Neoplasms

Nervous System Diseases

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Rare Diseases

Central Nervous System Neoplasms

Rhabdoid Tumor

Nervous System Neoplasms

Neoplasms by Histologic Type

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 Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal).

Antineoplaston therapy (Atengenal + Astugenal)

Stanislaw R. Burzynski, MD, PhD

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.

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.

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

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

Burzynski Research Institute

Four patients were recruited between February 1996 and October 2010. 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 Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Antineoplaston Therapy in Treating Children With Rhabdoid Tumor of the Central Nervous System	NCT00003469	Rhabdoid Neopla...	Antineoplaston ...	6 Months - 17 Years	Burzynski Research Institute
Antineoplaston Therapy in Treating Children With Rhabdoid Tumor of the Central Nervous System	NCT00003469	Rhabdoid Neopla...	Antineoplaston ...	6 Months - 17 Years	Burzynski Research Institute

Spots Global Cancer Trial Database for childhood rhabdoid tumor