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

NCT00003452 | Terminated Phase 2 FDA Drug

• 2 other identifiers: CDR0000066483BC-BL-02
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stage IV Bladder Cancer

Keywords

recurrent bladder cancer

Study Arms (1)

Antineoplastons

EXPERIMENTAL

Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.

Drug: Antineoplaston therapy (Atengenal + Astugenal)

Interventions

Antineoplaston therapy (Atengenal + Astugenal) DRUG

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.

Also known as: A10 (Atengenal); AS2-1 (Astugenal)

Antineoplastons

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

You may not qualify if:

• \- Prior antineoplaston therapy

Sponsors & Collaborators

• Burzynski Research Institute: lead

Study Sites (1)

Burzynski Clinic

Houston, Texas, 77055-6330, United States

Location

Related Links

• Burzynski Research Institute
• Burzynski Clinic

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

antineoplaston A10; antineoplaston AS 2-1

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Stanislaw R. Burzynski, MD, PhD

  Burzynski Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: May 6, 1996
• Primary Completion: May 4, 1998
• Study Completion: May 4, 1998
• Last Updated: September 28, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)