Antineoplaston Therapy in Treating Children With Primitive Neuroectodermal Tumors
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 children with primitive neuroectodermal tumors that has not responded to standard therapy.
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 In Children With Primitive Neuroectodermal Tumors|
- Response rate assessed by tumor measurements at 12 weeks [ Designated as safety issue: No ]
- Survival at 1, 2, and 5 years after start of treatment [ Designated as safety issue: No ]
|Study Start Date:||September 1995|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
- Demonstrate the antitumor activity of antineoplastons A10 and AS2-1 in children with primitive neuroectodermal tumors by determining the proportion of patients who experience an objective tumor response.
- Evaluate the adverse effects of and tolerance to 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 a day until the maximum tolerated dose is reached. Treatment continues for at least 2 months in the absence of disease progression or unacceptable toxicity. After 2 months, patients with responding or stable disease may continue treatment.
Tumors are measured every 8 weeks for 2 years, every 3 months for the third and fourth years, every 6 months for the fifth and sixth years, and then annually 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|