Clinical Trial: Antineoplaston Therapy in Treating Patients With Stage IV Bladder Cancer

This study is currently recruiting patients.
Verified by National Cancer Institute (NCI) July 2004

Sponsored by: Burzynski Research Institute
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003452

Purpose

RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.

PURPOSE: This phase II trial is studying how well antineoplaston therapy work in treating patients with stage IV bladder cancer.

Condition Intervention Phase
Recurrent Bladder Cancer
Stage IV Bladder Cancer
 Drug: antineoplaston A10
 Drug: antineoplaston AS2-1
 Procedure: alternative product therapy
 Procedure: biological response modifier therapy
 Procedure: biologically based therapies
 Procedure: cancer prevention intervention
 Procedure: complementary and alternative therapy
 Procedure: differentiation therapy
Phase II

MedlinePlus related topics:  Bladder Cancer
Genetics Home Reference related topics:  bladder cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Stage IV Bladder Carcinoma

Further study details as provided by National Cancer Institute (NCI):

OBJECTIVES:

  • Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with stage IV 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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage IV bladder carcinoma that is unlikely to respond to existing therapy and for which no curative therapy exists
  • 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:

Surgery:

  • Recovered from any prior operative procedure

Other:

  • No prior antineoplaston therapy
  • Prior cytodifferentiating agent allowed

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00003452


Texas
      Burzynski Clinic, Houston,  Texas,  77055-6330,  United States; Recruiting
Stanislaw R. Burzynski, MD, PhD  713-335-5697    info@burzynskiclinic.com 

Study chairs or principal investigators

Stanislaw R. Burzynski, MD, PhD,  Study Chair,  Burzynski Research Institute   

More Information

Clinical trial summary from the National Cancer Institute''''s PDQ® database

Study ID Numbers:  CDR0000066483; BC-BL-2
Last Updated:  December 8, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003452
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10



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