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

NCT ID: NCT00127140

Last Updated: 2015-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vorinostat

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.

Group Type EXPERIMENTAL

vorinostat

Intervention Type DRUG

Interventions

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vorinostat

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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Watanabe T, Kato H, Kobayashi Y, Yamasaki S, Morita-Hoshi Y, Yokoyama H, Morishima Y, Ricker JL, Otsuki T, Miyagi-Maesima A, Matsuno Y, Tobinai K. Potential efficacy of the oral histone deacetylase inhibitor vorinostat in a phase I trial in follicular and mantle cell lymphoma. Cancer Sci. 2010 Jan;101(1):196-200. doi: 10.1111/j.1349-7006.2009.01360.x. Epub 2009 Sep 10.

Reference Type DERIVED
PMID: 19817748 (View on PubMed)

Other Identifiers

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2005_041

Identifier Type: -

Identifier Source: secondary_id

0683-030

Identifier Type: -

Identifier Source: org_study_id

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