RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well everolimus works in treating patients with relapsed or refractory mantle cell lymphoma.
OBJECTIVES: Primary * Evaluation of the efficacy and tolerability of everolimus in patients with relapsed or therapy-resistant mantle cell lymphoma. Secondary * Evaluation of the efficacy of everolimus to induce molecular remission in patients treated with this regimen. * Investigation of immunoglobulin heavy chain variable gene somatic hypermutations (Ig-V\_H) in classical mantle cell lymphoma as compared to blastoid mantle cell lymphoma, in particular in regard to their frequency, mutation distribution pattern (antigen selected vs. at random), and the individually involved Ig-V\_H families. * Evaluation of a putative impact of Ig-V\_H on clinical outcome. OUTLINE: This is a multicenter study. Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Bone marrow and peripheral blood samples are collected periodically and analyzed for molecular response by PCR. Molecular studies are also performed on DNA level formalin-fixed paraffin-embedded tissue samples. After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Bone marrow and peripheral blood samples are collected periodically and analyzed for molecular response by PCR. Molecular studies are also performed on DNA level formalin-fixed paraffin-embedded tissue
CHU de Grenoble - Hopital de la Tronche
Grenoble, France
Hopital Haut Leveque
Pessac, France
Evaluation of the efficacy and tolerability of everolimus
Time frame: Until treatment ends
Evaluation of the efficacy of everolimus to induce molecular remission in patients treated with this regimen.
Time frame: Until treament ends
Investigation of immunoglobulin heavy chain variable gene somatic hypermutations
Investigation of immunoglobulin heavy chain variable gene somatic hypermutations (Ig-V\_H) in classical mantle cell lymphoma as compared to blastoid mantle cell lymphoma, in particular in regard to their frequency, mutation distribution pattern (antigen selected vs. at random), and the individually involved Ig-V\_H families.
Time frame: Until treatment ends
Evaluation of a putative impact of Ig-V_H on clinical outcome.
Time frame: Until treatment ends
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Centre Hospitalier Universitaire Bretonneau de Tours
Tours, France
Institut Gustave Roussy
Villejuif, France
University of Bologna Medical School
Bologna, Italy
European Institute of Oncology
Milan, Italy
Hirslanden Klinik Aarau
Aarau, Switzerland
Kantonsspital Baden
Baden, Switzerland
Universitaetsspital-Basel
Basel, Switzerland
Istituto Oncologico della Svizzera Italiana
Bellinzona, Switzerland
...and 11 more locations