Interleukin-2 in Metastatic Melanoma

Study Overview
=================
Brief Summary
-----------------
To determine whether Interleukin-2 at the dose and schedule will help to increase tumor shrinkage

Detailed Description
-----------------
In this phase II trial, the previously described IL-2 schedule (daily IL-2 for 5 days (per week) every 3 weeks) will be tested in a larger cohort of patients with melanoma 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).

Official Title
-----------------
Phase II Trial of Moderate Dose Bolus Interleukin-2 in Metastatic Melanoma

Conditions
-----------------
Melanoma Metastatic

Intervention / Treatment
-----------------
* Drug: Interleukin-2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have a histologic diagnosis of metastatic melanoma. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interleukin-2<br>Interleukin-2 will be used in this group | Drug: Interleukin-2<br>* Interleukin-2<br>* Other names: IL2;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate | 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). | Measured until Disease Progression or death from any cause up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Measured until Disease Progression or death from any cause up to 2 years | 
| Median Survival | Measured from date of entry on study until date of death | From time of study entry until death, up to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic Melanoma