Stage IV Bladder Cancer Clinical Trial
Official title:
Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Bladder
Verified date | September 2017 |
Source | Burzynski Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 4 |
Est. completion date | May 4, 1998 |
Est. primary completion date | May 4, 1998 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Burzynski Clinic | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Burzynski Research Institute |
United States,
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