NCT00003492

Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer

Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Large Cell, Undifferentiated Or Poorly Differentiated Stage IV Carcinoma of the Lung

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Burzynski Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Current therapies for Stage IV Lung Cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Stage IV Pancreatic Cancer. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV Lung Cancer.

Detailed description

Stage IV Lung Cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity. OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in patients with Stage IV Lung Cancer, 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 patients with Stage IV Lung Cancer. * 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. Cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.

Conditions

• Stage IV Lung Cancer

Interventions

Type	Name	Description
DRUG	Antineoplaston therapy (Atengenal + Astugenal)	Patients with Stage IV Lung Cancer will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

Timeline

• Start date: 1996-04-10
• Primary completion: 2000-12-01
• Completion: 2000-12-01
• First posted: 2003-01-27
• Last updated: 2020-12-16
• Results posted: 2020-12-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study