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Antineoplaston Therapy in Treating Patients With Stage IV Bladder Cancer or Stage IV Newly Diagnosed, Incurable Bladder Cancer

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 work in treating patients with stage IV bladder cancer or newly diagnosed stage IV bladder cancer.

Description

OBJECTIVES:

- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with stage IV bladder carcinoma or stage IV newly diagnosed, incurable bladder carcinoma.

- Describe 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 by intravenous injection over a minimum of 1 hour 6 times daily until the maximum tolerated dose is reached.

Treatment continues for at least 3 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.

X-rays or scans are performed every 2 months for 1 year and then every 3 months for the second year.

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Bladder Cancer

Intervention

antineoplaston A10, antineoplaston AS2-1

Location

Burzynski Clinic
Houston
Texas
United States
77055-6330

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

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

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Medical and Biotech [MESH] Definitions

Tumors or cancer of the URINARY BLADDER.

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An abnormal passage in the URINARY BLADDER or between the bladder and any surrounding organ.

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