Antineoplaston Therapy in Treating Patients With Stage IV Bladder Cancer - Article
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
RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.
|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
- 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.
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.
- 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
- 18 and over
- Karnofsky 60-100%
- At least 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
PRIOR CONCURRENT THERAPY:
- 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
- No prior antineoplaston therapy
- Prior cytodifferentiating agent allowed
Location and Contact Information
Burzynski Clinic, Houston, Texas, 77055-6330, United States; Recruiting
Stanislaw R. Burzynski, MD, PhD, Study Chair, Burzynski Research Institute
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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