CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
Zolinza (vorinostat) +4 moredrug
Likely dose
Zolinza (vorinostat) 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00787527
NCT00787527Phase 2Completed

A Phase I/II of Vorinostat Plus CHOP in Untreated T-cell Non-Hodgkin's Lymphoma

M.D. Anderson Cancer Center·interventional·Posted Nov 7, 2008·Updated Sep 9, 2014

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesUnited States

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 7, 2008
Enrollment StartNov 1, 2008
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 17.7 years ago

Interventions

Zolinza (vorinostat)drug

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.

Cyclophosphamidedrug

750 mg/m\^2 by vein over 1 hour on Day 1 of 21 day cycle

Doxorubicindrug

50 mg/m\^2 by vein over 15 minutes on Day 1 of 21 day cycle

Vincristinedrug

1.4 mg/m\^2 by vein over 15 minutes on Day 1 of 21 day cycle

Prednisonedrug

100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle