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

University of Wisconsin (UW)

Status and phase: Terminated; Phase 2

Conditions: Kidney Cancer

Treatments: Drug: IL2; Drug: Zoledronic acid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00582790

HSC 2003-170

CO03805

SMPH/MEDICINE/MEDICINE*H (Other Identifier)

A534260 (Other Identifier)

Details and patient eligibility

About

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.

Full description

The purpose of this research is to evaluate the antitumor response of low-dose Interleukin-2 in combination with Zoledronic acid on subjects with previously untreated, unresectable metastatic renal cell carcinoma. Also, the study will assess the tolerability, safety, pharmacodynamic effects, and immunologic effects of low-dose Interleukin-2 in combination with Zoledronic acid on angiogenesis inhibition and anti-metastatic potential by measuring serum/plasma angiogenic/metastatic factor levels and by quantitating changes in cytokine expression, antigen-specific T-cell immune responses, and peripheral gd T-cell frequency and function.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

1

Experimental group

Description:

Interleukin-2 subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles in combination with Zoledronic acid IV on day 1 of every 4 week (28 days) cycle.

Treatment:

Drug: Zoledronic acid

Drug: IL2