A Study of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Malignant Lymphoma (0683-030)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Lymphoma

Treatments: Drug: vorinostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT00127140

2005_041

0683-030

Details and patient eligibility

About

The primary purpose of this trial is to determine the maximum tolerated dose (MTD), or the maximum acceptable dose (MAD) and evaluate the dose limiting toxicity (DLT) of oral vorinostat in patients with malignant lymphoma.

Enrollment: 10 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who relapsed after complete or partial response, or ineffective in previous chemotherapy

Exclusion criteria

• Patients with history of chemotherapy, antibody therapy, radiotherapy, during the previous 4 weeks (6 months for radioisotope-labeled antibody)
• Any uncontrolled concomitant illness
• Are pregnant or breast-feeding
• Serious drug or food allergy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Vorinostat

Experimental group

Description:

Participants received (Cycle 1) once-daily vorinostat at assigned dose (100 or 200 mg) on Days 1 and 17 and twice-daily on Days 3-16. Thereafter, participants remaining on study received the same dose level therapy twice-daily for 14 consecutive days followed by 7 days of rest.

Treatment:

Drug: vorinostat