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

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT00127101
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • vorinostat — DRUG
    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.
  • Comparator: bexarotene — DRUG
    Dose escalation with bexarotene 150 mg/m2 capsules rising up to 300 mg/m2 capsules (1 capsule daily). Up to 6 months of treatment.

Study Details

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.

Key Dates

Start date
Sep 30, 2005
Status verified
Apr 2015
Primary completion
Oct 31, 2008
Completion
Oct 31, 2008

Study Design

Enrollment
23 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter\[2\] daily x 7 days per week
  • Experimental: Cohort 2
    Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter\[2\] daily x 7 days per week
  • Experimental: Cohort 2a
    Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter\[2\] daily x 7 days per week
  • Experimental: Cohort 2b
    Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter\[2\] daily x 7 days per week
  • Experimental: Cohort 6
    Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
  • 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)

Primary Outcome Measure

Maximum Tolerated Dose (MTD) as Determined by the Number of Participants With Dose Limiting Toxicities [ Time Frame: Day 1 to day 28 ]

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