Clinical trial NCT00436618
Conditions: Leukemia Lymphoma Lymphoproliferative Disorder
Keywords: recurrent adult Burkitt lymphoma recurrent adult Hodgkin lymphoma anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma small intestine lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult T-cell leukemia/lymphoma recurrent grade 3 follicular lymphoma recurrent marginal zone lymphoma refractory chronic lymphocytic leukemia recurrent small lymphocytic lymphoma recurrent mycosis fungoides/Sezary syndrome adult nasal type extranodal NK/T-cell lymphoma Waldenstrom macroglobulinemia recurrent adult diffuse large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent mantle cell lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma primary central nervous system non-Hodgkin lymphoma primary central nervous system Hodgkin lymphoma post-transplant lymphoproliferative disorder recurrent adult diffuse small cleaved cell lymphoma
Sponsor: Mayo Clinic
Start date: 2005-08-01; Completion date: 2019-10-09
Enrollment: 277 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.

PURPOSE: This phase II trial is studying the side effects and how well everolimus works in treating patients with lymphoma that has relapsed or not responded to previous treatment.

Detailed description:
OBJECTIVES:

Primary

* Assess the tumor response in patients with relapsed or refractory indolent non-Hodgkin lymphoma (closed to accrual as of 8/18/08), aggressive non-Hodgkin's lymphoma (closed to accrual as of 2/7/08 except for diffuse large B cell lymphoma, grade III follicular lymphoma, or transformed lymphoma), or uncommon lymphoma (closed to accrual as of 9/2/08), including Hodgkin's lymphoma, treated with everolimus.

Secondary

* Evaluate overall survival, progression-free survival, and time to disease progression in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to histology (aggressive lymphoma \[closed to accrual as of 2/7/08 except for diffuse large B cell lymphoma, grade III follicular lymphoma, or transformed lymphoma\] vs indolent lymphoma \[closed to accrual as of 8/18/08\] vs uncommon lymphoma \[closed to accrual as of 9/2/08\]).

Patient receive oral everolimus daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood and tissue collection at baseline and periodically during study treatment for translational research studies. Blood and tissue samples are analyzed for biomarkers to study the effect of everolimus on lymphoma.

After completion of study treatment, patients are followed periodically for up to 5 years.

Arms: arm 1: Study 1. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. arm 2: Study 2. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. arm 3: Study 3. Includes Hodgkin's lymphomas. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Interventions: intervention 1: Everolimus
Intervention descriptions: intervention 1: Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.

Protocol documents: