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.|
|ClinicalTrials.gov Identifier: NCT00582790|
Recruitment Status : Terminated (slow accrual)
First Posted : December 28, 2007
Results First Posted : March 19, 2013
Last Update Posted : March 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Drug: IL2 Drug: Zoledronic acid||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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
- 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.
- 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
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT00582790
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Glenn Liu, MD||University of Wisconsin, Madison|