Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma

Lymphoma Clinical Trial

Official title:

A Muliticenter, Dose-Reandomized Evaluation Of Targretin Capsules Plus PUVA In Patients With Stage IB - IIA Cutaneous T-Cell Lymphoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00030589
• Other study ID #: CDR0000069179
• Secondary ID: MILL-61896LIGAND
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 14, 2002
• Last updated: December 17, 2013
• Start date: February 2001

Study information

• Verified date: October 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill cancer cells. Photosensitizing drugs, such as methoxsalen, are absorbed by cancer cells and, when exposed to light, become active and kill the cancer cells. Combining chemotherapy with photodynamic therapy may be an effective treatment for cutaneous T-cell lymphoma.

PURPOSE: Randomized phase II trial to study the effectiveness of combining different doses of bexarotene with photodynamic therapy in treating patients who have stage IB or stage IIA cutaneous T-cell lymphoma.

Description:

OBJECTIVES:

• Compare the efficacy of 2 different doses of bexarotene administered with ultraviolet A light therapy with methoxsalen (PUVA) in patients with stage IB or IIA cutaneous T-cell lymphoma.

• Compare the safety of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one of two treatment arms.

• Arm I: Patients receive a lower dose of oral bexarotene once daily on weeks 1-26. Patients also receive ultraviolet A light therapy with oral methoxsalen 3 times weekly on weeks 2-26.

• Arm II: Patients receive a higher dose of oral bexarotene once daily on weeks 1-26. Patients also receive ultraviolet A light therapy as in arm I.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed cutaneous T-cell lymphoma within the past year

• Stage IB or IIA disease

• No prior diagnosis more advanced than stage IIA disease

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Hemoglobin at least 9 g/dL

• WBC at least 2,000/mm^3

• Absolute lymphocyte count normal

Hepatic:

• Bilirubin less than 1.5 times upper limit of normal (ULN)

• AST and ALT no greater than 2.5 times ULN

• No significant hepatic dysfunction

Renal:

• Creatinine no greater than 2 times ULN

• Calcium no greater than 11.5 mg/dL

• No significant renal dysfunction

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for at least 1 month after study participation

• Fasting triglycerides normal (fenofibrate or another anti-lipemic agent allowed except gemfibrozil)

• HIV negative

• No other concurrent known serious medical illness or infection that would preclude study participation

• No prior uncontrolled hyperlipidemia

• No pancreatitis or clinically significant risk factors for developing pancreatitis

• No known allergy or sensitivity to retinoid class drugs or fenofibrate or idiosyncratic reactions to psoralen compounds

• No history of light-sensitive disease states (e.g., lupus, porphyria, or albinism) or aphakia

• No prior or concurrent melanoma or invasive squamous cell carcinoma

• No pre-existing gallbladder disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior systemic anticancer interferon

• No prior systemic anticancer denileukin diftitox

Chemotherapy:

• At least 30 days since prior topical anticancer carmustine or mechlorethamine

• No prior systemic anticancer alkaloid chemotherapy

• No other concurrent systemic or topical anticancer chemotherapy (e.g., methotrexate or cyclophosphamide)

Endocrine therapy:

• At least 30 days since prior topical anticancer corticosteroids

• No concurrent systemic or topical anticancer corticosteroids

Radiotherapy:

• No concurrent localized radiotherapy to specific study lesions except at investigator's discretion

Surgery:

• Not specified

Other:

• No prior systemic anticancer therapy

• At least 30 days since prior topical anticancer therapy (e.g., ultraviolet B light or psoralen-ultraviolet-light therapy)

• At least 30 days since prior participation in another investigational drug study

• At least 30 days since prior vitamin A (at doses of more than 15,000 IU/day) or other retinoid class drugs

• No other concurrent systemic or topical anticancer drugs or therapies

• No other concurrent systemic retinoid class drugs, beta-carotene compounds, or vitamin A (at doses of more than 15,000 IU/day)

• No other concurrent investigational medication

• No concurrent gemfibrozil

• No concurrent statin class anti-lipemics combined with fibrate class anti-lipemics (e.g., atorvastatin with fenofibrate)

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous

Intervention

Drug:
• bexarotene

• methoxsalen

Procedure:
• UV light therapy

Locations

Country	Name	City	State
United States	University of Colorado Health Science Center	Aurora	Colorado
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Boston Medical Center	Boston	Massachusetts
United States	Northwestern University Medical Center	Chicago	Illinois
United States	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Simmons Cancer Center - Dallas	Dallas	Texas
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Henry Ford Hospital	Detroit	Michigan
United States	StonyBrook Dermatology Associates, P.C.	East Setauket	New York
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Knoxville Dermatology Group, P.C.	Knoxville	Tennessee
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	St. Luke's-Roosevelt Hospital Center - Roosevelt Division	New York	New York
United States	Stanford University Medical Center	Stanford	California
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Millennix

Country where clinical trial is conducted

United States,