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.
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.
Condition or disease
Renal Cell Cancer MetastaticKidney Cancer Metastatic
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).
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).
Secondary Outcome Measures :
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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.