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


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) as Determined by the Number of Participants With Dose Limiting Toxicities

Outcome Description:

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.

Outcome Time Frame:

Day 1 to day 28

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

United States: Food and Drug Administration

Study ID:

2005_019

NCT ID:

NCT00127101

Start Date:

September 2005

Completion Date:

October 2008

Related Keywords:

  • Lymphoma
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous

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