Antineoplaston Therapy in Treating Patients With Metastatic or Unresectable Colon Cancer
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|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|
|Actual Primary Completion Date :||May 11, 2003|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|