RIMMEL STUDY: Radiotherapy and ipilimumab in melanoma. Phase II clinical trial in patients with metastatic melanoma
- Conditions
- metastatic melanomaMedDRA version: 20.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-002058-11-IT
- Lead Sponsor
- CENTRO DI RIFERIMENTO ONCOLOGICO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 56
-Diagnosis of stage III-IV melanoma with indication to treatment with ipilimumab
- Two or more metastatic lesions measurable criteria mWHO immunocorrelati (24)
- Age> = 18
- Life expectancy >= 4 months
- ECOG 0-1
- Adequate bone marrow function (WBC> 3.0 x 10 ^ 3 / pL; N> 1.5 x 10 ^ 3 / pL; PLT> 100 x10 ^ 3 / pL; Hb> 10 g / dL)
- Adequate renal function (serum creatinine <= 1.5xUNL).
- Adequate hepatic function (Total bilirubin <= 1.5xUNL; AST-SGOT, SGPT ALT-<= 2.5xUNL; FAL and ¿GT <= 5xUNL)
- Written informed consent
- Geographical accessibility
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28
- Untreated brain metastases or progression phase
- Impediments logistics of the patient to participate in the study, and to afferire with regularity at the center participant (as regards the treatment part and the subsequent part of follow-up).
- Presence of clinically significant cardiovascular disease. For example: Cerebrovascular accident (within 1 year), acute coronary syndrome (within 1 year), unstable angina, symptomatic heart failure (New York Heart Association - NYHA) grade II or higher, cardiac arrhythmia applicant drug therapy.
-There is no known contraindications for each of the drugs used in the study (known hypersensitivity to the active substance, to lactose or to any of the excipients, hereditary fructose intolerance, peripheral sensory neuropathy with functional impairment, chronic inflammatory bowel disease and / or bowel obstruction , diverticulitis, patients in a state of malnutrition, patients with serious infections)
- Diagnosis of other malignancy with disease-free interval <5yrs from enrollment, with the exception of the squamous cell or basal and squamous skin, and cancer of the cervix in situ, breast cancer or bladder cancer.
- Presence of autoimmune diseases (excluding vitiligo)
- Previous treatment with antibody anti-CTLA-4
- Administration of vaccines up to 1 month before or after administration of ipilimumab
- Concomitant use of immunosuppressive drugs or use of systemic corticosteroids
- Presence of malabsorption, weight loss, active, diarrhea or grade = 2 seconds to NCI Common Toxicity Criteria vs. 4.03.
- Presence of residual toxicity from prior treatments symptomatic grade = 1 second NCI Common Toxicity Criteria vs. 4.03.
- Women who are pregnant or lactating.
- Women of childbearing age with positive pregnancy test or who refuse the test run (not considered fertile women with a history of amenorrhea for at least 12 months).
- Men and women of childbearing potential and sexually active who refuse or are unable to use contraceptive methods. They are accepted as methods of birth control during the duration of the study complete abstention or the use of two methods of birth control proven to be effective, one barrier (eg. Condoms) and one chemical (eg. Pill)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method