Back to resultsInterleukin-2 in Metastatic Kidney Cancer
Primary Purpose
Renal Cell Cancer Metastatic, Kidney Cancer Metastatic
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Interleukin-2
Sponsored by
About this trial
This is an interventional treatment trial for Renal Cell Cancer Metastatic focused on measuring Metastatic Renal Cell, Metastatic Kidney Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients must have a histologic diagnosis of metastatic kidney cancer. Patients may have received prior systemic therapy or may be previously untreated
- Patients must have bi-dimensional measurable disease on physical exam or radiologic studies.
- ECOG performance status of 0 or 1 and estimated survival of at least 3 months.
- White blood count of > 3500/mm3, platelet count > 100,000/mm3, hemoglobin > 9.0 gm/dl; bilirubin, ALT, AST < 3 x upper limit of normal; serum creatinine < 2.0 mg/dl.
- Patients must undergo a low-level cardiac stress test as a screen for possible atherosclerotic heart disease. Patients with a positive stress test would be excluded from this trial.
- Patients with elevated temperatures > 100.5 F must have sources of occult infection excluded.
- Patients must be felt to have recovered from effects of prior therapy, such as > 2 weeks after prior chemotherapy.
- Patient consent must be obtained prior to entrance onto study.
- Women of childbearing potential must have a negative pregnancy test and must take adequate precautions to prevent pregnancy during treatment
Exclusion Criteria:
- Medical illness requiring corticosteroids or other immunosuppressive agents (such as cyclosporin or methotrexate.
- Autoimmune disease such as inflammatory arthritis which could be exacerbated by immune-based therapy.
- Prior history of psychiatric disorder which could be exacerbated by interleukin-2.
- Lactation or pregnancy.
- Evidence of significant cardiovascular disease including history of recent (< 6 months prior) myocardial infarction, congestive heart failure, primary cardiac arrhythmias (not due to electrolyte disorder or drug toxicity, for example) beyond occasional PVC's, angina, positive low-level stress test, or cerebrovascular accident.
- Current brain metastasis.
Sites / Locations
- Western Regional Medical Center, Inc
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interleukin-2
Arm Description
Interleukin-2
Outcomes
Primary Outcome Measures
Number of Participants With Response Using RECIST Criteria
Radiographic studies to evaluate for response were done after every 2 cycles (6 weeks) until disease progression or death from any cause up to 2 years. Standard RECIST response criteria were utilized. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = 100%(CR + PR/total number of patients receiving Interleukin-2).
Secondary Outcome Measures
Median Duration of Response
Duration of response is calculated as the time (months) from the date at which response is first observed (per standard Response Evaluation Criteria In Solid Tumors [RECIST] to the date of first observed disease progression or date of death from any cause, whichever came first, assessed up to 2 years. The actual date of tumor assessments was used for this calculation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.
Median Survival
from time of study entry until death
Full Information
NCT ID
NCT01702909
First Posted
October 4, 2012
Last Updated
February 6, 2018
Sponsor
Western Regional Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01702909
Brief Title
Interleukin-2 in Metastatic Kidney Cancer
Official Title
Phase II Trial of Moderate Dose Bolus Interleukin-2 in Metastatic Kidney Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
PI Decision
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western Regional Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether Interleukin-2 at the dose and schedule used in this study will help increase tumor shrinkage.
Detailed Description
In this phase II study, the IL-2 schedule (daily IL-2 for 5 days (per week) every 3 weeks) will be tested in a cohort of kidney cancer patients to attempt to determine the response rate, median duration of response, and median survival. The dose intensity of this schedule would allow a patient treated on this regimen to achieve the target threshold (> 1440 million IU/m2/year).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Cancer Metastatic, Kidney Cancer Metastatic
Keywords
Metastatic Renal Cell, Metastatic Kidney Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interleukin-2
Arm Type
Experimental
Arm Description
Interleukin-2
Intervention Type
Drug
Intervention Name(s)
Interleukin-2
Other Intervention Name(s)
IL2
Intervention Description
Interleukin-2
Primary Outcome Measure Information:
Title
Number of Participants With Response Using RECIST Criteria
Description
Radiographic studies to evaluate for response were done after every 2 cycles (6 weeks) until disease progression or death from any cause up to 2 years. Standard RECIST response criteria were utilized. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = 100%(CR + PR/total number of patients receiving Interleukin-2).
Time Frame
Measured until Disease Progression or death from any cause up to 2 year
Secondary Outcome Measure Information:
Title
Median Duration of Response
Description
Duration of response is calculated as the time (months) from the date at which response is first observed (per standard Response Evaluation Criteria In Solid Tumors [RECIST] to the date of first observed disease progression or date of death from any cause, whichever came first, assessed up to 2 years. The actual date of tumor assessments was used for this calculation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.
Time Frame
Measured from first response until Disease Progression or death from any cause up to 2 years
Title
Median Survival
Description
from time of study entry until death
Time Frame
measured from date of first dose until date of death
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have a histologic diagnosis of metastatic kidney cancer. Patients may have received prior systemic therapy or may be previously untreated
Patients must have bi-dimensional measurable disease on physical exam or radiologic studies.
ECOG performance status of 0 or 1 and estimated survival of at least 3 months.
White blood count of > 3500/mm3, platelet count > 100,000/mm3, hemoglobin > 9.0 gm/dl; bilirubin, ALT, AST < 3 x upper limit of normal; serum creatinine < 2.0 mg/dl.
Patients must undergo a low-level cardiac stress test as a screen for possible atherosclerotic heart disease. Patients with a positive stress test would be excluded from this trial.
Patients with elevated temperatures > 100.5 F must have sources of occult infection excluded.
Patients must be felt to have recovered from effects of prior therapy, such as > 2 weeks after prior chemotherapy.
Patient consent must be obtained prior to entrance onto study.
Women of childbearing potential must have a negative pregnancy test and must take adequate precautions to prevent pregnancy during treatment
Exclusion Criteria:
Medical illness requiring corticosteroids or other immunosuppressive agents (such as cyclosporin or methotrexate.
Autoimmune disease such as inflammatory arthritis which could be exacerbated by immune-based therapy.
Prior history of psychiatric disorder which could be exacerbated by interleukin-2.
Lactation or pregnancy.
Evidence of significant cardiovascular disease including history of recent (< 6 months prior) myocardial infarction, congestive heart failure, primary cardiac arrhythmias (not due to electrolyte disorder or drug toxicity, for example) beyond occasional PVC's, angina, positive low-level stress test, or cerebrovascular accident.
Current brain metastasis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Quan, MD
Organizational Affiliation
Western Regional Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Regional Medical Center, Inc
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85338
Country
United States
12. IPD Sharing Statement
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Interleukin-2 in Metastatic Kidney Cancer
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