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 benefit. This trial is being conducted at 14 treatment centers in the Untied States that
specialize in giving IL-2. All patients who are eligible for enrollment in the study will
receive the FDA approved regimen of high-dose IL-2. To identify markers that may predict
response to IL-2, patients are asked to provide a piece of their original tumor for
research. They are not required to have a separate tumor biopsy. Blood samples (2-3
tablespoons) for research will also be drawn prior to treatment and tumor measurements will
be obtained before and after treatment.
- Patients must have histologically confirmed renal cell carcinoma that is metastatic
- 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