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| Sponsor: | Burzynski Research Institute |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003485 |
Purpose
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 studies the effectiveness of antineoplaston therapy in treating patients who have metastatic or unresectable colon cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: antineoplaston A10 Drug: antineoplaston AS2-1 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Adenocarcinoma of the Colon |
| Estimated Enrollment: | 40 |
| Study Start Date: | August 1998 |
OBJECTIVES:
OUTLINE: Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression. Patients achieving complete response (CR) continue treatment for at least 8 months after reaching CR.
Tumors are measured at least every 2 months for 1 year and then every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Eligibility| 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:
Contacts and Locations| United States, Texas | |
| Burzynski Clinic | |
| Houston, Texas, United States, 77055-6330 | |
| Study Chair: | Stanislaw R. Burzynski, MD, PhD | Burzynski Research Institute |
More Information
| Study ID Numbers: | CDR0000066523, BC-CO-2 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003485 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV colon cancer recurrent colon cancer adenocarcinoma of the colon |
|
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Colonic Neoplasms Intestinal Neoplasms Colorectal Neoplasms |