Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-24 @ 1:04 PM
NCT ID:
NCT01884961
Eligibility Criteria:
Inclusion Criteria:
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 dose);
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 study.
Exclusion Criteria:
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 earlier.
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 events.
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 immunosuppressive agents
8. A history of significant cardiovascular disease, including myocardial infarction, congestive heart failure, primary cardiac arrhythmias, angina pectoris or cerebrovascular accident
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 study requirements.
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01884961
Study Brief:
Protocol Section:
NCT01884961