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Antineoplaston Therapy in Treating Patients With Mantle Cell Lymphoma

2014-08-27 03:58:40 | BioPortfolio

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 stage II, stage III, or stage IV mantle cell lymphoma.

Description

OBJECTIVES:

- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening stage II, III, or IV mantle cell lymphoma.

- Evaluate the 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 intravenously 6 times daily until the maximum tolerated dose is reached. Treatment continues in the absence of disease progression or unacceptable toxicity.

Tumors are measured every 8 weeks for 6 months, every 3 months for 2 years, every 6 months for the third and fourth years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Study Design

Primary Purpose: Treatment

Conditions

Contiguous Stage II Mantle Cell Lymphoma

Intervention

antineoplaston A10, antineoplaston AS2-1, alternative product therapy, biological therapy, biologically based therapies, cancer prevention intervention, complementary and alternative therapy, differentiation therapy

Location

Burzynski Clinic
Houston
Texas
United States
77055-6330

Status

Withdrawn

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:58:40-0400

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