An Investigational Study of a Histone Deacetylase (HDAC) Inhibitor Plus Targretin in Cutaneous T-Cell Lymphoma Patients (0683-016)(TERMINATED)

April 2, 2015 updated by: Merck Sharp & Dohme LLC

A Phase I Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (Vorinostat; Zolinza) in Combination With Bexarotene in Patients With Advanced Cutaneous T-Cell Lymphoma

This is an investigational study that increases the dosage to determine the safety/tolerability, and efficacy of a histone deacetylase inhibitor in combination with Targretin in patients with cutaneous T-cell lymphoma in patients who have failed at least one prior systemic therapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Women or men greater than or equal to 18 years of age
  • Advanced cutaneous T-cell lymphoma, stage IB or higher including Sezary Syndrome with progressive, persistent, or recurrent disease
  • Failure of at least one systemic therapy, not including Bexarotene (Targretin)
  • Eastern Cooperative Oncology Group (ECOG) status less than or equal to 2 (measurement to determine your ability to perform daily activities)

Exclusion Criteria:

  • Patient has had investigational treatment in the preceding 30 days
  • Active hepatitis B or C, history of HIV
  • Prior treatment with any HDAC inhibitor
  • Patients must be disease free from prior malignancies for greater than 5 years, except for curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
Drug: vorinostat
Dose escalation study starting with vorinostat 200 mg q.d. capsules (1 capsule daily) and rising up to vorinostat 400 mg q.d. capsules (1 capsule daily). Up to 6 months of treatment.
Other Names:
  • Zolinza
Drug: Comparator: bexarotene
Dose escalation with bexarotene 150 mg/m2 capsules rising up to 300 mg/m2 capsules (1 capsule daily). Up to 6 months of treatment.
Other Names:
  • Targretin
Experimental: Cohort 2
Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
Drug: vorinostat
Dose escalation study starting with vorinostat 200 mg q.d. capsules (1 capsule daily) and rising up to vorinostat 400 mg q.d. capsules (1 capsule daily). Up to 6 months of treatment.
Other Names:
  • Zolinza
Drug: Comparator: bexarotene
Dose escalation with bexarotene 150 mg/m2 capsules rising up to 300 mg/m2 capsules (1 capsule daily). Up to 6 months of treatment.
Other Names:
  • Targretin
Experimental: Cohort 2a
Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
Drug: vorinostat
Dose escalation study starting with vorinostat 200 mg q.d. capsules (1 capsule daily) and rising up to vorinostat 400 mg q.d. capsules (1 capsule daily). Up to 6 months of treatment.
Other Names:
  • Zolinza
Drug: Comparator: bexarotene
Dose escalation with bexarotene 150 mg/m2 capsules rising up to 300 mg/m2 capsules (1 capsule daily). Up to 6 months of treatment.
Other Names:
  • Targretin
Experimental: Cohort 2b
Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
Drug: vorinostat
Dose escalation study starting with vorinostat 200 mg q.d. capsules (1 capsule daily) and rising up to vorinostat 400 mg q.d. capsules (1 capsule daily). Up to 6 months of treatment.
Other Names:
  • Zolinza
Drug: Comparator: bexarotene
Dose escalation with bexarotene 150 mg/m2 capsules rising up to 300 mg/m2 capsules (1 capsule daily). Up to 6 months of treatment.
Other Names:
  • Targretin
Experimental: Cohort 6
Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
Drug: vorinostat
Dose escalation study starting with vorinostat 200 mg q.d. capsules (1 capsule daily) and rising up to vorinostat 400 mg q.d. capsules (1 capsule daily). Up to 6 months of treatment.
Other Names:
  • Zolinza
Drug: Comparator: bexarotene
Dose escalation with bexarotene 150 mg/m2 capsules rising up to 300 mg/m2 capsules (1 capsule daily). Up to 6 months of treatment.
Other Names:
  • Targretin
Experimental: Cohort 7
Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)
Drug: vorinostat
Dose escalation study starting with vorinostat 200 mg q.d. capsules (1 capsule daily) and rising up to vorinostat 400 mg q.d. capsules (1 capsule daily). Up to 6 months of treatment.
Other Names:
  • Zolinza
Drug: Comparator: bexarotene
Dose escalation with bexarotene 150 mg/m2 capsules rising up to 300 mg/m2 capsules (1 capsule daily). Up to 6 months of treatment.
Other Names:
  • Targretin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Tolerated Dose (MTD) as Determined by the Number of Participants With Dose Limiting Toxicities
Time Frame: Day 1 to day 28
Number of patients with Dose Limiting Toxicities (DLT). A DLT is an adverse event that determined the treatment dose level was not tolerable for that patient in Cycle 1.
Day 1 to day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Responded to Treatment
Time Frame: Every 28 days for up to 6 Months of Treatment

Disease burden as assessed by the pre-specified Severity Weighted Assessment Tool (SWAT) measurement. A Response is defined as equal to or greater than 50% improvement in SWAT score.

SWAT Score is determined by the Lesions classified as patch, plaque, or tumor. The sum of percent of total body surface area (%TBSA) by lesion type is derived and multiplied by a factor of 1 (for patch), 2 (for plaque), or 4 (for tumor). The skin score total is derived by summing the skin score subtotals for patches, plaques and tumors. The skin score total is dimensionless and can range from 0 to 400
Every 28 days for up to 6 Months of Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

August 2, 2005

First Submitted That Met QC Criteria

August 4, 2005

First Posted (Estimate)

August 5, 2005

Study Record Updates

Last Update Posted (Estimate)

April 21, 2015

Last Update Submitted That Met QC Criteria

April 2, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0683-016
  • MK0683-016
  • 2005_019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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