Expired Study
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Houston, Texas 77055


Purpose:

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.


Study summary:

OBJECTIVES: - 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.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the esophagus that is unlikely to respond to existing therapy and for which no curative therapy exists - Meets 1 of the following criteria: - Metastatic disease - Not curable with surgery or radiotherapy - Measurable disease by MRI or CT scan PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 2 months Hematopoietic: - WBC at least 2000/mm3 - Platelet count at least 50,000/mm3 Hepatic: - No hepatic failure - Bilirubin no greater than 2.5 mg/dL - SGOT and SGPT no greater than 5 times upper limit of normal Renal: - Creatinine no greater than 2.5 mg/ml - No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: - No chronic or congestive heart failure - No uncontrolled hypertension - No other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: - No serious lung disease, such as severe chronic obstructive pulmonary disease Other: - Not pregnant or nursing - Fertile patients must use effective contraception during and for 4 weeks after study participation - No medical illness, psychiatric illness, or non-malignant systemic disease that would preclude study treatment - No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy and recovered Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered Endocrine therapy: - Concurrent steroids allowed Radiotherapy: - At least 8 weeks since prior radiotherapy (except in patients with multiple tumors who have received radiotherapy to some of their tumors) and recovered Surgery: - Recovered from prior surgery Other: - No prior antineoplaston therapy - Prior cytodifferentiating agents allowed


NCT ID:

NCT00003487


Primary Contact:

Study Chair
Stanislaw R. Burzynski, MD, PhD
Burzynski Research Institute


Backup Contact:

N/A


Location Contact:

Houston, Texas 77055
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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