Antineoplaston Therapy in Treating Children With Primary Malignant Brain Tumors
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|ClinicalTrials.gov Identifier: NCT00003476|
Recruitment Status : Terminated (Slow accrual)
First Posted : January 27, 2003
Results First Posted : April 10, 2017
Last Update Posted : August 24, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Childhood Brain Tumor||Drug: Antineoplaston therapy (Atengenal + Astugenal)||Phase 2|
- 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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Antineoplastons A10 and AS2-1 in Children With Primary Malignant Brain Tumors|
|Study Start Date :||March 1996|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Experimental: Antineoplaston therapy
Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Drug: Antineoplaston therapy (Atengenal + Astugenal)
Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).
Other Name: A10 (Atengenal); AS2-1 (Astugenal)
- Number of Participants With Objective Response [ Time Frame: 12 months ]Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), <50% decrease and <25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.
- Percentage of Participants Who Survived [ Time Frame: 6 months, 12 months ]Six months and Twelve months overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003476
|United States, Texas|
|Houston, Texas, United States, 77055-6330|
|Principal Investigator:||Stanislaw R. Burzynski, MD, PhD||Burzynski Research Institute|