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LymphomaPhase 2NCT00030589

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

A Phase 2 study testing bexarotene, methoxsalen and UV light therapy in people with Lymphoma, run by Millennix at 19 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
bexarotene, methoxsalen and UV light therapy
Type of treatment
Surgery or procedure
How many people
Not given
Where
19 sitesUnited States
Study dates
Feb 2001to not given
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites
  • University of Colorado Health Science Center

    Aurora, Colorado, 80010-0510

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35294-3300

  • Boston Medical Center

    Boston, Massachusetts, 02118-2393

  • Northwestern University Medical Center

    Chicago, Illinois, 60611

  • Rush-Presbyterian-St. Luke's Medical Center

    Chicago, Illinois, 60612

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • Simmons Cancer Center - Dallas

    Dallas, Texas, 75235-9154

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • StonyBrook Dermatology Associates, P.C.

    East Setauket, New York, 11733

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Knoxville Dermatology Group, P.C.

    Knoxville, Tennessee, 37920

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • St. Luke's-Roosevelt Hospital Center - Roosevelt Division

    New York, New York, 10019

  • Study site

    Slidell, Louisiana, 70459-0059

  • Stanford University Medical Center

    Stanford, California, 94305

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612-9497

  • Study site

    Tyler, Texas, 75703

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Lymphoma
Being tested
bexarotene, methoxsalen, UV light therapy
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
Medical subject headings
Lymphoma, Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bexaroteneDrug

  • methoxsalenDrug

  • UV light therapyProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startFeb 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00030589
Sponsor's protocol ID
CDR0000069179
Other IDs
MILL-61896, LIGAND-MILL-61896, NU-IRB-837-002
Status last verified
Oct 2003
First submitted
14 Feb 2002
Last updated
18 Dec 2013
Results posted
No

Publications

  • 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.

    PubMed 32632956

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bexarotene, methoxsalen and UV light therapy in people with Lymphoma, run by Millennix at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00030589, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013.

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