Antineoplaston Therapy in Treating Patients With Refractory or Recurrent Intermediate-Grade Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
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 studies the effectiveness of antineoplaston therapy in treating patients who have refractory or recurrent intermediate-grade stage II, stage III, or stage IV non-Hodgkin's lymphoma.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Antineoplaston A10 and AS2-1 in Patients With Non-Hodgkin's Lymphoma, Intermediate Grade|
|Study Start Date:||August 1998|
- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life threatening refractory or recurrent intermediate grade non-Hodgkin's 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 antineoplaston A10 and antineoplaston AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached. Treatment continues for 12 months in the absence of disease progression or unacceptable toxicity. Patients achieving complete response, partial response, or stable disease continue treatment.
Tumors are measured at least every 8 weeks for 6 months, every 3 months for 1.5 years, every 6 months for 2 years, and then annually for 2 years.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003500
|United States, Texas|
|Houston, Texas, United States, 77055-6330|
|Study Chair:||Stanislaw R. Burzynski, MD, PhD||Burzynski Research Institute|