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

Stage IV Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00003452
• Other study ID #: CDR0000066483
• Secondary ID: BC-BL-02
• Status: Terminated
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: September 26, 2017
• Start date: May 6, 1996
• Est. completion date: May 4, 1998

Study information

• Verified date: September 2017
• Source: Burzynski Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Stage IV Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• Antineoplaston therapy (Atengenal + Astugenal)
Patients with Stage IV Bladder Cancer will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

Locations

Country	Name	City	State
United States	Burzynski Clinic	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Burzynski Research Institute

Country where clinical trial is conducted

United States, 

External Links

•   Burzynski Clinic
•   Burzynski Research Institute