Spots Global Cancer Trial Database for Pomalidomide and Dexamethasone in Treating Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma or Newly Diagnosed or Relapsed or Refractory Intraocular Lymphoma
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Trial Identification
Brief Title: Pomalidomide and Dexamethasone in Treating Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma or Newly Diagnosed or Relapsed or Refractory Intraocular Lymphoma
Official Title: Phase I Trial of Pomalidomide for Patients With Relapsed/Refractory Primary CNS Lymphoma and Primary Vitreoretinal Lymphoma
Study ID: NCT01722305
Conditions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
Dana-Farber Harvard Cancer Center, Boston, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
University of Virginia Cancer Center, Charlottesville, Virginia, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Contact Details
Name: Han Tun
Affiliation: Mayo Clinic
Role: PRINCIPAL_INVESTIGATOR
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