Cutaneous T-Cell Lymphoma
Conditions
Interventions
Patients enrolled in phase 1 were treated in sequential cohorts of patients and orally administered bexarotene at a dose level of 150 mg/m2 or 300 mg/m2 once daily within 30 minutes of a meals for 4 w
Sponsors
Minophagen Pharmaceutical Co. Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A clinical diagnosis of cutaneous T-cell lymphoma, CTCL, confirmed by biopsy to be histologically consistent with CTCL diagnosis by a dermatopathologist. stage IIB-IV, stage IB-IIA with refractory to at least one systemic therapy for CTCL. 2. Age>=20 years. 3. Eastern Cooperative Oncology Group, ECOG, performance status Performance Status 0-2 4. Adequate abdominal function as below. A. Adequate renal function as evidenced by serum creatinine =<2.0 mg/dL, or calculated creatinine clearance >=40 mL/min as per the Cockroft and Gault formula. B. Adequate hepatic function that is characterized by aspartate aminotransferase (AST), alanine aminotransferase (ALT), or serum bilirubin more than 2.5 times the upper limit of normal. C. Adequate bone marrow function as evidenced by hemoglobin more than 8 g/dL, absolute neutrophil count more than 1,000/mm3, and platelets more than 50,000/mm3. 5. Fasting serum triglyceride within normal limits, <150 mg/dL, or in treatment with anti-dyslipidaemia. prior to study entry. 6. Females of childbearing potential must have a negative serum beta human chorionic gonadotropin within seven days prior to the initiation of treatment, and must have used highly effective methods of contraception for at least 4 weeks prior to the negative pregnancy test through entry to the study. 7. Male patients with female partners of childbearing potential must agree to practice the effective contraception during the entire period of bexarotene capsule treatment and for at least 1 month after treatment is discontinued. 8. Must be willing and able to give informed consent, complete and understand, either oral or written, study procedures and assessments.
Exclusion criteria
Exclusion criteria: 1. Cutaneous T-cell lymphoma involving the central nervous system 2. Subjects with known adult T-cell leukemia/lymphoma 3. Systemic antibiotic therapy within 2 weeks of entry in the study 4. Topical CTCL therapy, regional chemotherapy, topical steroid and other, within 2 weeks of entry the study 5. PUVA or UVB therapy within 3 weeks 6. Radiation therapy within 4 weeks of entry to the study 7. Systemic anticancer therapy of any kind within 4 weeks of entry to the study 8. Systemic therapy with Vitamin A in doses of greater than 15,000 IU, 5,000 mcg, per day within 4 weeks of entry to the study 9. Received systemic steroids within 4 weeks of entry in the study 10. Participation in any other investigational drug study within 12 week of entry in this study 11.Received Etretinate therapy within one year of entry in the study 12. Patients with pregnancy, intent to become pregnant, breast-feeding or unwillingness to effective contraception. 13. Subjects have critical intercurrent illness or serious infection diseases 14. History of pancreatitis or significant risk factors for developing pancreatitis (e.g., prior pancreatitis, uncontrolled hyperlipidemia, excessive alcohol consumption, uncontrolled diabetes mellitus, biliary tract disease, and medications known to increase triglyceride levels or to be associated with pancreatic toxicity 15. Known or suspected hypersensitivity to bexarotene or any other retinoid preparations 16. Known serious allergic reaction or critical hypersensitivity to drugs 17. Unwillingness or inability to minimize exposure to sunlight and artificial ultraviolet light 18. Principal investigator judged inadequate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endopoint: -Modified Severity-weighted Assessment Tool (mSWAT) -Physician's Global Assessment (PGA) -Composite Assessment of Index Lesion Disease Severity (CA) -abnormal lymph nodes, cutaneous tumors, visceral disease | — |
Countries
Japan
Contacts
Public ContactTsuyoshi Yoshida
Minophagen Pharmaceutical Co. Ltd Regulatory Compliance Department
Outcome results
None listed