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
1. Patients must have histologically or cytologically confirmed non resectable stage III
or IV advanced melanoma or Renal Cell Carcinoma (RCC).
2. Patients must have a minimum of two lesions and one of which must be measurable, (it
can be accurately measured in at least one dimension (longest diameter to be
recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan).
3. At least one tumor lesion accessible for bioptic sampling.
4. Prior lines (maximum 4) of chemotherapy, immunotherapy or biological therapy (e.g.
inhibitors of B-Raf or c-Kit, Ipilimumab, etc.) for advanced disease are allowed
(patients must have finished prior treatments at least 4 weeks before the first IL2
5. Male or Female, aged >= 18 years.
6. Life expectancy of greater than 3 months.
7. ECOG performance status <=1
8. Patients must have normal organ and marrow function as defined below:
- 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 institutional upper limit of normal
- creatinine < 1,2 mg/dl
- haemoglobin > 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)
9. no contraindication for the use of vasopressor agents
10. Female participants of child bearing potential and male participants whose partner is
of child bearing potential must be willing to ensure that they or their partner use
effective contraception during the study and for 3 months thereafter
11. Participant is willing and able to give informed consent for participation in the
1. Patient with stage I or II melanoma or RCC
2. Patients who have had chemotherapy or radiotherapy or immunotherapy within 4 weeks (6
weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have
not recovered from adverse events due to agents administered more than 4 weeks
3. Participation in another clinical trial with any investigational agents within 30
days prior to study screening.
4. Patients with known brain metastases should be excluded from this clinical trial
because of their poor prognosis and because they often develop progressive neurologic
dysfunction that would confound the evaluation of neurologic and other adverse
5. History of allergic reactions attributed to compounds of similar chemical or biologic
composition to IL-2 or other agents used in the study.
6. Any autoimmune disease which could be exacerbated by IL-2
7. A medical illness requiring chronic treatments with corticosteroids or other
8. A history of significant cardiovascular disease, including myocardial infarction,
congestive heart failure, primary cardiac arrhythmias, angina pectoris or
9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
10. Other known malignant neoplastic diseases in the patient's medical history 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);
11. HIV-positivity, whether or not symptomatic.