Clinical trial · Interventional
Oral SAHA (Suberoylanilide Hydroxamic Acid) in Advanced Cutaneous T-cell Lymphoma (0683-001)
Phase IIb Multicenter Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Advanced Cutaneous T-cell Lymphoma
NCT00091559CI-TRIAL-00026810completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A study for patients diagnosed with advanced cutaneous T-cell lymphoma (stage 1B or higher) who have progressive, persistent, or recurrent disease on or following 2 other therapies, one of which must have contained Targretin (bexarotene)or for patients who are not candidates or could not tolerate Targretin therapy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous T-cell Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Mycosis Fungoides | Mycosis Fungoides | ONTOLOGY_EXACT | 0.98 |
| Sezary Syndrome | Sezary Syndrome | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment 6 Months | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective response rate in patients with progressive, persistent, or recurrent disease.
Secondary outcomes (1)
- measure
- Response duration, relief of pruritis, time to progression, time to objective response, safety & tolerability in this population.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with Cutaneous T-cell Lymphoma (Stage 1B or higher) * Age: over 18 years of age * Have the ability to swallow capsules. * You must be at least 3 weeks from any prior chemotherapy or anticancer therapy treatment and have recovered from any side effects of that treatment. * Patients also require adequate heart, liver, and kidney function. Exclusion Criteria: * Pregnant and nursing women and those with known allergy to the study drug are excluded from this study. * Patients are excluded if they are currently receiving chemotherapy, radiation therapy, or other investigational anti-cancer therapy. * Patients diagnosed with HIV, active hepatitis or who require intravenous antibiotics or antifungal agents are not permitted.
References
Publications (2)
- BACKGROUNDOlsen EA, Kim YH, Kuzel TM, Pacheco TR, Foss FM, Parker S, Frankel SR, Chen C, Ricker JL, Arduino JM, Duvic M. Phase IIb multicenter trial of vorinostat in patients with persistent, progressive, or treatment refractory cutaneous T-cell lymphoma. J Clin Oncol. 2007 Jul 20;25(21):3109-15. doi: 10.1200/JCO.2006.10.2434. Epub 2007 Jun 18. PMID 17577020
- BACKGROUNDFantin VR, Loboda A, Paweletz CP, Hendrickson RC, Pierce JW, Roth JA, Li L, Gooden F, Korenchuk S, Hou XS, Harrington EA, Randolph S, Reilly JF, Ware CM, Kadin ME, Frankel SR, Richon VM. Constitutive activation of signal transducers and activators of transcription predicts vorinostat resistance in cutaneous T-cell lymphoma. Cancer Res. 2008 May 15;68(10):3785-94. doi: 10.1158/0008-5472.CAN-07-6091. PMID 18483262