RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Giving vorinostat together with lenalidomide may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when given together with lenalidomide in treating patients with relapsed or refractory Hodgkin lymphoma or non-Hodgkin lymphoma.
PRIMARY OBJECTIVES: I. To assess the safety and tolerability of the combination of lenalidomide and vorinostat. II. To determine the maximum tolerated dose (MTD) and recommended dose of vorinostat and lenalidomide when given in combination in this patient population. SECONDARY OBJECTIVES: I. To obtain preliminary data for response rate, time to response, response duration and time to progression (TTP) for vorinostat and lenalidomide when used in combination. OUTLINE: This is a dose-escalation study of vorinostat. Patients receive oral vorinostat twice daily on days 1-14 and oral lenalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
City of Hope
Duarte, California, United States
Assessment of the Maximum Tolerated Dose and Dose-Limiting Toxicities of the combination of vorinostat and lenalidomide in this patient population
Time frame: Following Cycle 1 of treatment
Number of patients with Grade 3 or above adverse events
Time frame: Day 8 and 22 of Cycle 1 and Day 1 of subsequent cycles and Day 30 following the last dose of study drug
Duration, intensity, and time to onset of toxicities
Time frame: Day 8 and 22 of Cycle 1 and Day 1 of subsequent cycles and Day 30 following the last dose of study drug
AE, laboratory safety assessments, ECOG, ECGs, vital signs, transfusions, hospital days, and antibiotic use
Time frame: Day 8 and 22 of Cycle 1 and Day 1 of subsequent cycles and Day 30 following the last dose of study drug
Objective response rate
Time frame: Every nine weeks on therapy after 2 years a minimum of every 6 months
Time to response
Time frame: Every nine weeks on therapy after 2 years a minimum of every 6 months
Response duration
Time frame: Every nine weeks on therapy after 2 years a minimum of every 6 months
Progression-free survival
Time frame: Every nine weeks on therapy after 2 years a minimum of every 6 months
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