- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003486
Antineoplaston Therapy in Treating Patients With Colon Cancer
Phase II Study of Antineoplastons A10 and AS2-1 Capsules in Patients With Adenocarcinoma of the Colon
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the antitumor activity of antineoplastons A10 and AS2-1 in patients with adenocarcinoma of the colon by determining the proportion of patients who experience an objective tumor response.
- Evaluate the adverse effects of and tolerance to this regimen in these patients.
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77055-6330
- Burzynski Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the colon that is unlikely to respond to existing therapy and for which no curative therapy exists
- Measurable disease by MRI or CT scan
- Metastatic or unresectable disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 2 months
Hematopoietic:
- WBC at least 2,000/mm^3
- Platelet count at least 50,000/mm^3
Hepatic:
- Bilirubin no greater than 2.5 mg/dL
- SGOT/SGPT no greater than 5 times upper limit of normal
- No hepatic failure
Renal:
- Creatinine no greater than 2.5 mg/dL
- No renal failure
Cardiovascular:
- No chronic heart failure
- No uncontrolled hypertension
Pulmonary:
- No serious lung disease, such as chronic obstructive pulmonary disease
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 weeks after study participation
- No active infection
- No serious malabsorption syndromes
- No other serious concurrent disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy and recovered
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
Endocrine therapy:
- Concurrent corticosteroids allowed
Radiotherapy:
- At least 8 weeks since prior radiotherapy and recovered (patients with multiple tumors may be admitted earlier)
Surgery:
- No prior extensive stomach or intestinal surgery
Other:
- Prior cytodifferentiating agent allowed
- No prior antineoplaston therapy
- No other concurrent anticancer therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Stanislaw R. Burzynski, MD, PhD, Burzynski Research Institute
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Colorectal Neoplasms
- Adenocarcinoma
- Colonic Neoplasms
Other Study ID Numbers
- BC-CO-3
- CDR0000066524 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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