patients with advanced Kaposi sarcoma, stage III/IV MedDRA version: 9.1 Level: LLT Classification code 10023287 Term: Kaposi's sarcoma classical
Conditions
Interventions
Trade Name: CRIXIVAN
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Indinavir
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 800-
Trade Name: BLEOMICINA
Sponsors
ISTITUTO SUPERIORE DI SANITA`
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects enrolled in this study must: - have a documented diagnosis of KS; - be HIV-negative as proven by approved test [enzyme-linked immunosorbent assay (ELISA) antibody at screening]; - be classified as a stage III or IV; - be 18 years old; - have stopped every other anti-KS therapy since at least 2 weeks; - be informed of the nature of the study and have provided written informed consent. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any one or more of the following are cause for exclusion from the study: - inability to give informed consent; - other concomitant illness, neoplasia, with the exception of small non-melanoma skin cancers, or any other clinical condition threatening the health of the patient or his compliance to the treatment; - concomitant treatment (within 2 weeks of initiating study treatment) with systemic immunomodulatory agents (e.g., glucocorticoids as immunosuppressive agents, interferons) or chemotherapy; - pregnancy [confirmed by a positive urine/serum beta human chorionic gonadropin&#61472;&#61480;&#61538;HCG) test]. Patients who became pregnant during the study will be discontinued from the study; - severe restrictive bronchopneumopathies, interstitial fibrosis, chronic asthma or bronchitis; - previous total load of systemic Bleomycin >90 mg; - monolateral nephropathy or history of nephrolitiasis in the last 5 years; - any clinically significant and persistent laboratory findings obtained during screening, including: alkaline phosphatase (AP), aspartate aminotransferase (AST), alkaline aminotransferase (ALT), &#61543;-glutamyl transferase (&#61543;-GT) or total bilirubin >3 fold upper limit of normal (ULN); pancreatic amylase >1.5 folds ULN; hemoglobin 6 mg/dl, proteinuria >300 mg/day loss, microscopic hematuria presents in 3 consecutive samples in the absence of urinary infection; serum creatinine >1.2 mg/d for women and >1.4 mg/dL for men or creatinine clearance > 100 + 25, Only in patients over sixty years old creatinine clearance will be calculated according to the Cochroft?s formula that is for men: (140 - age of patient) x ideal weight = creatinine clearance 72 x plasmatic creatinine For women the same formula will be multiplied for 0.85. In these patients creatinine clearance must be > 50 mg/min. If creatinine clearance <50 mg/min they must be excluded from the study; - difficulty in swallowing capsules/tablets; Previous treatment with Indinavir is not an exclusion criterion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary endpoint of this study is to evaluate the effects of Indinavir on the clinical response of advanced KS upon debulking therapy with Vinblastine and Bleomicin combined. In particular, the primary endpoints are: to evaluate the rate of complete responses at the end of treatment, including the maintenance phase; to evaluate the rate of complete response, partial response, improved disease, stable disease or progression observed upon the maintenance phase with Indinavir alone, considering the residual debulked tumor (after the induction phase) as the reference point.;Secondary Objective: The secondary endpoints of this study are: to evaluate the entity of partial responses; to determine the time to progression of the enrolled patients; to evaluate the feasibility of the association of Indinavir and chemotherapy; to evaluate the toxicity of Indinavir used in association with chemotherapy; to evaluate the pharmacokinetic profile of Indinavir in the selected patient population; to determine the most relevant biological markers of response and the markers predictive of response to therapy, including plasmatic levels of MMPs, angiogenic factors, circulating endothelial cells and immunoactivation parameters, levels of HHV8 viremia and humoral immune response.;Primary end point(s): Primary objectives of the trial are the evaluation of tumor response to Indinavir and assessment of time to response, duration of response and time to progression. | — |
Countries
Italy
Outcome results
None listed