Antineoplaston Therapy in Treating Patients With Ependymoma
Recruitment status was Active, not recruiting
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 ependymoma.
Brain and Central Nervous System Tumors
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Antineoplastons A10 and AS2-1 Infusions in Patients With Ependymoma|
- Antitumor activity [ Designated as safety issue: No ]
- Adverse effects [ Designated as safety issue: Yes ]
- Treatment tolerance [ Designated as safety issue: Yes ]
|Study Start Date:||August 1998|
- Determine the antitumor activity of antineoplastons A10 and AS2-1 in patients with ependymoma by determining the proportion of patients who experience an objective tumor response.
- Evaluate the adverse side effects and tolerance to 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 at least 12 months in the absence of disease progression and unacceptable toxicity. After 12 months, patients with stable disease may continue treatment.
Tumors are measured at least every 8 weeks during the first 2 years, every 3 months during the third and fourth years, every 6 months during the fifth and sixth years, and yearly thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
|United States, Texas|
|Houston, Texas, United States, 77055-6330|
|Study Chair:||Stanislaw R. Burzynski, MD, PhD||Burzynski Research Institute|