Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma
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| ClinicalTrials.gov Identifier: NCT00030589 |
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Recruitment Status : Unknown
Verified October 2003 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 18, 2013
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma | Drug: bexarotene Drug: methoxsalen Procedure: UV light therapy | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Allocation: | Randomized |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Muliticenter, Dose-Reandomized Evaluation Of Targretin Capsules Plus PUVA In Patients With Stage IB - IIA Cutaneous T-Cell Lymphoma |
| Study Start Date : | February 2001 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed cutaneous T-cell lymphoma within the past year
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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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030589
Show 19 study locations
| Study Chair: | Joan Guitart, MD | Robert H. Lurie Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00030589 |
| Other Study ID Numbers: |
CDR0000069179 MILL-61896 LIGAND-MILL-61896 NU-IRB-837-002 |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | December 18, 2013 |
| Last Verified: | October 2003 |
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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 |
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Lymphoma Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Lymphoma, Non-Hodgkin Bexarotene Methoxsalen Antineoplastic Agents Photosensitizing Agents Dermatologic Agents |