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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 March 2013 |
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Main ID: |
NCT00582790 |
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Date of registration:
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19/12/2007 |
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Primary sponsor: |
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Public title:
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Study of IL2 in Combination With Zoledronic Acid in Patients With Kidney Cancer
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Scientific title:
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Phase II Study of Interleukin-2 in Combination With Zoledronic Acid in Patients With Untreated Metastatic Renal Cell Carcinoma |
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Date of first enrolment:
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August 2003 |
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Target sample size:
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12 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00582790 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Glenn Liu, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Wisconsin, Madison |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Kidney Cancer
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Intervention(s)
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Drug: IL2
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Drug: Zoledronic acid
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Number of Participants With Immunologic Responses
[Time Frame: baseline to cycle 2 day 8]
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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]
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Number of Participants With Toxicities
[Time Frame: Baseline to 30 days after last dose of study treatment]
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Secondary ID(s)
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CO03805
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HSC 2003-170
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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