Phase II Trial for the Treatment of Advanced Classical Kaposi?s Sarcoma with the HIV Protease Inhibitor Indinavir in Combination with Chemotherapy - ND

Phase 1

• Conditions: patients with advanced Kaposi sarcoma, stage III/IV; MedDRA version: 9.1Level: LLTClassification code 10023287Term: Kaposi's sarcoma classical

• Registration Number: EUCTR2007-000567-26-IT
• Lead Sponsor: ISTITUTO SUPERIORE DI SANITA`

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-20
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

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

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 <10.0 g/dL for males, <9.0 g/dL for females; platelet count <100.000/cubic millimeter (mm3); neutrophil count <1500/mm3; uricemia >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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified