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

NCT00306969 | Completed Phase 1

• 1 other identifier: 2001-391G
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cutaneous T-Cell Lymphoma

Keywords

mycosis fungoides, Sézary Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Interventions

bexarotene DRUG

photopheresis DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have biopsy-proven CTCL. Stages of CTCL IIA or greater are eligible.
• 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.
• Patients previously treated with photopheresis will be eligible
• 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
• Measurable or evaluable disease.
• Median life expectancy at least three months
• Females of child bearing potential must consent to the use of 2 forms of reliable contraceptives, one of which must be non-hormonal.
• All patients must provide written informed consent.
• Patients must have completed any prior treatment at least 2 weeks before enrollment.
• No concomitant medications for CTCL, including no topical steroids
• 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.
• No history of myocardial infarction within six months, no history of unstable angina or unstable blood pressure
• No oral or topical retinoid therapy within 1 month of entry in the study.
• No history of pancreatitis or pancreatic disease or surgery
• Fasting serum triglyceride within normal limits or "normalized" prior to study entry with appropriate intervention such as the use of an antilipid agent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead
• Ligand Pharmaceuticals: collaborator

Study Sites (1)

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (3)

• Duvic M, Martin AG, Kim Y, Olsen E, Wood GS, Crowley CA, Yocum RC; Worldwide Bexarotene Study Group. Phase 2 and 3 clinical trial of oral bexarotene (Targretin capsules) for the treatment of refractory or persistent early-stage cutaneous T-cell lymphoma. Arch Dermatol. 2001 May;137(5):581-93.

  PMID: 11346336 BACKGROUND

• Girardi M, Heald PW, Wilson LD. The pathogenesis of mycosis fungoides. N Engl J Med. 2004 May 6;350(19):1978-88. doi: 10.1056/NEJMra032810. No abstract available.

  PMID: 15128898 BACKGROUND

• Demierre MF, Ferzli P, Miller D. Measuring HRQOL in patients with cutaneous T-cell lymphoma undergoing therapy with oral bexarotene and extracorporeal photopheresis. Arch Dermatol. 2007 May;143(5):659-61. doi: 10.1001/archderm.143.5.659. No abstract available.

  PMID: 17515522 DERIVED

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides; Sezary Syndrome

Interventions

Bexarotene; Photopheresis

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; PUVA Therapy; Ultraviolet Therapy; Phototherapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Marie-France Demierre, MD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 23, 2006
• First Posted: March 27, 2006
• Study Start: December 1, 2001
• Study Completion: April 1, 2004
• Last Updated: March 27, 2006

Record last verified: 2004-09

Locations

US (1)