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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Bladder Cancer

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Trial Information

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


OBJECTIVES:

- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in
patients with stage IV bladder carcinoma or stage IV newly diagnosed, incurable bladder
carcinoma.

- Describe response to, tolerance to, and side effects of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1
by intravenous injection over a minimum of 1 hour 6 times daily until the maximum tolerated
dose is reached.

Treatment continues for at least 3 months in the absence of unacceptable toxicity or disease
progression. Patients achieving complete response (CR) continue treatment for an additional
8 months after reaching CR.

X-rays or scans are performed every 2 months for 1 year and then every 3 months for the
second year.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued into this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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 MRI or 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

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 2 months

Hematopoietic:

- WBC at least 2,000/mm^3

- Platelet count at least 50,000/mm^3

Hepatic:

- Bilirubin no greater than 2.5 mg/dL

- SGOT/SGPT no greater than 5 times upper limit of normal

- No hepatic failure

Renal:

- Creatinine no greater than 2.5 mg/dL

- No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

- 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

Pulmonary:

- No severe lung disease

Other:

- 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior immunotherapy and recovered

- No concurrent immunomodulating agents

Chemotherapy:

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

Endocrine therapy:

- Concurrent corticosteroids allowed

Radiotherapy:

- At least 8 weeks since prior radiotherapy and recovered

Surgery:

- Recovered from any prior operative procedure

Other:

- No prior antineoplaston therapy

- Prior cytodifferentiating agent allowed

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor measurements at 12 weeks

Safety Issue:

No

Principal Investigator

Stanislaw R. Burzynski, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Burzynski Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000066483

NCT ID:

NCT00003452

Start Date:

May 1996

Completion Date:

Related Keywords:

  • Bladder Cancer
  • recurrent bladder cancer
  • stage IV bladder cancer
  • Urinary Bladder Neoplasms

Name

Location

Burzynski ClinicHouston, Texas  77055-6330