Phase II Study of CAP-232 in Patients With Refractory Metastatic Renal Cell Carcinoma

Inclusion Criteria:

* Histologically confirmed stage IV kidney clear cell carcinoma.
* Confirmed progressive disease after receiving a previous systemic therapy, including at least one line of standard of care.
* Measurable disease
* Age \>18 years.
* Life expectancy of greater than 3 months.
* At least 5 years free of any other cancer(s). Basal cell carcinoma, provided that is neither infiltrating nor sclerosing and carcinoma in situ of the cervix, is acceptable.
* ECOG performance status 2 or lower (Karnofsky 60%).
* Normal organ and marrow function
* Adequate contraception prior to study entry and for the duration of study participation.
* Ability to understand and have the willingness to sign a written informed consent document.
* Ability to receive central vein access catheter and manage an infusion pump.
* Women of child bearing potential must have a negative serum pregnancy test.

Exclusion Criteria:

* Anti-cancer therapy within 4 weeks prior to entering the study
* Investigational agents less than 30 days prior to enrollment in the study.
* Known brain metastases
* History of allergic reactions attributed to compounds of similar composition to CAP-232.
* Past or current cancer other than kidney cancer, except for: Curatively treated non-melanoma skin cancer, In situ carcinoma of the cervix, Other cancer curatively treated and with no evidence of disease for at least 5 years
* Uncontrolled intercurrent illness /social situations that would limit compliance with study requirements.
* Breastfeeding
* Patients previously enrolled into this study and subsequently withdrawn