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

• Status: Terminated
• Trial end date: 1998-05-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Burzynski Research Institute

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