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

Phase 2

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Relapsed aggressive non-Hodgkin lymphoma	Everolimus	Study 1. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Relapsed indolent non-Hodgkin lymphoma	Everolimus	Study 2. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Uncommon lymphomas	Everolimus	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.

Primary Outcome Measures

Name	Time	Method
Tumor Response, Defined by Disease: Chronic Lymphocytic Leukemia(CLL): Clinical Complete or Complete or Nodular Partial or Partial Remission, Waldenstrom: Complete or Partial Response, All Others: Complete or Complete Unconfirmed or Partial Response.	5 years	CLL (subset of patients in the Relapsed Indolent Non-Hodgkin Lymphoma group): 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, \>100000/μL platelets, \>11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions. Waldenstrom (subset of patients in the Uncommon Lymphomas group): \>50% reduction in serum immunoglobulin M(IgM) levels (by serum protein electrophoresis (SPEP)) during any point while in this study, and no appearance of new lesions. All others: at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	5 years	The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival was estimated using the method of Kaplan-Meier.
Progression-free Survival	5 years	Progression-free survival is defined as the time from registration to the time of progression or death due to any cause. Progression-free survival was estimated using the method of Kaplan-Meier. Progression is defined as the following: CLL (subset of patients in the Relapsed Indolent Non-Hodgkin Lymphoma group): \>=50% increase in nodes from nadir or \>=50% increase in liver/spleen size from nadir. Waldenstrom (subset of patients in the Uncommon Lymphomas group): \>50% lymph node increase in SPD of \> 1 node or new nodes, or \>50% liver/spleen size increase, or \> 25% IgM (by SPEP) increase, or lymphocyte morphology transformation to a more aggressive histology. All Others: New lesions or \>=50% lymph nodes.
Time to Progression	5 years	The time to progression is defined as the time from registration to the time of progression. The distribution of time to progression was estimated using the method of Kaplan-Meier.

Locations (3): Mayo Clinic Scottsdale
🇺🇸
Scottsdale, Arizona, United States
Mayo Clinic Cancer Center
🇺🇸
Rochester, Minnesota, United States
Mayo Clinic - Jacksonville
🇺🇸
Jacksonville, Florida, United States