High-dose interleukin 2 (Proleukin, Novartis) (IL-2) is approved by the U.S Food and Drug
Administration (FDA) for the treatment of metastatic kidney cancer and is a standard
treatment of this disease. At the present time, IL-2 is the only therapy for kidney cancer
that can produce a remission of disease that lasts after treatment is completed. However,
most patients who receive IL-2 do not benefit and all patients experience potentially
dangerous side effects.
Recent research has suggested that certain patients may respond better to IL-2 than others.
The Cytokine Working Group is currently conducting a clinical trial that aims to identify and
confirm this research and narrow the application of IL-2 to those patients most likely to
- To determine, in a prospective fashion, if the response rate to high-dose IL-2 for
patients with metastatic renal cell carcinoma and "good" pathologic predictive features
is significantly higher than a historical, unselected patient population.
- To determine, in a prospective fashion, the response rate to high-dose IL-2 for patients
with metastatic renal cell carcinoma and "poor" pathologic predictive features and to
compare this response rate to the response rate of patients with "good" pathologic
- To determine if components of other predictive and prognostic models (e.g MSKCI or UCLA
criteria) can help to further define the optimal population to receive high-dose IL2 for
metastatic renal cell carcinoma.
- To identify features of the baseline immune function (arginine, arginase, T cell zeta
chain) of patients with metastatic renal cell carcinoma that are associated with
response to high-dose IL-2.
- To identify new proteins or patterns of gene expression that might be associated with
high-dose IL-2 responsiveness in order to further narrow the application of IL-2 therapy
to those who will benefit the most.
- Patients must have histologically confirmed renal cell carcinoma that is metastatic or
- 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.
- 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
- 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