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

Sponsor

Millennix (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00030589

Collaborator

(none)

Locations

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: bexarotene Drug: methoxsalen Procedure: UV light therapy	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2001

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama	United States	35294-3300
2	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
3	Stanford University Medical Center	Stanford	California	United States	94305
4	University of Colorado Health Science Center	Aurora	Colorado	United States	80010-0510
5	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612-9497
6	Northwestern University Medical Center	Chicago	Illinois	United States	60611
7	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois	United States	60612
8	Tulane University School of Medicine	New Orleans	Louisiana	United States	70112
9		Slidell	Louisiana	United States	70459-0059
10	Boston Medical Center	Boston	Massachusetts	United States	02118-2393
11	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201-1379
12	Henry Ford Hospital	Detroit	Michigan	United States	48202
13	StonyBrook Dermatology Associates, P.C.	East Setauket	New York	United States	11733
14	St. Luke's-Roosevelt Hospital Center - Roosevelt Division	New York	New York	United States	10019
15	Ireland Cancer Center	Cleveland	Ohio	United States	44106-5065
16	Knoxville Dermatology Group, P.C.	Knoxville	Tennessee	United States	37920
17	Simmons Cancer Center - Dallas	Dallas	Texas	United States	75235-9154
18	University of Texas - MD Anderson Cancer Center	Houston	Texas	United States	77030-4009
19		Tyler	Texas	United States	75703