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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 2

Conditions

Cutaneous T-cell Lymphoma
Mycosis Fungoides
Sezary Syndrome

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00091559
0683-001
2004_015

Details and patient eligibility

About

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.

Enrollment

74 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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