Overview

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

- Safeguard justice