhood Rhabdoid tumors provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of childhood Rhabdoid tumors. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (\> 6 months of age) with Rhabdoid tumors.

Detailed description

OVERVIEW: This is a single arm, open-label study in which children with Rhabdoid tumors receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in children with a Rhabdoid tumor, 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 children with a Rhabdoid tumor. * 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. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study.

Conditions

• Rhabdoid Neoplasm of CNS

Interventions

Type	Name	Description
DRUG	Antineoplaston therapy (Atengenal + Astugenal)	Children with a Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal).

Timeline

• Start date: 1996-02-01
• Primary completion: 2003-05-01
• Completion: 2003-05-01
• First posted: 2003-01-27
• Last updated: 2017-08-24
• Results posted: 2017-03-07

Locations

1 site across 1 country: United States