Antineoplaston Therapy in Treating Patients With Metastatic or Unresectable Colon Cancer
|ClinicalTrials.gov Identifier: NCT00003485|
Recruitment Status : Terminated (slow accrual)
First Posted : January 27, 2003
Last Update Posted : September 28, 2017
Current therapies for metastatic or unresectable Colon Cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of metastatic or unresectable Colon Cancer.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with metastatic or unresectable Colon Cancer
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer||Drug: antineoplaston A10, antineoplaston AS2-1 (ANP)||Phase 2|
OVERVIEW: This is a single arm, open-label study in which patients with metastatic or unresectable Colon Cancer cancer receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to12 months in the absence of disease progression or unacceptable toxicity.
- To determine the efficacy of Antineoplaston therapy in patients with metastatic or unresectable Colon Cancer, as measured by an objective response to therapy (complete response, partial response or stable disease).
- To determine the safety and tolerance of Antineoplaston therapy in patients with metastatic or unresectable Colon Cancer.
- To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Adenocarcinoma of the Colon|
|Actual Study Start Date :||April 10, 1996|
|Primary Completion Date :||May 11, 2003|
|Study Completion Date :||May 11, 2003|
Experimental: Antineoplaston therapy
Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Drug: antineoplaston A10, antineoplaston AS2-1 (ANP)
Patients with metastatic or unresectable Colon Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).
The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Other Name: Antineoplaston therapy (Atengenal + Astugenal)ANP
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003485
|United States, Texas|
|Houston, Texas, United States, 77055-6330|
|Principal Investigator:||Stanislaw R. Burzynski, MD, PhD||Burzynski Research Institute|