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.
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
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.
- First posted27 Jan 2003 (estimated)
- Study startFeb 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Millennix
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joan Guitart, MD, Study chair, Robert H. Lurie Cancer Center
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Muliticenter, Dose-Reandomized Evaluation Of Targretin Capsules Plus PUVA In Patients With Stage IB - IIA Cutaneous T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00030589
- Acronym / sponsor ID
- CDR0000069179
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- MillennixIndustry (pharma, biotech, devices)
- Study start
- Feb 2001
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bexarotene | Drug | – |
| methoxsalen | Drug | – |
| UV light therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
- Derived from this study: PubMed 32632956Valipour 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan Guitart, MD study chair
Robert H. Lurie Cancer Center
19 sites in 1 country: see every site and its status.
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.