Clinical trial NCT00582790: Study of IL2 in Combination With Zoledronic Acid in Patients With Kidney Cancer
Official title: Phase II Study of Interleukin-2 in Combination With Zoledronic Acid in Patients With Untreated Metastatic Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Kidney Cancer
Keywords: Renal Cell Cancer
Metastatic
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2007-12-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Number of Subjects With Antitumor Response With Low-dose Interleukin-2 in Combination With Zoledronic Acid
timeFrame: CT scans obtained at baseline, then every 2 cycles
Secondary outcomes:
measure: Number of Participants With Overall Survival and Progression-free Survival at 24 Weeks
timeFrame: Time frame is from study entry until time to disease progression and time to death, up to 50 months
measure: Number of Participants With Toxicities
timeFrame: Baseline to 30 days after last dose of study treatment
measure: Number of Participants With Immunologic Responses
timeFrame: baseline to cycle 2 day 8
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Glenn Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: