Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

This is a multicenter, randomized, open-label, Phase IV study to assess the efficacy, tolerability and safety of two initial dose levels of bexarotene capsules in patients with refractory cutaneous T-cell lymphoma (CTCL).

Eligibility Criteria

Inclusion Criteria:

1. A clinical diagnosis of cutaneous T-cell lymphoma (CTCL) without central nervous system (CNS) involvement, confirmed by biopsy to be histologically consistent with CTCL diagnosis by a dermatopathologist.

2. Refractory to at least one systemic therapy for CTCL. (Refractory is defined as resistance to therapy due either to lack of response of at least 50% improvement or progression of disease while still on therapy after an initial response).

3. Systemic therapy for CTCL is indicated.

4. A Karnofsky performance score ≥ 60%.

5. Age ≥18 years.

6. Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (ß-hCG) with a sensitivity of at least 50 mIU/L within seven days prior to the initiation of treatment. Females of childbearing potential must have used simultaneously two highly effective methods of contraception (strongly recommended that one of the two forms of contraception be non-hormonal such as condom plus spermicide, condom plus diaphragm with spermicide, or have a vasectomized partner) or use an intrauterine device or must have been sexually abstinent for at least four weeks prior to or at least one menstrual cycle prior to (whichever is longer) the negative pregnancy test through entry in the study. Sexual abstinence or effective contraception must be used for at least one month prior to the initiation of therapy, during therapy, and for at least one month following discontinuation of therapy. Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.

7. Male patients with female partners of childbearing potential must agree to sexual abstinence or to practice two reliable forms of effective contraception used simultaneously (strongly recommended that one of the two forms of contraception be non-hormonal such as condom plus spermicide, condom plus diaphragm with spermicide, or partner with tubal ligation) or partner may use an intrauterine device, during the entire period of Targretin capsule treatment and for at least one month after treatment is discontinued. Male patients with female sexual partners who are pregnant, possibly pregnant or who could become pregnant during the study must agree to use condoms during sexual intercourse during the entire period of Targretin capsule treatment and for at least one month after the last dose of Targretin capsules.

8. Must be willing and able to give informed consent, complete and understand, either oral or written, study procedures and assessments.

9. Patient must be suitable for participation in the study in the investigator's opinion.

10. Fasting serum triglyceride within normal limits (<150 mg/dL) prior to study entry.

11. 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.

12. Adequate hepatic function that is characterized by aspartate aminotransferase (SGOT [AST]), alanine aminotransferase (SGPT [ALT]), or serum bilirubin < 2.5 times the upper limit of normal.

13. Adequate bone marrow function as evidenced by hemoglobin ≥ 8 g/dL, absolute neutrophil count (ANC) ≥ 1,000/mm3, and platelets ≥ 50,000/mm3.

Exclusion Criteria

1. Cutaneous T-cell lymphoma involving the central nervous system.

2. Patients with known Human Immunodeficiency Virus (HIV) infection and active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection (HBV/ HCV or HIV testing is not required for the purpose of this study)

3. Participation in any other investigational drug study within thirty (30) days of entry in this study.

4. Within five (5) years after the onset of menopause.

5. Received systemic corticosteroids within six (6) months of entry in the study.

6. Known hypersensitivity to bexarotene or other component of Targretin capsules.

7. Pregnancy, intent to become pregnant, or breast-feeding.

8. Received gemfibrozil within one (1) day of starting the study.

9. Prior therapy for the treatment of CTCL:

1. PUVA or UVB therapy within three (3) weeks of study entry

2. EBT or photopheresis within three (3) weeks of study entry

3. Topical retinoids, nitrogen mustard, BCNU, imiquimod, etc. within two (2) weeks of study entry If antipruritic medication cannot be avoided, antihistamine or antipruritic agents must be administered using a stable dose regimen for at least one (1) week prior to initiation of study drug treatment and throughout the study, unless it is determined that a discontinuation or reduction in dose is indicated. Prior to the enrollment of any patient who will be taking systemic or dermatologically-applied antihistamine or anti-pruritic agent, the investigator must contact Eisai to discuss the need for such agent. Mineral oil, baby oil, and simple moisturizing lotions may be used as emollients. Low- to mid- potency topical corticosteroids are allowed ONLY for patients with erythroderma (stage III/IV CTCL) using a stable dose regimen for at least four (4) weeks prior to study entry. High potency topical corticosteroids and tar baths are NOT permitted.

NOTE: Prior to the enrollment of any patient who will be taking systemic or dermatologically-applied antihistamine or anti-pruritic agent, the investigator must contact the Sponsor to discuss the need for such agent.

4. Anticancer therapy of any kind (e.g., methotrexate, cyclophosphamide, vorinostat, romidepsin, interferon, etc) within thirty (30) days of entry to the study. Patient must recover from all signs of toxicity prior to entry in the study.

5. Oral retinoid therapy for any indication within three (3) months of study entry

6. Systemic therapy with Vitamin A in doses of greater than 15,000 IU (5,000 mcg) per day (equivalent to approximately three times RDA) within thirty (30) days of entry in this study).

10. Systemic antibiotic therapy within two (2) weeks of entry in the study. (Patients with infections requiring antibiotics or likely to require antibiotics should be appropriately treated with a course of antibiotics terminating at least two weeks prior to entry, or if indicated, a chronic suppressive or prophylactic dose of antibiotics stabilized at least two (2) weeks prior to entry. Patients who require initiation of or changes in antibiotic therapy during the study will not be considered a violation of this protocol).

11. 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).

12. Unwillingness or inability to minimize exposure to sunlight and artificial ultraviolet light while receiving Targretin capsules.

Trial Contact Information

Trial Lead Organizations/Sponsors

Eisai Incorporated

Gary Palmer, MD

Study Director

Gail Howard		Ph: 201-746-2702
		Email: gail_howard@eisai.com

U.S.A.
Alabama
	Birmingham
	UAB Comprehensive Cancer Center
		Laura Bradford	Ph: 205-502-9967
			Email: lbradford@uabmc.edu
		S. Lauren Hughey, MD	Principal Investigator
Florida
	Miami
	Florida Academic Dermatology Center, LLC
		Annika Grant	Ph: 305-324-2110
		Francisco A. Kerdel	Principal Investigator
Georgia
	Atlanta
	Winship Cancer Institute of Emory University
		Bridget Bradley	Ph: 404-778-3084
		Sareeta Parker, MD	Principal Investigator
Illinois
	Chicago
	Rush Cancer Institute at Rush University Medical Center
		Claudia Riechelmann-Malik	Ph: 312-563-4001
			Email: claudia_riechelmann-malik@rush.edu
		Michael Tharp, MD	Principal Investigator
Louisiana
	New Orleans
	Tulane Cancer Center at Tulane University Hospital and Clinic
		Edward Coleman	Ph: 504-988-5135
		Erin Boh, MD	Principal Investigator
Michigan
	Ann Arbor
	University of Michigan Comprehensive Cancer Center
		Kathryn Keeley	Ph: 734-936-4075
			Email: ktkeeley@med.umich.edu
		Thomas Anderson, MD	Principal Investigator
Minnesota
	Minneapolis
	Masonic Cancer Center at University of Minnesota
		Rina Farah	Ph: 612-625-4973
			Email: fara0050@umn.edu
		Kimberly Bohjanen, MD	Principal Investigator
Missouri
	St. Louis
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Ann Martin, MD	Ph: 314-362-8171
		Ann Martin, MD	Principal Investigator
New York
	Rochester
	James P. Wilmot Cancer Center at University of Rochester Medical Center
		Brian Poligone, MD	Ph: 585-276-4673
		Brian Poligone, MD	Principal Investigator
North Carolina
	Durham
	Duke Cancer Institute
		Annie Tsui	Ph: 919-668-5610
			Email: annie.tsui@duke.edu
		Elise Olsen, MD	Principal Investigator
	Winston-Salem
	Wake Forest University Comprehensive Cancer Center
		Julie Fountain	Ph: 336-716-3775
		Alan Fleischer, MD	Principal Investigator
Ohio
	Cleveland
	Case Comprehensive Cancer Center
		Kelly Jeffords	Ph: 216-983-0661
		Neil Korman, MD	Principal Investigator
Pennsylvania
	Pittsburgh
	UPMC Cancer Centers
		Sue McCann	Ph: 412-864-3681
		Larissa Geskin, MD	Principal Investigator
Tennessee
	Nashville
	Vanderbilt-Ingram Cancer Center
		Brigitta Brannon	Ph: 615-936-1133
			Email: brigitta.brannon@vanderbilt.edu
		John Zic, MD	Principal Investigator
Texas
	Dallas
	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
		Mia Ashe-Randolph	Ph: 214-645-8968
		Amit Pandya, MD	Principal Investigator
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Carol Wilson	Ph: 713-563-4655
			Email: clwilson@mdanderson.org
		Madeleine D. Duvic	Principal Investigator
Utah
	Salt Lake City
	Huntsman Cancer Institute at University of Utah
		Chris Hamatake	Ph: 801-587-7604
		Glen Bowen, MD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01007448
Information obtained from ClinicalTrials.gov on January 08, 2012

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