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.

Condition	Intervention	Phase
Carcinoma, Renal Cell Urogenital Neoplasms Urologic Neoplasm Kidney Neoplasms	Drug: motexafin gadolinium	Phase II

Further Study Details: 

Primary Outcomes: Clinical response rate (CP, PR) to MGd in patients with confirmed progressive RCC
Secondary Outcomes: Clinical benefit rate (CR, PR, SD); Time to progression; Progression-free survival; Overall survival and survival at 6 and 12 months; Duration of clinical response
Expected Total Enrollment:  43

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• ≥ 18 years old
• Histologically confirmed Renal Cell Carcinoma with clinically or pathologically confirmed progression
• Ineligible for 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

and

• Evidence of central nervous system metastases within past year
• Uncontrolled hypertension
• Known history of porphyria, G6PD deficiency or HIV

Please refer to this study by ClinicalTrials.gov identifier  NCT00134186

France Bui, MD      877.676.0330    fbui@pcyc.com
Cindy Cheng, PharmD      877.676.0330    ccheng@pcyc.com

Texas
      Methodist Hospital, Houston,  Texas,  77030,  United States; Recruiting

Study chairs or principal investigators

Robert J Amato, D.O.,  Principal Investigator,  Methodist Hospital Genitourinary Oncology   

Study ID Numbers:  PCYC-0219
Last Updated:  August 23, 2005
Record first received:  August 22, 2005
ClinicalTrials.gov Identifier:  NCT00134186
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30