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Phase II Study of Antineoplastons A19 and AS2-1 in Patients With Neurofibroma and Schwannoma
RATIONALE: Current therapies for adults with a recurrent/residual Neurofibroma or Schwannoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with a recurrent/residual Neurofibroma or Schwannoma. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with a recurrent/residual Neurofibroma or Schwannoma.
OVERVIEW: This is a single arm, open-label study in which adults with a recurrent/residual Neurofibroma or Schwannoma 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 with a recurrent/residual Neurofibroma or Schwannoma, 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 a recurrent/residual Neurofibroma or Schwannoma. * 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.
Age
18 - 99 years
Sex
ALL
Healthy Volunteers
No
Burzynski Clinic
Houston, Texas, United States
Start Date
March 1, 1999
Primary Completion Date
August 1, 2001
Completion Date
August 1, 2001
Last Updated
July 26, 2017
3
ACTUAL participants
Antineoplaston therapy (Atengenal + Astugenal)
DRUG
Lead Sponsor
Burzynski Research Institute
NCT07236840
NCT06441331
Data Source & Attribution
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