At a glance
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A Phase I/II of Vorinostat Plus CHOP in Untreated T-cell Non-Hodgkin's Lymphoma
In Brief
A Phase 2 clinical trial evaluating Zolinza (vorinostat), Cyclophosphamide, and 3 other interventions for Lymphoma. Completed, enrolled 14 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to find out how well the drug Zolinza (vorinostat) works in combination with the drug combination called CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) to treat patients with untreated T-cell Non-Hodgkin's Lymphoma (NHL). The safety of these drugs in combination and the best dose of vorinostat when given in combination with CHOP will also be studied.
Study Details
Timeline
Interventions
Up to two 100 mg capsules of Vorinostat (dosage will vary from 100 mg orally (PO) twice daily (BID), 300 mg PO every evening and 200 mg PO BID with the starting dose at 300 mg PO every evening for the phase I trial) are to be administered orally twice daily (once in the morning and once in the evening, or if in the daily dosing cohort once in the evening) in repeated 21-day cycles consisting of 10 days dosing starting on days 5 through 14 followed by a 7-day rest period, during which no vorinostat will be administered.
750 mg/m\^2 by vein over 1 hour on Day 1 of 21 day cycle
50 mg/m\^2 by vein over 15 minutes on Day 1 of 21 day cycle
1.4 mg/m\^2 by vein over 15 minutes on Day 1 of 21 day cycle
100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle