Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Merck |
---|---|
Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00127101 |
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.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: vorinostat Drug: Comparator: bexarotene |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Phase I Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (Vorinostat; Zolinza) in Combination With Bexarotene in Patients With Advanced Cutaneous T-Cell Lymphoma |
Enrollment: | 23 |
Study Start Date: | September 2005 |
Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Cohort 1: Experimental
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.
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.
|
Cohort 2: Experimental
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.
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.
|
Cohort 2a: Experimental
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.
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.
|
Cohort 2b: Experimental
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.
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.
|
Cohort 6: Experimental
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.
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.
|
Cohort 7: Experimental
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.
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.
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2005_019, MK0683-016 |
Study First Received: | August 2, 2005 |
Results First Received: | July 6, 2009 |
Last Updated: | August 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00127101 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anti-Inflammatory Agents Anticarcinogenic Agents Immunoproliferative Disorders Vorinostat Sezary Syndrome Mycosis Fungoides Mycoses Lymphatic Diseases Analgesics, Non-Narcotic Cutaneous T-cell Lymphoma |
Bexarotene Lymphoma, T-Cell Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Lymphoma, T-Cell, Cutaneous |
Anti-Inflammatory Agents Anticarcinogenic Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Sezary Syndrome Mycosis Fungoides Bexarotene Sensory System Agents Lymphoma, T-Cell Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Lymphoma Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Vorinostat Enzyme Inhibitors Protective Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Central Nervous System Agents Lymphoma, T-Cell, Cutaneous |