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

Sponsor
Burzynski Research Institute (Other)
Overall Status
Terminated
CT.gov ID
NCT00003452
Collaborator
(none)
4
Enrollment
1
Location
1
Arm
23.9
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Antineoplaston therapy (Atengenal + Astugenal)
 Phase 2

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Bladder
Actual Study Start Date :
May 6, 1996
Actual Primary Completion Date :
May 4, 1998
Actual Study Completion Date :
May 4, 1998

Arms and Interventions

Arm Intervention/Treatment
Experimental: Antineoplastons

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)
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.
Other Names:
  • A10 (Atengenal); AS2-1 (Astugenal)

    		•

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 99 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Burzynski Clinic Houston Texas United States 77055-6330

      Sponsors and Collaborators

      • Burzynski Research Institute

      Investigators

      • Principal Investigator: Stanislaw R. Burzynski, MD, PhD, Burzynski Research Institute

      Study Documents (Full-Text)

      None provided.

      More Information

      Additional Information:

      Publications

      None provided.
      Responsible Party:
      Burzynski Research Institute
      ClinicalTrials.gov Identifier:
      NCT00003452
      Other Study ID Numbers:
      • CDR0000066483
      • BC-BL-02
      First Posted:
      Jan 27, 2003
      Last Update Posted:
      Sep 28, 2017
      Last Verified:
      Sep 1, 2017
      Individual Participant Data (IPD) Sharing Statement:
      No
      Plan to Share IPD:
      No
      Studies a U.S. FDA-regulated Drug Product:
      Yes
      Studies a U.S. FDA-regulated Device Product:
      No
      Keywords provided by Burzynski Research Institute
      recurrent bladder cancer
      Additional relevant MeSH terms:
      Urinary Bladder Neoplasms

      Study Results

      No Results Posted as of Sep 28, 2017