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

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston University
• Collaborator: Ligand Pharmaceuticals
• Treatments: Bexarotene

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