Interleukin-2 in Metastatic 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: NCT01702909
Recruitment Status : Terminated (PI Decision)
First Posted : October 10, 2012
Results First Posted : September 27, 2017
Last Update Posted : February 8, 2018
Information provided by (Responsible Party):
Western Regional Medical Center

October 4, 2012
October 10, 2012
August 14, 2017
September 27, 2017
February 8, 2018
September 2012
December 2014   (Final data collection date for primary outcome measure)
Number of Participants With Response Using RECIST Criteria [ Time Frame: Measured until Disease Progression or death from any cause up to 2 year ]
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).
Progression free survival of patients with metastatic kidney cancer who have had disease progression on at least one prior therapy or who have not been treated. [ Time Frame: 9 weeks ]
Complete list of historical versions of study NCT01702909 on Archive Site
  • Median Duration of Response [ Time Frame: Measured from first response until Disease Progression or death from any cause up to 2 years ]
    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 [ Time Frame: measured from date of first dose until date of death ]
    from time of study entry until death
  • Response rate [ Time Frame: 9 weeks ]
  • Median duration of response [ Time Frame: 9 weeks ]
  • Median survival of patients treated with this moderate dose bolus Interleukin-2 schedule. [ Time Frame: 9 weeks ]
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Interleukin-2 in Metastatic Kidney Cancer
Phase II Trial of Moderate Dose Bolus Interleukin-2 in Metastatic Kidney Cancer
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.
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).
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Renal Cell Cancer Metastatic
  • Kidney Cancer Metastatic
Drug: Interleukin-2
Other Name: IL2
Experimental: Interleukin-2
Intervention: Drug: Interleukin-2
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2014
December 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients must have a histologic diagnosis of metastatic kidney cancer. Patients may have received prior systemic therapy or may be previously untreated
  2. Patients must have bi-dimensional measurable disease on physical exam or radiologic studies.
  3. ECOG performance status of 0 or 1 and estimated survival of at least 3 months.
  4. 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.
  5. 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.
  6. Patients with elevated temperatures > 100.5 F must have sources of occult infection excluded.
  7. Patients must be felt to have recovered from effects of prior therapy, such as > 2 weeks after prior chemotherapy.
  8. Patient consent must be obtained prior to entrance onto study.
  9. Women of childbearing potential must have a negative pregnancy test and must take adequate precautions to prevent pregnancy during treatment

Exclusion Criteria:

  1. Medical illness requiring corticosteroids or other immunosuppressive agents (such as cyclosporin or methotrexate.
  2. Autoimmune disease such as inflammatory arthritis which could be exacerbated by immune-based therapy.
  3. Prior history of psychiatric disorder which could be exacerbated by interleukin-2.
  4. Lactation or pregnancy.
  5. 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.
  6. Current brain metastasis.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Western Regional Medical Center
Western Regional Medical Center
Not Provided
Principal Investigator: Walter Quan, MD Western Regional Medical Center
Western Regional Medical Center
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP