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Phase II Study of Interleukin-2 in Combination With Zoledronic Acid in Patients With Untreated Metastatic Renal Cell Carcinoma

Phase 2
18 Years
Not Enrolling
Kidney Cancer

Thank you

Trial Information

Phase II Study of Interleukin-2 in Combination With Zoledronic Acid in Patients With Untreated Metastatic Renal Cell Carcinoma

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

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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Subjects With Antitumor Response With Low-dose Interleukin-2 in Combination With Zoledronic Acid

Outcome Description:

Anti-tumor response was measured per RECIST criteria (V1.0) and assessed by chest/abdomen/pelvis CT: Complete Response (CR), disappearance of all target lessions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Response (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started.

Outcome Time Frame:

CT scans obtained at baseline, then every 2 cycles

Safety Issue:


Principal Investigator

Glenn Liu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison


United States: Institutional Review Board

Study ID:

HSC 2003-170



Start Date:

August 2003

Completion Date:

September 2008

Related Keywords:

  • Kidney Cancer
  • Renal Cell Cancer
  • Metastatic
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



University of WisconsinMadison,, Wisconsin  53792-5666