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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01067690
Recruitment Status : Completed
First Posted : February 11, 2010
Last Update Posted : August 30, 2016
Information provided by (Responsible Party):
Barbara Ensoli, MD, PhD, Istituto Superiore di Sanità

February 10, 2010
February 11, 2010
August 30, 2016
June 2008
October 2015   (Final data collection date for primary outcome measure)
to determine the rate of complete responses at the end of treatment (including the maintenance phase) and of clinical responses after the maintenance phase, considering the residual debulked tumour (after the induction phase) as the reference point.
Same as current
Complete list of historical versions of study NCT01067690 on Archive Site
to determine time to tumor progression, treatment tolerability, indinavir pharmacokinetic profile, biological markers of response (ie. angiogenesis and immunoactivation parameters, HHV8 viral load and immune response)
Same as current
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Treatment With Indinavir and Chemotherapy for Advanced Classical Kaposi's Sarcoma
Phase II Trial for the Treatment of Advanced Classical Kaposi's Sarcoma With the HIV Protease Inhibitor Indinavir in Combination With Chemotherapy
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
It has been recently demonstrated that HIV protease inhibitors (HIV-PI) exert direct anti-angiogenic and anti-tumor actions by blocking endothelial and tumor cell invasion and matrix metalloprotease (MMP) activity. Based on this data, we have started a phase II trial for the treatment of HIV-negative patients with CKS with the HIV-PI Indinavir. Indinavir was well tolerated and induced KS regression/improvement in early-stage disease, and prolonged stabilization in late-stage KS. Response required high plasma drug concentrations indicating a "therapeutic" drug threshold, and was associated with a decrease of circulating endothelial cells (CEC), basic fibroblast growth factor and MMP2 plasma levels. However, large, confluent tumor masses were generally not responsive (Monini et al, AIDS 2009). Thus, advanced KS may benefit at best by treatment with IND upon tumor debulking by conventional chemotherapy.
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Kaposi's Sarcoma
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.
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2016
October 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Documented diagnosis of KS
  • Negative HIV ELISA test
  • Being classified as stage III or IV
  • Age ≥18 years
  • Having interrupted any other anti-KS therapy since at least 2 weeks
  • Being informed about the nature of the study and having signed the informed consent

Exclusion Criteria:

  • Inability to give informed consent
  • Presence of other concomitant diseases, neoplasia (excluding cutaneous tumors with limited extension and without diagnosis of melanoma) or any other life-threatening clinical condition that would compromise its compliance to the protocol
  • Concomitant treatments (within 2 weeks prior to the study) with systemic immunomodulatory agents (i.e. glucocorticoids used as immunosuppressive agents, interferons) or chemotherapy
  • Pregnancy
  • Monolateral nephropathy or history of nephrolithiasis during the last 5 years
  • Any clinically relevant and persistent alteration of laboratory values observed during screening
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
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Barbara Ensoli, MD, PhD, Istituto Superiore di Sanità
Barbara Ensoli, MD, PhD
Not Provided
Principal Investigator: Lucia Brambilla, MD Dermatologic Unit, Ospedale Maggiore Policlinico, Milan, Italy
Istituto Superiore di Sanità
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP