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

NCT01067690 | Completed Phase 2

• 1 other identifier: CKS/IND-CX/05
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

classical Kaposi's sarcoma; chemotherapy; indinavir; HIV protease inhibitor; Advanced classical (non HIV-associated) Kaposi's sarcoma

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• 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)

Interventions

Indinavir in association with Vinblastina +/- Bleomicina DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barbara Ensoli, MD, PhD: lead

Study Sites (1)

Dermatologic Unit, Ospedale Maggiore Policlinico, Milan, Italy

Milan, Italy, 20100, Italy

Location

Related Publications (5)

• Ensoli B, Sturzl M, Monini P. Cytokine-mediated growth promotion of Kaposi's sarcoma and primary effusion lymphoma. Semin Cancer Biol. 2000 Oct;10(5):367-81. doi: 10.1006/scbi.2000.0329.

  PMID: 11100885 BACKGROUND

• Sgadari C, Barillari G, Toschi E, Carlei D, Bacigalupo I, Baccarini S, Palladino C, Leone P, Bugarini R, Malavasi L, Cafaro A, Falchi M, Valdembri D, Rezza G, Bussolino F, Monini P, Ensoli B. HIV protease inhibitors are potent anti-angiogenic molecules and promote regression of Kaposi sarcoma. Nat Med. 2002 Mar;8(3):225-32. doi: 10.1038/nm0302-225.

  PMID: 11875492 BACKGROUND

• Sgadari C, Monini P, Barillari G, Ensoli B. Use of HIV protease inhibitors to block Kaposi's sarcoma and tumour growth. Lancet Oncol. 2003 Sep;4(9):537-47. doi: 10.1016/s1470-2045(03)01192-6.

  PMID: 12965274 BACKGROUND

• Monini P, Sgadari C, Toschi E, Barillari G, Ensoli B. Antitumour effects of antiretroviral therapy. Nat Rev Cancer. 2004 Nov;4(11):861-75. doi: 10.1038/nrc1479.

  PMID: 15516959 BACKGROUND

• Monini P, Sgadari C, Grosso MG, Bellino S, Di Biagio A, Toschi E, Bacigalupo I, Sabbatucci M, Cencioni G, Salvi E, Leone P, Ensoli B. Clinical course of classic Kaposi's sarcoma in HIV-negative patients treated with the HIV protease inhibitor indinavir. AIDS. 2009 Feb 20;23(4):534-8. doi: 10.1097/QAD.0b013e3283262a8d.

  PMID: 19169139 BACKGROUND

MeSH Terms

Conditions

Sarcoma, Kaposi

Interventions

Indinavir; Association

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Psychotherapeutic Processes; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lucia Brambilla, MD

  Dermatologic Unit, Ospedale Maggiore Policlinico, Milan, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 10, 2010
• First Posted: February 11, 2010
• Study Start: June 1, 2008
• Primary Completion: October 1, 2015
• Study Completion: June 1, 2016
• Last Updated: August 30, 2016

Record last verified: 2016-08

Locations

IT (1)