The High-Dose Aldesleukin (IL-2) "Select" Trial for Patients With Metastatic Renal Cell Carcinoma

• Status: Completed
• Trial end date: 2013-10-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: City of Hope National Medical Center; Dartmouth-Hitchcock Medical Center; Indiana University; Loyola University; Our Lady of Mercy Medical Center; Providence Cancer Center, Earle A. Chiles Research Institute; Roswell Park Cancer Institute; University of California, Los Angeles; University of Cincinnati; University of Pittsburgh; University of Virginia; Vanderbilt University; Vanderbilt University Medical Center; Wayne State University
• Treatments: Aldesleukin; Interleukin-2

Criteria

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.