Trials / Withdrawn
WithdrawnNCT00003486
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
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Burzynski Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 colon cancer.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- First posted
- 2003-01-27
- Last updated
- 2013-07-10
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00003486. Inclusion in this directory is not an endorsement.