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

Pharmacyclics

Status and phase

Completed

Phase 2

Conditions

Carcinoma, Renal Cell

Urogenital Neoplasms

Kidney Neoplasms

Urologic Neoplasms

Treatments

Drug: motexafin gadolinium

Study type

Interventional

Funder types

Industry

Identifiers

NCT00134186

PCYC-0219

Details and patient eligibility

About

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).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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