Phase 2 Completed N=4 Treatment

Combination Drug Study of Bexarotene and Rosiglitazone to Treat CTCL

Cutaneous T-cell Lymphoma · mycosis fungoides · Sézary syndrome

Source: ClinicalTrials.gov NCT00178841 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2016

Primary outcomePrimary: Number of Participants With a 50% Improvement in Baseline Skin Score — 0 participants

Summary

The purpose of this trial is to determine if combination therapy with rosiglitazone and bexarotene might have a synergistic effect in the treatment of patients with CTCL.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With a 50% Improvement in Baseline Skin Score	—	—
SECONDARY Quality of Life Evaluations	86.25	—
SECONDARY Pruritus Score	5.7	—

Eligibility Criteria

Inclusion Criteria

Patients with biopsy proven persistent or recurrent cutaneous cell lymphoma (CTCL) Stage IA-IVA
Patients with a pathologic proven diagnosis of CTCL that is documented in the patient history.
Patient has preserved organ function.
Patient has an ECOG performance status between 0 - 2.
Women of childbearing potential should be screened for pregnancy prior to treatment and utilize effective contraceptive methods (e.g. barrier) during treatment period.
Patients over the age of 18 who are willing and able to provide Informed Consent
The patient has been taking Targretin capsules for at least the last 4 months and the dose has remained relatively stable.
The patient has had stable or progressive disease over the past 4 months.
Patient has adequate laboratory parameters for liver and kidney function.

Exclusion Criteria

Patients with CD30+ Anaplastic Large Cell Lymphoma
Patients with pathology consistent with peripheral T-cell lymphoma.
Patients with Stage IVB (visceral involvement with CTCL).
Patients with history of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C infection.
Patients with a diagnosis of congestive heart failure.
Patients exhibiting significant edema or unstable cardiovascular disease.
Patients with a fasting triglyceride level greater then 500mg/dl.
Patients that have started any new treatment for CTCL in the past 4 months.
Pregnant women will be excluded from the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00178841). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.