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| Descriptive Information Fields | |||||
| Brief Title † | Antineoplaston Therapy in Treating Patients With Cancer of the Esophagus | ||||
| Official Title † | Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Adenocarcinoma of the Esophagus | ||||
| Brief 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 cancer of the esophagus. |
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| Detailed Description | OBJECTIVES:
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. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Open Label | ||||
| Primary Outcome Measure † | Response rate based on tumor measurements taken at 12 weeks [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Survival at 1, 2, and 5 years from the start of treatment [ Designated as safety issue: No ] | ||||
| Condition † | Esophageal Cancer | ||||
| Intervention † | Drug: antineoplaston A10 Drug: antineoplaston AS2-1 |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 40 | ||||
| Start Date † | May 1996 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00003487 | ||||
| Organization ID | CDR0000066525 | ||||
| Secondary IDs †† | BC-ES-2 | ||||
| Study Sponsor † | Burzynski Research Institute | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | October 2008 | ||||
| First Received Date † | November 1, 1999 | ||||
| Last Updated Date | October 24, 2008 | ||||