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Sponsored by: |
Burzynski Research Institute |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003486 |
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 colon cancer.
Condition | Intervention | Phase |
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Stage IV Colon Cancer Recurrent Colon Cancer Adenocarcinoma of the Colon |
Drug: antineoplaston A10 Drug: antineoplaston AS2-1 Procedure: alternative product therapy Procedure: biological therapy Procedure: biologically based therapies Procedure: cancer prevention intervention Procedure: complementary and alternative therapy Procedure: differentiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Study of Antineoplastons A10 and AS2-1 Capsules in Patients With Adenocarcinoma of the Colon |
OBJECTIVES:
OUTLINE: This is an open-label study.
Patients receive gradually escalating doses of oral antineoplaston A10 and oral antineoplaston AS2-1 6-7 times a day. If the patient has not achieved a partial or complete response after 3-4 months of treatment, the investigator may discontinue treatment. Patients with stable disease may continue to receive treatment until disease progression or unacceptable toxicity is observed.
Tumors are measured every 4 months during the first 2 years, then every 6 months during years 3 and 4, and yearly during years 5 and 6.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Texas | |
Burzynski Clinic | |
Houston, Texas, United States, 77055-6330 |
Study Chair: | Stanislaw R. Burzynski, MD, PhD | Burzynski Research Institute |
Study ID Numbers: | CDR0000066524, BC-CO-3 |
Study First Received: | November 1, 1999 |
Last Updated: | December 4, 2006 |
ClinicalTrials.gov Identifier: | NCT00003486 History of Changes |
Health Authority: | United States: Federal Government |
Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Recurrence Intestinal Neoplasms Carcinoma |
Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Colonic Neoplasms Colorectal Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Intestinal Neoplasms Carcinoma Neoplasms |
Neoplasms by Site Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Colonic Neoplasms Colorectal Neoplasms Neoplasms, Glandular and Epithelial |