Antineoplaston Therapy in Treating Patients With Cancer of the Esophagus
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|ClinicalTrials.gov Identifier: NCT00003487|
Recruitment Status : Terminated (Withdrawn due to slow enrollment)
First Posted : January 27, 2003
Last Update Posted : December 18, 2013
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 cancer of the esophagus.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Drug: antineoplaston A10 Drug: antineoplaston AS2-1||Phase 2|
- Provide antineoplastons A10 and AS2-1 as treatment for patients with incurable adenocarcinoma of the esophagus.
- Describe the response to, tolerance to, and side effects of this regimen in these patients.
OUTLINE: This is an open-label study.
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 2 months in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) continue treatment for at least 8 months beyond CR. Patients achieving a partial response or stable disease continue treatment until disease progression.
Tumors are measured every 2 months for 1 year and then every 3 months for the second year.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Adenocarcinoma of the Esophagus|
|Study Start Date :||May 1996|
|Estimated Primary Completion Date :||December 2011|
- Response rate based on tumor measurements taken at 12 weeks
- Survival at 1, 2, and 5 years from the start of treatment
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): NCT00003487
|United States, Texas|
|Houston, Texas, United States, 77055-6330|
|Study Chair:||Stanislaw R. Burzynski, MD, PhD||Burzynski Research Institute|