NCT00003501

Antineoplaston Therapy in Treating Patients With High-Grade Stage II - Stage IV Non-Hodgkin's Lymphoma

Phase II Study of Antineoplaston A10 and AS2-1 in Patients With Non-Hodgkin's Lymphoma, High Grade

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

Summary

Current therapies for Refractory or Recurrent High-Grade Stage II - IV Non-Hodgkin's Lymphoma provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Refractory or Recurrent High-Grade Stage II - IV Non-Hodgkin's Lymphoma. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Refractory or Recurrent High-Grade Stage II - IV Non-Hodgkin's Lymphoma.

Detailed description

Refractory or Recurrent High-Grade Stage II - IV Non-Hodgkin's Lymphoma patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to12 months in the absence of disease progression or unacceptable toxicity. OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in patients with Refractory or Recurrent High-Grade Stage II - IV Non-Hodgkin's Lymphoma, 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 Refractory or Recurrent High-Grade Stage II - IV Non-Hodgkin's Lymphoma. * To determine objective response, tumor size is measured utilizing physical examination, radiologic studies, and bone marrow biopsies as necessary, 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.

Conditions

• Non-hodgkins Lymphoma

Interventions

Type	Name	Description
DRUG	Antineoplaston therapy (Atengenal + Astugenal)	Patients with Refractory or Recurrent High-Grade Stage II - IV Non-Hodgkin's Lymphoma 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: 2003-07-02
• Completion: 2003-07-02
• First posted: 2003-01-27
• Last updated: 2018-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study