metastatic melanoma or renal cell carcinoma MedDRA version: 14.1 Level: PT Classification code 10038414 Term: Renal cell carcinoma stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10025671 Term: Malignant melanoma stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10025670 Term:
Conditions
Interventions
Trade Name: PROLEUKIN*EV 1F 18MUI
Pharmaceutical Form: Injection
INN or Proposed INN: ALDESLEUKIN
CAS Number: 110942-02-4
Concentration unit: million IU million international units
Concentration type:
Sponsors
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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) 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. to determine the tumor antigen-specific immune response induced by the treatment 2. to prospectively determine the predictive/prognostic value of pretreatment biological features in identifying patients who will benefit from HDIL-2-based therapy;Secondary Objective: 1. Toxicity 2. Response Rate 3. Overall Survival.;Primary end point(s): 1) immunological efficacy, as assessed by quantification of circulating immune effectors specific for a selected panel of tumor antigens. 2) predictive value of pretreatment serum biomarkers in identifying patients who will benefit from high dose IL-2 based therapy.;Timepoint(s) of evaluation of this end point: 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints will be toxicity, the response rate (RR) and the overall survival (OS).;Timepoint(s) of evaluation of this end point: 36 months | — |
Countries
Italy
Contacts
Public Contactdata manager
IRST
Outcome results
None listed