Study of Motexafin Gadolinium for the Treatment of Renal Cell (Kidney) Cancer

Phase II Trial of Motexafin Gadolinium for Treatment of Metastatic Renal Cell Carcinoma

The purpose of this study is to find out if renal cell (kidney) cancer that has spread to other parts of the body will respond to treatment with motexafin gadolinium (MGd).

Inclusion Criteria:

• ≥ 18 years old
• Histologically confirmed renal cell carcinoma with clinically or pathologically confirmed progression
• Ineligible for interleukin-2 (IL-2) treatment and/or have had 2 or fewer prior treatments
• Measurable disease
• Hemoglobin ≥ 9 mg/dL
• ECOG performance status of 0, 1, or 2
• Willing and able to provide written informed consent

Exclusion Criteria:

• Inadequate bone marrow, renal and liver function by laboratory criteria

  • Absolute neutrophil count < 1500/µL;
  • Platelet count < 100,000/µL;
  • AST or ALT > 2 x upper limit of normal (ULN);
  • Alkaline phosphatase > 5 x ULN;
  • Total bilirubin > 2 x ULN;
  • Creatinine > 2.0 mg/dL.

• Evidence of central nervous system metastases within past year

• Uncontrolled hypertension

• Known history of porphyria, G6PD deficiency or HIV