Radiotherapy as an immunological booster in patients with metastatic melanoma or renal cell carcinoma treated with High-dose Interleukin-2: evaluation of biomarkers of immunologic and therapeutic response - IL2HD

Overview

No summary available.

Registry

who.int

Start Date

July 23, 2012

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Patients, aged \= 18 years, with a diagnosis of histologically confirmed non resectable stage III or IV advanced melanoma or Renal Cell Carcinoma (RCC) 2\. Patients with a minimum of two lesions, one of which must be measurable 3\. At least one tumor lesion accessible for bioptic sampling. 4\. Prior lines (maximum 4\) of chemotherapy, immunotherapy or biological therapy for advanced disease are allowed (patients must have finished prior treatments at least 4 weeks before the first IL2 dose); 5\. Good performance status (ECOG performance status \=1 ) and adequate organ function: \- leukocytes \>3,500/microL \- absolute neutrophil count \>1,500/microL \- platelets \>100,000/microL \- total bilirubin within normal institutional limits \- AST(SGOT)/ALT(SGPT) \<2\.5 X ULN \- creatinine \<1,2 mg/dl \- hemoglobin \>9\.0 gm/dl \- ECG and echocardiogram within normal institutional limits \- pulmonary function tests within normal institutional limits (to be performed only in patients with lung metastases or history of impaired lung function) 6\. No contraindication for the use of vasopressor agents 7\. An estimated survival of at least 3 months.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 15
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 4

•1\. Patients with stage I or II melanoma or RCC 2\. Previous chemotherapy or radiotherapy or immunotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C). 3\. Current brain metastases 4\. History of allergic reactions attributed to IL2 or similar compounds 5\. Any autoimmune disease which could be exacerbated by IL\-2 6\. A medical illness requiring chronic treatments with corticosteroids or other immunosuppressive agents 7\. A history of significant cardiovascular disease, including myocardial infarction, congestive heart failure, primary cardiac arrhythmias, angina pectoris or cerebrovascular accident 8\. Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 9\. Other malignant neoplasia with a disease\-free interval of less than 5 years (except for previously treated basal cell carcinoma and in situ carcinoma of the uterine cervix) 10\. HIV\-positivity