Status:
COMPLETED
Radiotherapy As an Immunological Booster in Patients with Metastatic Melanoma or Renal Cell Carcinoma Treated with High-dose Interleukin-2
Lead Sponsor:
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Conditions:
Metastatic Renal Cell Cancer
Malignant Melanoma, Metastatic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Title: 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 therapeut...
Detailed Description
Title: 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 therapeut...
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically confirmed non resectable stage III or IV advanced melanoma or Renal Cell Carcinoma (RCC).
- 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).
- At least one tumor lesion accessible for bioptic sampling.
- 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 dose);
- Male or Female, aged \>= 18 years.
- Life expectancy of greater than 3 months.
- ECOG performance status \<=1
- 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)
- no contraindication for the use of vasopressor agents
- 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
- Participant is willing and able to give informed consent for participation in the study.
Exclusion
- Patient with stage I or II melanoma or RCC
- 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 earlier.
- Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
- 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 events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to IL-2 or other agents used in the study.
- Any autoimmune disease which could be exacerbated by IL-2
- A medical illness requiring chronic treatments with corticosteroids or other immunosuppressive agents
- A history of significant cardiovascular disease, including myocardial infarction, congestive heart failure, primary cardiac arrhythmias, angina pectoris or cerebrovascular accident
- 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 study requirements.
- 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);
- HIV-positivity, whether or not symptomatic.
Key Trial Info
Start Date :
July 9 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2025
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01884961
Start Date
July 9 2012
End Date
January 1 2025
Last Update
January 13 2025
Active Locations (1)
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1
UO Oncologia Medica, IRCCS IRST
Meldola (FC), FC, Italy, 47014