Carcinoma, Renal Cell, Kidney Neoplasms, Urogenital Neoplasms, Urologic Neoplasms
Conditions
Keywords
Kidney cancer, Renal cell carcinoma, Motexafin gadolinium
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).
Interventions
DRUGmotexafin gadolinium
Sponsors
Pharmacyclics LLC.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response rate (CP, PR) to MGd in patients with confirmed progressive RCC (renal cell carcinoma) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed