This trial is active, not recruiting.

Condition bladder cancer
Treatments antineoplaston a10, antineoplaston as2-1
Phase phase 2
Sponsor Burzynski Research Institute
Start date May 1996
End date August 2005
Trial size 40 participants
Trial identifier NCT00003452, BC-BL-2, CDR0000066483


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 or newly diagnosed stage IV bladder cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Tumor measurements at 12 weeks
time frame:

Secondary Outcomes

Survival at 1, 2, and 5 years from the start of treatment
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Bladder
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2008.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).