Study of IL2 in Combination With Zoledronic Acid in Patients With Kidney Cancer

• Status: Terminated
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is being done to see if we can improve the response of Interleukin-2 by adding Zoledronic acid. The effectiveness of the combination of drugs in kidney cancer is unknown and will be investigated in this study. In particular, this study will evaluate the effect of this combination on kidney cancer and will also examine the safety and side effects of IL-2 with Zoledronic acid.

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

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborator: Novartis
• Treatments: Diphosphonates; Interleukin-2; Zoledronic Acid

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed renal cell carcinoma with metastasis.

• Must have measurable disease.

• No prior cytokine, chemotherapy, hormonal, or other immuno-based therapies (including vaccine or cellular based) for their renal cancer is allowed. No prior use of bisphosphonates will be allowed. One prior experimental therapy will be permitted as long as > 4 weeks have passed since last drug administration.

• ECOG performance status 0 or 1

• Adequate cardiac function by history.

• Pulse-oximetry > 92% on room air.

Exclusion Criteria:

• Radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.

• Known brain metastases

• Any history of an autoimmune disease (ie. psoriasis, inflammatory bowel disease, etc) must receive clearance by the investigator before being permitted on study due to the potential worsening of those disorders from IL-

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.

• History of myocardial infarction or hospitalization for congestive heart failure within 12 months of enrollment.

• History of prior malignancy (except basal cell carcinoma resected with curative intent) unless resected or treated with curative intent and disease free for > 5 years.

• Any history of seizures given increased seizure risk with IL-2.

• Organ allograft (transplant) recipients will be excluded given absolute contraindication with IL-2 therapy.

• Pregnant women are excluded

• Patients on systemic steroids (oral or IV) will not be eligible for the study.