Antineoplaston Therapy in Treating Patients With Cancer of the Esophagus
Adenocarcinoma of the Esophagus
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Esophagus focused on measuring esophageal cancer, recurrent esophageal cancer, stage IV esophageal cancer
Eligibility 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
Sites / Locations
- Burzynski Clinic
Arms of the Study
Arm 1
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.