This trial is active, not recruiting.

Condition metastatic renal cell carcinoma
Treatment aldesleukin (proleukin)
Phase phase 2
Sponsor Beth Israel Deaconess Medical Center
Collaborator City of Hope National Medical Center
Start date November 2006
End date February 2015
Trial size 110 participants
Trial identifier NCT00554515, DFHCC 06-149, NCT00536757


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
High-dose IL-2
aldesleukin (proleukin)
Eligible patients will receive treatment with IL-2 alone following the FDA approved schedule. A treatment course consists of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 8-12 weeks of rest. A cycle is defined as 5 days of treatment. Patients will receive IL-2, 600,000 International Units/kg/dose (Chiron) intravenously (IV) every 8 (q8) hours for five days (maximum of 14 doses), beginning on day 1 and again on day 15.

Primary Outcomes

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
time frame: months

Secondary Outcomes

To determine 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 predictive features
time frame: months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

Official title 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
Principal investigator Kim Margolin, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.