Study of IL2 in Combination With Zoledronic Acid in Patients With Kidney Cancer
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Intervention: IL2; Zoledronic acid
Intervention description: Interleukin-2 will be given at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.; Zoledronic acid will be given on day 1 intravenously over 15 or 30 minutes starting at 400mcg. If no significant increase in gamma delta-T cell augmentation is seen, the dose of zoledronic acid will be increased in the subsequent cycle up to a maximum dose of 3mg.
Intervention MeSH terms: Zoledronic Acid; Interleukin-2
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Renal Cell Cancer; Metastatic

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.
    

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.