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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00582790
Recruitment Status : Terminated (slow accrual)
First Posted : December 28, 2007
Results First Posted : March 19, 2013
Last Update Posted : November 25, 2019
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Kidney Cancer Drug: IL2 Drug: Zoledronic acid Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Interleukin-2 in Combination With Zoledronic Acid in Patients With Untreated Metastatic Renal Cell Carcinoma
Study Start Date : August 2003
Actual Primary Completion Date : August 2008
Actual Study Completion Date : September 2008

Arm Intervention/treatment
Experimental: 1
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.
Drug: IL2
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.
Other Name: Interleukin-2

Drug: Zoledronic acid
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.
Other Name: Zometa

Primary Outcome Measures :
  1. Number of Subjects With Antitumor Response With Low-dose Interleukin-2 in Combination With Zoledronic Acid [ Time Frame: CT scans obtained at baseline, then every 2 cycles ]
    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.

Secondary Outcome Measures :
  1. Number of Participants With Overall Survival and Progression-free Survival at 24 Weeks [ Time Frame: Time frame is from study entry until time to disease progression and time to death, up to 50 months ]
    All 12 patients were followed for survival until death. 8 participants who received more than one cycle of treatment and who were considered evaluable for response were followed until time to progression. Disease progression was determined by CT scans of the chest/abdomen/pelvis obtained every 2 cycles and based on RECIST version 1.0. Progression is defined using RECIST (V1.0) at least a 20% increase in the sum of the longest diameter (LD)of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

  2. Number of Participants With Toxicities [ Time Frame: Baseline to 30 days after last dose of study treatment ]
    Patients were observed for toxicities. The National Cancer Institute Common Terminology Criteria Version 2.0 was used to categorize and report adverse events.

  3. Number of Participants With Immunologic Responses [ Time Frame: baseline to cycle 2 day 8 ]
    Blood was collected to analyze T-cell populations from all patients prior to treatment on day 1 of cycles 1 and 2, and days 4 and 8 of cycles 1 and 2. Changes in gamma delta T-cell population and CD3 T-cell populations were reported.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00582790

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United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
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Principal Investigator: Glenn Liu, MD University of Wisconsin, Madison
Additional Information:
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Responsible Party: University of Wisconsin, Madison Identifier: NCT00582790    
Other Study ID Numbers: HSC 2003-170
A534260 ( Other Identifier: UW Madison )
SMPH/MEDICINE/MEDICINE*H ( Other Identifier: UW Madison )
First Posted: December 28, 2007    Key Record Dates
Results First Posted: March 19, 2013
Last Update Posted: November 25, 2019
Last Verified: March 2013
Keywords provided by University of Wisconsin, Madison:
Renal Cell Cancer
Additional relevant MeSH terms:
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Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Zoledronic Acid
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Bone Density Conservation Agents