Study of Oral Bexarotene in Combination With Photopheresis for Treatment of Cutaneous T-Cell Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Ligand Pharmaceuticals
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT00306969
First received: March 23, 2006
Last updated: NA
Last verified: September 2004
History: No changes posted
  Purpose

This is a pilot study of the safety and tolerability of photopheresis in combination with increasing doses of oral bexarotene in patients with cutaneous T-cell lymphoma.Our hypotheses are that the combination of bexarotene with photopheresis is safe and that bexarotene will enhance immune response in the setting of extracorporeal photopheresis in the treatment of cutaneous T-cell lymphoma (CTCL), resulting in a shorter time to clinical response.


Condition Intervention Phase
Cutaneous T-Cell Lymphoma
Drug: bexarotene
Device: photopheresis
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Oral Bexarotene in Combination With Photopheresis for Treatment of Cutaneous T-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Safety and tolerability of bexarotene in combination with ECP, assessed with NCI toxicity assessment, at each treatment visit, every 3 weeks and at final one month foll

Secondary Outcome Measures:
  • Time to response of bexarotene with ECP in patients with CTCL, at month 4 (follow-up visit) patient’s response by organ system involvement, with an overall assessment: complete response, partial response, no change, or progressive disease, flare.
  • Another secondary outcome is whether combination of instruments provides relevant information on CTCL patients' health related quality of life during therapy

Estimated Enrollment: 18
Study Start Date: December 2001
Estimated Study Completion Date: April 2004
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have biopsy-proven CTCL. Stages of CTCL IIA or greater are eligible.
  2. Patients with stage IB, either resistant to 2 prior therapies, resistant to 1 prior therapy and intolerant to a second one, or intolerant to 2 prior therapies, will also be eligible.
  3. Patients previously treated with photopheresis will be eligible
  4. Patients previously treated with oral or topical bexarotene will be eligible –a 1 month wash out period will be required prior to entry into the study
  5. Measurable or evaluable disease.
  6. Median life expectancy at least three months
  7. Females of child bearing potential must consent to the use of 2 forms of reliable contraceptives, one of which must be non-hormonal.
  8. All patients must provide written informed consent.
  9. Patients must have completed any prior treatment at least 2 weeks before enrollment.
  10. No concomitant medications for CTCL, including no topical steroids
  11. Chronic topical steroid use is allowed if patients require low dose steroids for palliation of pruritus, but topical steroid therapy cannot be initiated after enrollment.
  12. No history of myocardial infarction within six months, no history of unstable angina or unstable blood pressure
  13. No oral or topical retinoid therapy within 1 month of entry in the study.
  14. No history of pancreatitis or pancreatic disease or surgery
  15. Fasting serum triglyceride within normal limits or “normalized” prior to study entry with appropriate intervention such as the use of an antilipid agent.

    • Cholesterol < 239 mg/dl
    • Triglyceride < 250 mg/dl
  16. Patients must have adequate renal, hepatic, cardiac function and hematologic values:

    • CBC :WBC>2000, HGB>9, Plt >30K.
    • Chemistry panel: Creatinine <2.5, LFTS <3x NL, albumin>2.5.
    • Absence of hepatic dysfunction characterized by SGOT (AST), SGPT (ALT), or serum bilirubin >3 times the upper limit of normal
  17. Women of child-bearing potential must have negative pregnancy test (serum *-HCG) with a sensitivity of at least 50 mIU within seven (7) days prior to the initiation of treatment and must have used effective contraception (recommended to be two reliable forms of contraception used simultaneously, at least one of which should be non-hormonal) or must have been sexually abstinent for at least four (4) weeks prior to the negative pregnancy test through entry in the study.

Exclusion Criteria:

The following patients are excluded:

  • inability to safely tolerate temporary removal of up to 750 ml of circulating blood due to poor vascular disease or labile blood pressure
  • pregnant, intent to become pregnant, or lactating females.
  • known hypersensitivity to bexarotene or other component of bexarotene capsules.
  • Risk factor for 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)
  • No systemic vitamin A in doses exceeding 15,000 IU/day within 14 days prior to initiating bexarotene
  • drug dependence or a psychiatric condition, which in the opinion of the investigator will interfere with participating in the study.
  • ECOG performance status of 3 or greater.
  • patients with known photosensitive disease.
  • allergy to psoralen.
  • patients with active uncontrolled infection.
  • patients currently participating in another investigational study.
  • patients with a systolic blood pressure £ 90 mmHg.
  • Patients who do not meet eligibility criteria for laboratory studies
  • Unwillingness or inability to minimize exposure to sunlight and artificial ultraviolet light while receiving bexarotene
  • Unwillingness to agree to sexual abstinence or to comply with effective contraception
  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: NCT00306969

Locations
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Ligand Pharmaceuticals
Investigators
Principal Investigator: Marie-France Demierre, MD Boston University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00306969     History of Changes
Other Study ID Numbers: 2001-391G
Study First Received: March 23, 2006
Last Updated: March 23, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Boston University:
mycosis fungoides, Sézary Syndrome

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 20, 2014