Study Evaluating Two Dose Levels of Targretin Capsules in Patients With Refractory Cutaneous T-cell Lymphoma (CTCL)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT01007448
First received: November 3, 2009
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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).


Condition Intervention Phase
Refractory Cutaneous T-cell Lymphoma
Drug: bexarotene
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV Randomized Study Of Two Dose Levels Of Targretin~ Capsules In Patients With Refractory Cutaneous T-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:
  • Tumor responses (clinical complete and partial): Composite Assessment of Index Lesion Disease Severity (CA); Physician's Global Assessment of Clinical Condition (PGA); Percent Body Surface Area Involvement (BSA) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to cutaneous tumor response; Response duration; Time to cutaneous tumor progression [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: bexarotene 150mg/m2/day Drug: bexarotene
150 mg/m2/day oral bexarotene capsules
Other Name: Targretin
Active Comparator: bexarotene 300 mg/m2/day Drug: bexarotene
300 mg/m2/day oral bexarotene capsules
Other Name: Targretin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01007448

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, Florida
Florida Academic Dermatology Centers
Miami, Florida, United States, 33136
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Rush University
Chicago, Illinois, United States, 60612
United States, Louisiana
Tulane
New Orleans, Louisiana, United States, 70112
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
University of Minnesota Medical School
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Wake Forest University Health
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University Hospitals-Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt
Nashville, Tennessee, United States, 37206
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Institute At the University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: Mandeep Kaur, MD Valeant Pharmaceutical NA
  More Information

No publications provided

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT01007448     History of Changes
Other Study ID Numbers: E7273-G000-401
Study First Received: November 3, 2009
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Valeant Pharmaceuticals International, Inc.:
CTCL
bexarotene
Targretin
Refractory Cutaneous T-cell Lymphoma
cutaneous T-cell Lymphoma
MF
Mycoses fungoides

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Bexarotene
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014