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Lenalidomide in Kaposi Disease Associated With HIV Infection

NCT01282047

TerminatedPhase 2

Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Conditions: HIV Infection Associated Kaposi Disease

Interventions: Lenalidomide

Countries: France

Lenakap : This multicenter, non randomized (single arm), open, phase II study aims to evaluated the efficacy of Lenalidomide in HIV-associated kaposi disease. Patients will be followed for 48 weeks. Measurement of primary endpoint will be at 24 weeks.

Eligibility overview

Sex: ALL

Age: 19 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Men or non childbearing (negative serum Human Chorionic Gonadotropin-hCG) non breastfeeding women who practice adequate birth control, maintained 4 weeks after stopping lenalidomide
* Age over 18 years and below 75 years
* Able and willing to give written informed consent
* Serologic documentation of HIV infection by approved tests, undetectable HIV viral load (below 50 copies/mL) independently of CD4 cell counts
* Biopsy proven symptomatic Kaposi sarcoma with at least 4 measurable cutaneous lesions
* Treatment by cART for at least 12 months, without wash out the last 6 months with undetectable HIV-RNA (below 50 copies/mL)
* History of treatment failure or relapse with 1 or more chemotherapy
* Progressive disease with need to new specific therapy
* Wash-out over 4 weeks if previous specific Kaposi sarcoma chemotherapy (8 weeks if Interferon -IFN therapy)
* Karnofsky performance status over 70%
* Social security (State Medical Assistance is not a social security scheme)
* Agree to abstain from donating blood
* Agree not to donate semen
* Agree not to share study drug with another person

Exclusion Criteria:

* Childbearing or breastfeeding (positive betaHCG serum)
* Kaposi sarcoma with only visceral locations
* Kaposi sarcoma with cardiac and/or bronchopulmonary localisations
* 2 viral loads over 50 copies/mL under Highly active antiretroviral therapy (HAART), during the last 6 months
* Opportunistic infections, uncontrolled infections
* Cardiac disease
* Castleman disease or lymphoma
* Other cancers or previous or current haematological malignancies
* Polyneuritis, grade over 2
* Association with neurotoxic drugs such as isoniazid, d4T
* Neutrophil polynuclear count below 1000/mm3 or platelets below 75000/mm3
* Life expectation under 2 months
* Creatinine clearance below or equal 50 mL/min (Cockcroft-Gault formula)
* Serum Glutamopyruvate Transferase (SGPT) or Serum Glutamooxaloacetate Transferase (SGOT) over or equal 3
* Concomitant treatment with antineoplastic drugs
* Known allergy or hypersensitivity to aspirin, to lenalidomide
* Contraindication to anticoagulant drugs
* Safeguard justice

Locations (1)

Clamart, France, France