Trial of Vorinostat in Combination With Cyclophosphamide, Etoposide, Prednisone and Rituximab for Elderly Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT00667615
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to replace a drug with many side effects, procarbazine, with a new novel drug, vorinostat, in a drug combination for the treatment of patients with diffuse large B-cell lymphoma. Vorinostat is the first of a new type of chemotherapy drug, known as a histone deacetylase inhibitor, to be approved by the Food and Drug Administration. It is approved for the treatment of certain lymphomas of the skin. It alters the cancer cell pathway by preventing cancer cells from reproducing. Vorinostat will be added to a combination of four other effective chemotherapy drugs that have been used for many years for the treatment of diffuse large B-cell lymphoma: rituximab, cyclophosphamide, etoposide and prednisone. The doses of vorinostat will be increased or decreased depending on the side effects that occur in each of the first few patients in the trial to find the safest dose with the least side effects. This is termed the phase I part of the clinical trial. Once the best dose of vorinostat is found, the rest of the patients in the clinical trial will be treated with this dose. This is termed the phase II part of the trial. The object of the trial is to find out what effects, good and/or bad, the combination of vorinostat, rituximab, cyclophosphamide, etoposide and prednisone will have on you and your lymphoma.

Key Dates

Start date
Apr 30, 2008
Status verified
Feb 2017
Primary completion
Feb 28, 2017
Completion
Feb 28, 2017

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    vorinostat in combination with cyclophosphamide, etoposide,prednisone and rituximab,peg-filgrastim or filgrastim

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Vorinostat Given Orally for 10 Days in Combination With Cyclophosphamide, Etoposide, Prednisone and Rituximab for Elderly Patients With Relapsed Diffuse Large B-cell Lymphoma [ Time Frame: through study completion, an average of 1 year ]

Locations (5)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer Center @ BaskingRidgeBasking RidgeNew Jersey07920-
Memorial Sloan Kettering Cancer Center @ SuffolkCommackNew York11725-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Weill Cornell Medical CenterNew YorkNew York--
Memorial Sloan Kettering Cancer Center @ PhelpsSleepy HollowNew York10591-

Find similar trials in Basking Ridge, NJ

By research site
Memorial Sloan Kettering Cancer Center @ BaskingRidge· Basking Ridge, NJMemorial Sloan Kettering Cancer Center @ Suffolk· Commack, NYMemorial Sloan Kettering Cancer Center· New York, NYWeill Cornell Medical Center· New York, NYMemorial Sloan Kettering Cancer Center @ Phelps· Sleepy Hollow, NY

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