Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Bladder

Stopped early · Phase 2

Conditions studied: Stage IV Bladder Cancer

In brief

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.

Key facts

Study ID

NCT00003452

Run by

Burzynski Research Institute

People needed

4

Starts

1996-05-06

Expected to finish

1998-05-04

Last updated by the study team

2017-09-28

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Prior antineoplaston therapy

Where it is running

• Burzynski Clinic — Houston, Texas, United States

Full record on ClinicalTrials.gov

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