Phase IIb Multicenter Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Advanced Cutaneous T-cell Lymphoma
Data Collection
Bacterial Infections and Mycoses+13
+ Immune System Diseases
+ Immunoproliferative Disorders
Treatment Study
Summary
Study start date: February 3, 2005
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.74 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives