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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
Est. completion date
Est. primary completion date
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


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, 

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