NCT00003511

Antineoplaston Therapy in Treating Patients With Multiple Myeloma

Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Multiple Myeloma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Burzynski Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Multiple Myeloma 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 Multiple Myeloma, 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 Multiple Myeloma. * 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

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Antineoplaston therapy (Atengenal + Astugenal)	Patients with Multiple Myeloma 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: 1996-04-04
• Primary completion: 1999-10-21
• Completion: 1999-10-21
• First posted: 2003-01-27
• Last updated: 2021-06-09
• Results posted: 2021-01-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study