Antineoplaston Therapy in Treating Patients With Stage IV Kidney Cancer
Antineoplaston Therapy in Treating Patients With Stage IV Kidney Cancer
Current therapies for Stage IV Kidney Cancer provide very limited benefit to the patient. The
 anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the
 treatment of Stage IV Kidney Cancer.

 PURPOSE: This study is being performed to determine the effects (good and bad) that
 Antineoplaston therapy has on patients with Stage IV Kidney Cancer.
OVERVIEW: This is a single arm, open-label study in which patients with Stage IV Kidney
 Cancer receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal +
 Astugenal) until the maximum tolerated dose is reached. Treatment continues up to12 months in
 the absence of disease progression or unacceptable toxicity.

 OBJECTIVE S:

 -  To determine the efficacy of Antineoplaston therapy in patients with Stage IV Kidney
 Cancer, as measured by an objective response to therapy (complete response, partial
 response or stable disease).

 -  To determine the safety and tolerance of Antineoplaston therapy in patients with Stage
 IV Kidney Cancer.

 -  To determine objective response, tumor size is measured utilizing MRI scans, which are
 performed every 8 weeks for the first two years, every 3 months for the third and fourth
 years, every 6 months for the 5th and sixth years, and annually thereafter.
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