Oral SAHA (Suberoylanilide Hydroxamic Acid) in Advanced Cutaneous T-cell Lymphoma (0683-001)

Mycosis Fungoides Clinical Trial

Official title:

Phase IIb Multicenter Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Advanced Cutaneous T-cell Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00091559
• Other study ID #: 0683-001
• Secondary ID: 2004_015
• Status: Completed
• Phase: Phase 2
• First received: September 10, 2004
• Last updated: April 3, 2017
• Start date: February 3, 2005
• Est. completion date: March 13, 2006

Study information

• Verified date: April 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: March 13, 2006
• Est. primary completion date: November 23, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cutaneous T-cell Lymphoma
• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Mycoses
• Mycosis Fungoides
• Sezary Syndrome

Intervention

Drug:
• MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment 6 Months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (2)

Fantin 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. — View Citation

Olsen 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. Epub 2007 Jun 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate in patients with progressive, persistent, or recurrent disease.
Secondary	Response duration, relief of pruritis, time to progression, time to objective response, safety & tolerability in this population.