Glioblastoma Multiforme of the Brain Clinical Trial
Official title:
Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Glioblastoma Multiforme
RATIONALE: Current therapies for Glioblastoma Multiforme provide very limited benefit to the
patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove
beneficial in the treatment of brain tumors.
PURPOSE: This study is being performed to determine the effects (good and bad) that
Antineoplaston therapy has on adults (≥ 18 years of age) with residual/recurrent/progressive
Glioblastoma Multiforme.
OVERVIEW: This is a single arm, open-label study in which adults (≥ 18 years of age) with
residual/recurrent/progressed Glioblastoma Multiforme 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 adults (≥ 18 years of age) with
residual/recurrent/progressive Glioblastoma Multiforme following initial therapy,
including radiotherapy, 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 (≥ 18 years of
age) with residual/recurrent/progressive Glioblastoma Multiforme.
- 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.
;