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

NCT ID: NCT00127101

Last Updated: 2015-04-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2008-10-31

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter\[2\] daily x 7 days per week

Group Type: EXPERIMENTAL

vorinostat

Intervention Type: 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

Intervention Type: 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.

Cohort 2

Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter\[2\] daily x 7 days per week

Group Type: EXPERIMENTAL

vorinostat

Intervention Type: 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

Intervention Type: 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.

Cohort 2a

Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter\[2\] daily x 7 days per week

Group Type: EXPERIMENTAL

vorinostat

Intervention Type: 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

Intervention Type: 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.

Cohort 2b

Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter\[2\] daily x 7 days per week

Group Type: EXPERIMENTAL

vorinostat

Intervention Type: 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

Intervention Type: 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.

Cohort 6

Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week

Group Type: EXPERIMENTAL

vorinostat

Intervention Type: 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

Intervention Type: 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.

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)

Group Type: EXPERIMENTAL

vorinostat

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Zolinza; Targretin

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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Dummer R, Beyer M, Hymes K, Epping MT, Bernards R, Steinhoff M, Sterry W, Kerl H, Heath K, Ahern JD, Hardwick JS, Garcia-Vargas J, Baumann K, Rizvi S, Frankel SR, Whittaker SJ, Assaf C. Vorinostat combined with bexarotene for treatment of cutaneous T-cell lymphoma: in vitro and phase I clinical evidence supporting augmentation of retinoic acid receptor/retinoid X receptor activation by histone deacetylase inhibition. Leuk Lymphoma. 2012 Aug;53(8):1501-8. doi: 10.3109/10428194.2012.656625. Epub 2012 Feb 13.

Reference Type: RESULT

PMID: 22239668 (View on PubMed)

Other Identifiers

MK0683-016

Identifier Type: -

Identifier Source: secondary_id

2005_019

Identifier Type: -

Identifier Source: secondary_id

0683-016

Identifier Type: -

Identifier Source: org_study_id