Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Rare Diseases

Recurrence

Glioblastoma

Glioma

Brain Neoplasms

Astrocytoma

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Brain Tumor, Childhood

Anaplastic Astrocytoma

Neuroepithelioma

Childhood Brain Stem Glioma

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.

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

Antineoplaston therapy (Atengenal + Astugenal)

Stanislaw R. Burzynski, MD, PhD

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.

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

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

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.

Six months and Twelve months overall survival

Burzynski Research Institute

Eight patients were recruited between March 1996 and November 2011. All study subjects were seen at the Burzynski Clinic in Houston TX

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.

Antineoplaston therapy (Atengenal + Astugenal): Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).

Antineoplaston Therapy

Age, Continuous

Sex: Female, Male

S. R. Burzynski, MD, PhD

Partial Response

Stable Disease

Progressive Disease

Number of Participants With Objective Response

6 months overall survival

12 months overall survival

All study subjects receiving any Antineoplaston therapy

Percentage of Participants Who Survived

Overall Study

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Children with a recurrent/progressive high grade glioma will receive Antineoplaston therapy (Atengenal + Astugenal).

RATIONALE: Current therapies for children with recurrent/progressive high grade gliomas provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with recurrent/progressive high grade gliomas.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (\> 6 months of age) with recurrent/progressive high grade gliomas.

OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in children with recurrent/progressive high grade gliomas, 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 recurrent/progressive high grade gliomas.

OVERVIEW: This is a single arm, open-label study in which children with recurrent/progressive high grade gliomas 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 for this study.

Antineoplaston Therapy in Treating Children With Recurrent or Refractory High-Grade Glioma

Phase II Study of Antineoplastons A10 and AS2-1 in Children With High Grade Glioma

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.

6 months, 12 months, 24 months overall survival

Thirteen patients were recruited between April 1994 and August 1997. All study subjects were seen at the Burzynski Clinic in Houston TX

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.

Antineoplaston therapy (Atengenal + Astugenal): Children with a recurrent/progressive high grade glioma will receive Antineoplaston therapy (Atengenal + Astugenal).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Antineoplaston Therapy in Treating Children With Primary Malignant Brain Tumors	NCT00003476	Childhood Brain...	Antineoplaston ...	6 Months - 18 Years	Burzynski Research Institute
Antineoplaston Therapy in Treating Children With Recurrent or Refractory High-Grade Glioma	NCT00003535	High Grade Glio...	Antineoplaston ...	6 Months - 18 Years	Burzynski Research Institute
Antineoplaston Therapy in Treating Children With Recurrent or Refractory High-Grade Glioma	NCT00003535	High Grade Glio...	Antineoplaston ...	6 Months - 18 Years	Burzynski Research Institute

Spots Global Cancer Trial Database for childhood glioblastoma multiforme