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Clinical Trial Name - An Investigational Study of a Histone Deacetylase (HDAC) Inhibitor Plus Targretin in Cutaneous T-C
| Original Study ID : 2005_019 |
| Secondary ID : MK0683-016 |
| NCT ID : NCT00127101 |
| Brief Title : An Investigational Study of a Histone Deacetylase (HDAC) Inhibitor Plus Targretin in Cutaneous T-Cell Lymphoma Patients |
| Official Title : A Phase I Clinical Trial of Oral Suberoylanilide Hydroxamic Acid in Combination With Bexarotene in Patients With Advanced Cutaneous T-Cell Lymphoma |
| Brief Summary : 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. |
| Source : Merck |
| Overall Status : Terminated |
| Start Date : August 2005 |
| End Date : October 2008 |
| Completion Date : October 2008 |
| Official Title : Phase 1 |
| Phase : Interventional |
| Study Design : Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study |
| Enrollment : 42 |
| Verification Date : May 2009 |
| First Received Date : August 2, 2005 |
| Trial Eligibility |
| Criteria : 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 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 |
| Gender : Both |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| OutComes |
| Primary OutComes |
| Measure : Maximum tolerated dose (MTD) |
| Time Frame : Up to 6 months of treatment |
| Safety issue : No |
| Secondary OutComes |
| Measure : response rate |
| Time Frame : Up to 6 months of treatment |
| Safety issue : Yes |
| Interventions |
| Type : Drug |
| Name : vorinostat |
| Description : 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. |
| Type : Drug |
| Name : Comparator: bexarotene |
| Description : Dose escalation with bexarotene 150 mg/m2 capsules rising up to 300 mg/m2 capsules (1 capsule daily). Up to 6 months of treatment. |
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