The High-Dose Aldesleukin (IL-2) "Select" Trial: A Trial Designed to Prospectively Validate Predictive Models of Response to High Dose IL-2 Treatment in Patients With Metastatic Renal Cell Carcinoma

Inclusion Criteria:

- Patients must have histologically confirmed renal cell carcinoma that is metastatic
or unresectable.

- If patients have measurable disease restricted to a solitary lesion, its neoplastic
nature should be confirmed by cytology/histology.

- Patients must provide access to tissue blocks containing adequate tumor for
interpretation and analysis.

- Patients must have measurable disease.

- Patients must have good performance status (ECOG 0 or 1; Karnofsky PS 100-80%).

- Patients must have adequate organ function.

- Patients must have no contraindication of vasopressor agents.

- Patients must be ≥ 18 years of age.

Exclusion Criteria:

- Patients who have received systemic therapy for metastatic disease.

- Patients with organ allografts.

- Patients who require or are likely to require systemic corticosteroid therapy for
intercurrent illness.

- Patients with any significant medical disease other than the malignancy (e.g. COPD,
patients with ascites or pleural effusions), which in the opinion of the investigator
would significantly increase the risk of immunotherapy.

- Patients with a history of another malignancy within the past 5 years other than
surgically cured non-melanoma skin cancer, carcinoma-in-situ or Stage I carcinoma of
the cervix.