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Antineoplaston Therapy in Treating Children With Primitive Neuroectodermal Tumors

Brain and Central Nervous System Tumors Clinical Trial

Official title:
Phase II Study of Antineoplastons A10 and AS2-1 In Children With Primitive Neuroectodermal Tumors

Clinical Trial 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 children with primitive neuroectodermal tumors that has not responded to standard therapy.

Clinical Trial Description

OBJECTIVES:

- 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. ;

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00003460
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Active, not recruiting
Phase Phase 2
Start date September 1995
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