Antineoplaston Therapy in Treating Patients With Stage IV Kidney Cancer
This trial is active, not recruiting.
|Conditions||kidney cancer, transitional cell cancer of the renal pelvis and ureter|
|Treatments||antineoplaston a10, antineoplaston as2-1|
|Sponsor||Burzynski Research Institute|
|Start date||August 1998|
|Trial size||40 participants|
|Trial identifier||NCT00003520, BC-RN-2, CDR0000066564|
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 studies the effectiveness of antineoplaston therapy in treating patients who have stage IV kidney cancer.
Male or female participants at least 18 years old.
DISEASE CHARACTERISTICS: - Histologically confirmed stage IV adenocarcinoma or transitional cell carcinoma of the kidney that is unlikely to respond to existing therapy - Measurable disease by MRI or CT scan - Tumor must be more than 2 cm for lymph nodes in head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm for other locations 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: - No hepatic insufficiency - Bilirubin no greater than 2.5 mg/dL - SGOT and SGPT no greater than 5 times upper limit of normal Renal: - No renal insufficiency - Creatinine no greater than 2.5 mg/mL - No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: - No known chronic heart failure - 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, such as chronic obstructive pulmonary disease Other: - Not pregnant or nursing - Fertile patients must use effective contraception during and for 4 weeks after study participation - Not a high medical or psychiatric risk - No concurrent nonmalignant systemic disease that would preclude therapy - No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy - No concurrent immunomodulatory agents Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered - No concurrent antineoplastic agents Endocrine therapy: - Concurrent corticosteroids allowed Radiotherapy: - At least 8 weeks since prior radiotherapy and recovered Surgery: - Recovered from prior surgery Other: - Prior cytodifferentiating agents allowed - No prior antineoplastons
|Official title||Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Kidney|
|Description||OBJECTIVES: - Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with incurable carcinoma of the kidney. - 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 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 achieving CR. Tumors are measured every 2 months for 1 year and every 3 months for 1 year. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.|
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