A Phase II Study of EC17 (Folate-hapten Conjugate) in Patients With Progressive Metastatic Renal Cell Carcinoma

Inclusion Criteria:

• Must have a histologically confirmed diagnosis of renal cell carcinoma (clear cell orpredominately clear cell component). Papillary histology may also be enrolled (maximumof 6 patients)

• Must be diagnosed with relapsed or Stage IV disease that is medically or surgicallyunresectable and that has progressed after systemic therapy, including at least oneagent in the general class of kinase inhibitors (TKI not required for papillaryhistology)

• Must have measurable/evaluable metastatic disease sites that have not previouslyreceived radiotherapy and which does not require palliative intervention (at the timeof enrollment). Patients with non-measurable/evaluable disease are ineligible

• Must have at least one tumor lesion that displays uptake of 99mTc-EC20

• Must be > than or = 18 years of age

• Women must either be 1)not of child-bearing potential of 2)have a negative serumpregnancy test within 7 days prior to commencing treatment with investigational agents

• Must have completed prior cytotoxic chemotherapy, radiotherapy, immunotherapy orexperimental therapy 30 or more days prior to study enrollment, and recovered (orreturned to baseline) from associated acute toxicities. This restriction excludespalliative radiotherapy.

• Must have an ECOG score less than or equal to 2

• Must have adequate hematologic, renal, and heptic function

Exclusion Criteria:

• Must not have a history of severe hypersensitivity (grade 3 - 4 allergic reaction) tofluorescein, radiological contrast agent, cytokines, or have received fluoresceinwithin 30 days of the study

• Must not have medical conditions that preclude the use of IL-2 or IFN-α.

• Must not be pregnant or breast-feeding

• Must not be currently undergoing chemotherapy, anticancer hormonal therapy, and/ortherapy with immunosuppressant agents

• Must not be currently receiving bisphosphonates such as Zometa® (unless started > fourweeks prior to treatment with EC90/GPI-0100, in which case they can be continued)

• Must not have any concomitant malignancy with the exception of basal cell or squamouscell carcinoma of skin

• Must not have radiographically documented evidence of current brain metastases, ahistory of stem cell transplant, immunodeficiency, and/or a medical or psychiatricillness (that in the investigator's opinion, would prevent adequate compliance withstudy therapy or evaluation of the endpoints)

• Must not have been administered another radiopharmaceutical that would interfere withthe assessment of 99mTc-EC20

• Must not be unable to tolerate conditions for radionuclide imaging