Antineoplaston Therapy in Treating Patients With Cancer of the Esophagus
Condition: Adenocarcinoma of the Esophagus
MeSH terms: Adenocarcinoma; Esophageal Neoplasms
Intervention: Antineoplaston therapy (Atengenal + Astugenal)
Intervention description: Patients with Adenocarcinoma of the Esophagus 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: esophageal cancer; recurrent esophageal cancer; stage IV esophageal cancer

Summary:

      Current therapies for Adenocarcinoma of the Esophagus provide limited benefit to the patient.
      The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in
      the treatment of Adenocarcinoma of the Esophagus.

      PURPOSE: This study is being performed to determine the effects (good and bad) that
      Antineoplaston therapy has on patients with Adenocarcinoma of the Esophagus.
    

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