Clinical trial NCT00030589: Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma
Official title: A Muliticenter, Dose-Reandomized Evaluation Of Targretin Capsules Plus PUVA In Patients With Stage IB - IIA Cutaneous T-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lymphoma
Keywords: stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
stage I mycosis fungoides/Sezary syndrome
stage II mycosis fungoides/Sezary syndrome
recurrent mycosis fungoides/Sezary syndrome
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Comprehensive Cancer Center
state: Alabama
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Health Science Center
state: Colorado
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Chicago
country: United States
facility: Northwestern University Medical Center
state: Illinois
city: Chicago
country: United States
facility: Rush-Presbyterian-St. Luke's Medical Center
state: Illinois
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
city: Slidell
country: United States
state: Louisiana
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: East Setauket
country: United States
facility: StonyBrook Dermatology Associates, P.C.
state: New York
city: New York
country: United States
facility: St. Luke's-Roosevelt Hospital Center - Roosevelt Division
state: New York
city: Cleveland
country: United States
facility: Ireland Cancer Center
state: Ohio
city: Knoxville
country: United States
facility: Knoxville Dermatology Group, P.C.
state: Tennessee
city: Dallas
country: United States
facility: Simmons Cancer Center - Dallas
state: Texas
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
city: Tyler
country: United States
state: Texas
Study officials:
affiliation: Robert H. Lurie Cancer Center
name: Joan Guitart, MD
role: STUDY_CHAIR
References:
citation: Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.