NCT00003505

Antineoplaston Therapy in Treating Patients With Primary Central Nervous System Lymphoma

Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Primary Central Nervous System Lymphoma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Burzynski Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells. PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating patients with primary central nervous system lymphoma.

Detailed description

OBJECTIVES: * Assess the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening primary central nervous system lymphoma. * Describe response to, tolerance to, and side effects of this regimen in these patients. OUTLINE: This is an open-label study. Patients receive gradually escalating doses of intravenous antineoplaston A10 and antineoplaston AS2-1 6 times per day until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with responding or stable disease may continue treatment. Tumors are measured every 2 months for 6 months, every 3 months for 2 years, every 6 months for years 3 and 4, and then annually for years 5 and 6. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Conditions

• Primary Central Nervous System Lymphoma

Interventions

Type	Name	Description
DRUG	antineoplaston A10
DRUG	antineoplaston AS2-1
PROCEDURE	alternative product therapy
PROCEDURE	biological therapy
PROCEDURE	biologically based therapies
PROCEDURE	cancer prevention intervention
PROCEDURE	complementary and alternative therapy
PROCEDURE	differentiation therapy

Timeline

• First posted: 2003-01-27
• Last updated: 2013-07-10

Locations

1 site across 1 country: United States