Bladder Cancer Clinical Trial
Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Bladder
Summary
Current therapies for Stage IV bladder cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Stage IV bladder cancer
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV bladder cancer.
Full Description
Stage IV bladder 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 Stage IV bladder 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 Stage IV bladder cancer.
To determine objective response, tumor size is measured utilizing MRI scans, which are 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
Inclusion Criteria:
Histologically confirmed stage IV bladder carcinoma that is unlikely to respond to existing therapy and for which no curative therapy exists or stage IV newly diagnosed, incurable bladder carcinoma
Measurable disease by CT scan
Tumor must be greater than 2 cm at the largest diameter for the lymph nodes located in the head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm in the largest diameter for other localizations
18 and over
Karnofsky 60-100%
Life expectancy: greater than 2 months
WBC at least 2,000/mm^3
Platelet count at least 50,000/mm^3
Bilirubin no greater than 2.5 mg/dL
SGOT/SGPT no greater than 5 times upper limit of normal
No hepatic failure
Creatinine no greater than 2.5 mg/dL
No history of renal conditions that contraindicate high dosages of sodium
No severe heart disease
No uncontrolled hypertension
No history of congestive heart failure
No history of other cardiovascular conditions that contraindicate high dosages of sodium
No severe lung disease
Not pregnant or nursing
Fertile patients must use effective contraception during and for 4 weeks after study participation
No serious active infections or fever
No other serious concurrent disease
At least 4 weeks since prior immunotherapy and recovered
No concurrent immunomodulating agents
At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
Concurrent corticosteroids allowed
At least 8 weeks since prior radiotherapy and recovered
Recovered from any prior operative procedure
Prior cytodifferentiating agent allowed
Exclusion Criteria:
- Prior antineoplaston therapy
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There is 1 Location for this study
Houston Texas, 77055, United States
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