Esophageal Cancer Clinical Trial
Antineoplaston Therapy in Treating Patients With Cancer of the Esophagus
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.
Full Description
Esophageal cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.
OBJECTIVES:
To determine the efficacy of Antineoplaston therapy in patients with esophageal cancer, as measured by an objective response to therapy (complete response, partial response or stable disease).
To determine the safety and tolerance of Antineoplaston therapy in patients with Esophageal Cancer.
To determine objective response, tumor size is measured utilizing physical examination, and radiologic studies performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.
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
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There is 1 Location for this study
Houston Texas, 77055, United States
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