Everolimus in Treating Patients With Lymphoma That Has Relapsed or Not Responded to Previous Treatment

• Status: Completed
• Trial end date: 2019-10-09
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Everolimus; Sirolimus

Criteria

DISEASE CHARACTERISTICS:

• Biopsy-proven* relapsed or refractory lymphoma, including the following:

• Aggressive lymphoma (closed to accrual as of 2/7/08 except for diffuse large B cell lymphoma, grade III follicular lymphoma, or transformed lymphoma)

• Transformed lymphoma

• Diffuse large B-cell lymphoma

• Mantle cell lymphoma

• Grade 3 follicular lymphoma

• Precursor B-cell lymphoblastic leukemia/lymphoma

• Mediastinal (thymic) large B-cell lymphoma

• Burkitt's lymphoma/leukemia

• Precursor T-cell lymphoblastic leukemia/lymphoma

• Primary cutaneous anaplastic large cell lymphoma

• Primary systemic type anaplastic large cell lymphoma

• Indolent lymphoma (closed to accrual as of 8/18/08)

• Small lymphocytic lymphoma/chronic lymphocytic leukemia

• Grade 1 or 2 follicular lymphoma

• Extranodal marginal zone B-cell lymphoma of MALT type

• Nodal marginal zone B-cell lymphoma

• Splenic marginal zone B-cell lymphoma

• Uncommon lymphoma (closed to accrual as of 9/2/08)

• Unspecified peripheral T-cell lymphoma

• Anaplastic large cell lymphoma (T and null cell type)

• Lymphoplasmacytic lymphoma (Waldenstrom's macroglobulinemia)

• Central Nervous System (CNS) lymphoma

• Post-transplant lymphoproliferative disorder

• Mycosis fungoides/Sezary syndrome

• Hodgkin's lymphoma

• Primary effusion lymphoma

• Blastic Natural Killer(NK)-cell lymphoma

• Adult T-cell leukemia/lymphoma

• Nasal type extranodal NK/T-cell lymphoma

• Enteropathy type T-cell lymphoma

• Hepatosplenic T-cell lymphoma

• Subcutaneous panniculitis-like T-cell lymphoma

• Angioimmunoblastic T-cell lymphoma

NOTE: *Biopsies performed < 6 months prior to study entry are allowed; biopsy-proven CNS lymphoma (at any time) does not require a re-biopsy in order to be eligible for this study

• Previously treated disease

• Patients with aggressive lymphoma (closed to accrual as of 8/24/07) OR Hodgkin's lymphoma must have received or be ineligible for potentially curative therapy, including stem cell transplantation

• Measurable disease** by CT scan or MRI, defined by 1 of the following:

• At least 1 unidimensionally measurable lesion > 2 cm in diameter

• Skin lesions may be used if they meet this criterion and are photographed with a ruler

• More than 5,000/mm³ tumor cells in the blood

NOTE: **For patients with lymphoplasmacytic lymphoma without measurable lymphadenopathy, measurable disease may be defined by bone marrow lymphoplasmacytosis with > 10% lymphoplasmacytic cells or aggregates, sheets, lymphocytes, plasma cells, or lymphoplasmacytic cells on bone marrow biopsy AND quantitative Immunoglobulin M(IgM) monoclonal protein > 1,000 mg/dL

PATIENT CHARACTERISTICS:

• Eastern Cooperative Oncology Group(ECOG) performance status 0-2

• Life expectancy > 3 months

• Absolute neutrophil count ≥ 1,000/mm³

• Platelet count ≥ 75,000/mm³

• Hemoglobin ≥ 8 g/dL

• Total bilirubin ≤ 2 times upper limit of normal (ULN) OR direct bilirubin ≤ 1.5 times ULN

• aspartate aminotransferase(AST) ≤ 3 times ULN (5 times ULN if liver involvement is present)

• Creatinine ≤ 2 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Willing to provide blood samples and portion of bone marrow aspirate and biopsy during study participation

• Able to swallow intact study medication tablets

• No other life-threatening illness (unrelated to tumor)

• No serious non-malignant disease (e.g., active infection or other condition) that, in the opinion of the investigator, would preclude study participation

• No other active malignancy requiring treatment or that would preclude study participation

• No known HIV positivity

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 3 weeks since prior myelosuppressive chemotherapy or biologic therapy (unless the patient has recovered from the nadir of the previous treatment)

• More than 3 weeks since prior radiotherapy (unless the acute side effects associated with therapy are resolved)

• Concurrent stable (i.e., not increased within the past month) chronic doses of corticosteroids, with a maximum dose of 20 mg of prednisone per day, is allowed if prescribed for disorders other than lymphoma (e.g., rheumatoid arthritis, polymyalgia rheumatica, adrenal insufficiency, or asthma)

• Non-escalating doses of steroids at the lowest possible dosing level are allowed for CNS lymphoma

• No other concurrent investigational ancillary therapy

• No other concurrent chemotherapy, immunotherapy, or radiotherapy

• No concurrent participation in any other clinical trial involving a pharmacologic agent (e.g., drugs, biologics, immunotherapy, or gene therapy) for symptom control or therapeutic intent