Status:
COMPLETED
Treatment of Classical Non-HIV-Related Kaposi's Sarcoma With the Antiviral Drug Indinavir
Lead Sponsor:
Istituto Superiore di Sanità
Conditions:
Classical Kaposi's Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Recent studies have described a reduced incidence or the regression of Kaposi's sarcoma (KS) in HIV-infected patients treated with the highly active anti-retroviral therapy (HAART) that contains at le...
Detailed Description
Kaposi's sarcoma (KS) is a rare vascular tumor affecting elderly individuals from Mediterranean countries (CKS), post transplant patients and, with increased incidence and aggressiveness, HIV-infected...
Eligibility Criteria
Inclusion
- Have a documented diagnosis of classical KS
- Be HIV-negative
- Be 18 years old and over
- Have one or more of the following: a minimum of 3 measurable progressive lesions; all stages of complicated KS, i.e. showing functional impotency of the affected limbs, lymphedema, lymphorrea or pain; visceral disease; lack of response to conventional therapy (radiotherapy, chemotherapy); contraindication to conventional therapies-
Exclusion
- Presence of life-threatening lesions or other concomitant illness, neoplasia or any other clinical condition threatening the health of the patient or his compliance to the treatment
- Inability to provide informed consent
- Concomitant treatment (within 30 days of initiating study treatment) with systemic immunomodulatory agents (e.g., glucocorticoids as immunosuppressive agents, interferons) or chemotherapy
- Pregnancy
- Impaired clinical conditions (Karnofsky's index \<60
- Diabetes, history of nephrolithiasis or monolateral nephropathy
- Difficulty swallowing capsules/tablets
- Any clinically significant laboratory findings obtained during screening, including:
- Alkaline phosphatase (AP) \>2 fold upper limit of normal (ULN)
- Aspartate aminotransferase (AST)
- Alkaline aminotransferase (ALT)
- Gamma-glutamyl transferase (gamma-GT) or total bilirubin \>3 fold the ULN
- Serum creatinine \>1.2 mg/d for women and \>1.4 mg/dL for men or creatinine clearance \> 100 +/- 25
- Pancreatic amylase \>1.5 folds ULN
- Hemoglobin \<10.0 g/dL for males, \<9.0 g/dL for females
- Platelet count \<75.000/cubic millimeter (mm3)
- Neutrophil count \<850/mm3
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2007
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00362310
Start Date
June 1 2003
End Date
July 1 2007
Last Update
April 14 2008
Active Locations (9)
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1
Centro di Riferimento Oncologico (CRO),
Aviano, Italy
2
Department of Internal Medicine, University of Cagliari
Cagliari, Italy
3
Dermatologic Clinic, Ospedale S. Anna
Ferrara, Italy
4
Ospedale Maggiore, Mangiagalli e Regina Elena, IRCCS,
Milan, Italy