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Treatment With Indinavir and Chemotherapy for Advanced Classical Kaposi's Sarcoma

NCT01067690 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2016-08-30

No results posted yet for this study

Summary

The purpose of this study is to determine the clinical response to daily Indinavir oral administration in association with a conventional chemotherapy based on cycles of systemic Vinblastine +/- Bleomycin in patients affected by advanced classical (non HIV-associated) Kaposi's sarcoma

Conditions

  • Kaposi's Sarcoma

Interventions

DRUG

Indinavir in association with Vinblastina +/- Bleomicina

Treatment consists in an induction phase where daily Indinavir (800 mg x 2/die, orally) will be combined together with systemic Vinblastine (10 mg intravenously) +/- Bleomycin (15 mg intramuscularly) in cycles administered every 3 weeks. As maximal response will occur, patients will undergo 2 additional Vinblastine +/- Bleomycin (consolidation) cycles upon continuous treatment with Indinavir. This will be followed by a maintenance phase with Indinavir alone (800 mg x 3/die, orally) in responder patients.

Sponsors & Collaborators

  • Barbara Ensoli, MD, PhD

    lead OTHER

Principal Investigators

  • Lucia Brambilla, MD · Dermatologic Unit, Ospedale Maggiore Policlinico, Milan, Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2015-10-31
Completion
2016-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01067690 on ClinicalTrials.gov