NCT00003476

Antineoplaston Therapy in Treating Children With Primary Malignant Brain Tumors

Phase II Study of Antineoplastons A10 and AS2-1 in Children With Primary Malignant Brain Tumors

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Burzynski Research Institute · Academic / Other
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in children with primary malignant brain 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 children with primary malignant brain tumors. OVERVIEW: This is a single arm, open-label study in which children with primary malignant brain 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. After 12 months, patients with a complete or partial response or with stable disease may continue treatment. 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

• Childhood Brain Tumor

Interventions

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

Timeline

• Start date: 1996-03-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2003-01-27
• Last updated: 2017-08-24
• Results posted: 2017-04-10

Locations

1 site across 1 country: United States