Status:
COMPLETED
Study of Motexafin Gadolinium for the Treatment of Renal Cell (Kidney) Cancer
Lead Sponsor:
Pharmacyclics LLC.
Conditions:
Carcinoma, Renal Cell
Urogenital Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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).
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00134186
Last Update
March 5 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Methodist Hospital
Houston, Texas, United States, 77030