Conditions: Mixed Gliomas
Keywords: recurrent adult mixed glioma refractoy adult mixed glioma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 20
Healthy volunteers: no

Brief summary:
RATIONALE: Current therapies for adults with recurrent or refractory mixed 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 adults with recurrent or refractory mixed gliomas.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with recurrent or refractory mixed gliomas.

Detailed description:
OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in adults with recurrent or refractory mixed 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 adults with recurrent or refractory mixed gliomas.

OVERVIEW: This is a single arm, open-label study in which adults with recurrent or refractory mixed 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 to this study

Arms:
arm 1: 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.

Interventions: intervention 1: Atengenal intervention 2: Astugenal
Intervention descriptions: intervention 1: Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal). intervention 2: Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal).

Protocol document: