Clinical trial · Interventional
An Investigational Study of a Histone Deacetylase (HDAC) Inhibitor Plus Targretin in Cutaneous T-Cell Lymphoma Patients (0683-016)(TERMINATED)
A Phase I Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (Vorinostat; Zolinza) in Combination With Bexarotene in Patients With Advanced Cutaneous T-Cell Lymphoma
NCT00127101CI-TRIAL-00017583terminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was stopped due to low enrollment.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comparator: bexarotene | Drug | — | UNRESOLVED |
| vorinostat | Drug | Vorinostat | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter\[2\] daily x 7 days per week
- interventionNames
- Drug: vorinostat
- Drug: Comparator: bexarotene
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter\[2\] daily x 7 days per week
- interventionNames
- Drug: vorinostat
- Drug: Comparator: bexarotene
- type
- EXPERIMENTAL
- label
- Cohort 2a
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTDummer 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. PMID 22239668