NCT01722305

Pomalidomide and Dexamethasone in Treating Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma or Newly Diagnosed or Relapsed or Refractory Intraocular Lymphoma

Phase I Trial of Pomalidomide for Patients With Relapsed/Refractory Primary CNS Lymphoma and Primary Vitreoretinal Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of pomalidomide when given together with dexamethasone in treating patients with primary central nervous system lymphoma that has come back (relapsed) or does not respond to treatment (refractory) or intraocular lymphoma that is newly diagnosed, relapsed or refractory. Pomalidomide may stimulate the immune system to kill cancer cells. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, stopping them from dividing, or by stopping them from spreading. Giving pomalidomide together with dexamethasone may kill more cancer cells.

Detailed description

PRIMARY OBJECTIVES: I. To establish the maximum tolerated dose (MTD) of pomalidomide in combination with dexamethasone in patients with relapsed/refractory primary central nervous system lymphoma (PCNSL) or primary vitreoretinal lymphoma (PVRL). SECONDARY OBJECTIVES: I. To evaluate the efficacy (overall response rate) and safety of pomalidomide in combination with dexamethasone in patients with PCNSL and PVRL lymphoma in an MTD expanded cohort. II. To evaluate overall survival and progression free survival. TERTIARY OBJECTIVES: I. To study the pharmacokinetics of pomalidomide in the central nervous system. II. To identify the predictive biomarkers for responsiveness to pomalidomide. OUTLINE: This is a dose-escalation study of pomalidomide. Patients receive pomalidomide orally (PO) on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22 of courses 1 and 2. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 2 years.

Conditions

• B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Burkitt Lymphoma
• Central Nervous System Lymphoma
• Intraocular Lymphoma
• Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System
• Recurrent Adult Diffuse Large Cell Lymphoma
• Retinal Lymphoma

Interventions

Type	Name	Description
DRUG	Dexamethasone	Given PO
OTHER	Laboratory Biomarker Analysis	Optional correlative studies
OTHER	Pharmacological Study	Optional correlative studies
DRUG	Pomalidomide	Given PO

Timeline

• Start date: 2013-04-08
• Primary completion: 2016-06-03
• Completion: 2019-07-15
• First posted: 2012-11-06
• Last updated: 2019-07-22

Locations

7 sites across 1 country: United States