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Vorinostat and Lenalidomide in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma

2014-08-27 03:13:59 | BioPortfolio

Summary

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.

Description

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Adult Nasal Type Extranodal NK/T-cell Lymphoma

Intervention

lenalidomide, vorinostat, laboratory biomarker analysis

Location

City of Hope
Duarte
California
United States
91010

Status

Recruiting

Source

City of Hope Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:59-0400

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Medical and Biotech [MESH] Definitions

Fluid obtained by irrigation or washout of the nasal cavity and NASAL MUCOSA. The resulting fluid is used in cytologic and immunologic assays of the nasal mucosa such as with the NASAL PROVOCATION TEST in the diagnosis of nasal hypersensitivity.

A condition in which there is a change of one adult cell type to another similar adult cell type.

The proximal portion of the respiratory passages on either side of the NASAL SEPTUM. Nasal cavities, extending from the nares to the NASOPHARYNX, are lined with ciliated NASAL MUCOSA.

Application of allergens to the nasal mucosa. Interpretation includes observation of nasal symptoms, rhinoscopy, and rhinomanometry. Nasal provocation tests are used in the diagnosis of nasal hypersensitivity, including RHINITIS, ALLERGIC, SEASONAL.

Diagnostic measurement of the nose and its cavity through acoustic reflections. Used to measure nasal anatomical landmarks, nasal septal deviation, and nasal airway changes in response to allergen provocation tests (NASAL PROVOCATION TESTS).

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