Study of Motexafin Gadolinium for the Treatment of Renal Cell (Kidney) Cancer
Phase 2
Completed
- Conditions
- Carcinoma, Renal CellUrogenital NeoplasmsUrologic NeoplasmsKidney Neoplasms
- Registration Number
- NCT00134186
- Lead Sponsor
- Pharmacyclics LLC.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Clinical response rate (CP, PR) to MGd in patients with confirmed progressive RCC (renal cell carcinoma)
- Secondary Outcome Measures
Name Time Method Clinical benefit rate (complete response [CR], partial response [PR], stable disease [SD]) Time to progression Progression-free survival Overall survival and survival at 6 and 12 months Duration of clinical response
Trial Locations
- Locations (1)
Methodist Hospital
🇺🇸Houston, Texas, United States