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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

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


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Joan Guitart, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069179

NCT ID:

NCT00030589

Start Date:

February 2001

Completion Date:

Related Keywords:

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

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Stanford University Medical CenterStanford, California  94305-5408
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Ireland Cancer CenterCleveland, Ohio  44106-5065
Simmons Cancer Center - DallasDallas, Texas  75235-9154
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Henry Ford HospitalDetroit, Michigan  48202
Tulane University School of MedicineNew Orleans, Louisiana  70112
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Boston Medical CenterBoston, Massachusetts  02118
Northwestern University Medical CenterChicago, Illinois  60611
St. Luke's-Roosevelt Hospital Center - Roosevelt DivisionNew York, New York  10019
Austin, Texas  78705
Metairie, Louisiana  70006
University of Colorado Health Science CenterAurora, Colorado  80010-0510
StonyBrook Dermatology Associates, P.C.East Setauket, New York  11733
Knoxville Dermatology Group, P.C.Knoxville, Tennessee  37920