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Antineoplaston Therapy in Treating Patients With Neuroendocrine Tumor That Is Metastatic or Unlikely to Respond to Surgery or Radiation Therapy

2014-07-24 14:35:58 | 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 neuroendocrine tumor that is metastatic or unlikely to respond to surgery or radiation therapy.

Description

OBJECTIVES:

- Provide treatment with antineoplastons A10 and AS2-1 for patients with metastatic or incurable neuroendocrine tumors.

- Describe response, tolerance to, and side effects of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive gradually escalating doses of antineoplastons A10 and AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached.

Treatment continues for at least 2 months in the absence of unacceptable toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR.

Tumors are measured every 2 months for 1 year and then every 3 months for 1 year.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.

Study Design

Primary Purpose: Treatment

Conditions

Merkel Cell Carcinoma

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Withdrawn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: 2014-07-24T14:35:58-0400

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