Oral SAHA (Suberoylanilide Hydroxamic Acid) in Advanced Cutaneous T-cell Lymphoma (0683-001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00091559
Recruitment Status : Completed
First Posted : September 14, 2004
Last Update Posted : April 5, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
A study for patients diagnosed with advanced cutaneous T-cell lymphoma (stage 1B or higher) who have progressive, persistent, or recurrent disease on or following 2 other therapies, one of which must have contained Targretin (bexarotene)or for patients who are not candidates or could not tolerate Targretin therapy.

Condition or disease Intervention/treatment Phase
Cutaneous T-cell Lymphoma Sezary Syndrome Mycosis Fungoides Drug: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment 6 Months Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IIb Multicenter Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Advanced Cutaneous T-cell Lymphoma
Actual Study Start Date : February 3, 2005
Actual Primary Completion Date : November 23, 2005
Actual Study Completion Date : March 13, 2006

Primary Outcome Measures :
  1. Objective response rate in patients with progressive, persistent, or recurrent disease.

Secondary Outcome Measures :
  1. Response duration, relief of pruritis, time to progression, time to objective response, safety & tolerability in this population.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with Cutaneous T-cell Lymphoma (Stage 1B or higher)
  • Age: over 18 years of age
  • Have the ability to swallow capsules.
  • You must be at least 3 weeks from any prior chemotherapy or anticancer therapy treatment and have recovered from any side effects of that treatment.
  • Patients also require adequate heart, liver, and kidney function.

Exclusion Criteria:

  • Pregnant and nursing women and those with known allergy to the study drug are excluded from this study.
  • Patients are excluded if they are currently receiving chemotherapy, radiation therapy, or other investigational anti-cancer therapy.
  • Patients diagnosed with HIV, active hepatitis or who require intravenous antibiotics or antifungal agents are not permitted.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00091559

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Study Data/Documents: CSR Snyopsis Links  This link exits the site

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00091559     History of Changes
Other Study ID Numbers: 0683-001
First Posted: September 14, 2004    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017

Keywords provided by Merck Sharp & Dohme Corp.:

Additional relevant MeSH terms:
Lymphoma, T-Cell
Mycosis Fungoides
Sezary Syndrome
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action