Lenalidomide in Kaposi Disease Associated With HIV Infection

• Status: Terminated
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborator: Celgene Corporation
• Treatments: Lenalidomide; Thalidomide

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

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