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.

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.

• Kidney Cancer
• Transitional Cell Cancer of the Renal Pelvis and Ureter

• Drug: antineoplaston A10
• Drug: antineoplaston AS2-1

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