Arginine in Treating Patients With Anti-VEGF Induced Kidney Injury

L-Arginine For Anti-VEGF Induced Kidney Injury

This phase II trial studies how well arginine works in treating patients with kidney injury caused by anti-VEGF drugs used in standard treatment for cancer. Arginine is a nutritional supplement that may control side effects of anti-cancer drugs such as high blood pressure and protein in the urine and may also help to improve kidney function in patients.

PRIMARY OBJECTIVES:

I. To assess the value and/or limitations of using orally supplemented arginine (L-arginine) to improve renal function associated with the use of anti-angiogenic therapies that target vascular endothelial growth factor (VEGF).

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive arginine orally (PO) four times daily (QID). Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity.

GROUP II: Patience receive placebo PO QID. Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment patients are followed up within 1 month.

Inclusion Criteria:

• On or enrolled for anti-VEGF therapy
• Systolic Blood Pressure >= 140 mm Hg
• Diastolic Blood Pressure >= 90 mm Hg
• Proteinuria >= 500 mg/day or worsening glomerular filtration rate (GFR) (> 0.3 mg/dl in 48 hours [hrs.] or > 50% decline from baseline creatinine in 1 week)

Exclusion Criteria:

• Allergy to L-arginine
• Systolic Blood Pressure < 140 mm Hg
• Diastolic Blood Pressure < 90 mm Hg
• Proteinuria < 500 mg/day
• Continuous tube feeds (since the medication will be given in-between meals)