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Birmingham, Alabama 35294

  • Lymphoma

Purpose:

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.


Study summary:

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.


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)


Study is Available At:


Original ID:

CDR0000069179


NCT ID:

NCT00030589


Secondary ID:

MILL-61896


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Active, not recruiting


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Masking: Open Label, Prima


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Joan Guitart, MD
Study Chair
Robert H. Lurie Cancer Center

Study Dates

Start Date:February 2001
Verification Date:October 2003
Last Changed Date:December 17, 2013
First Received Date:February 14, 2002

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:bexarotene
Intervention Type:Drug
Name:methoxsalen
Intervention Type:Procedure
Name:UV light therapy

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Millennix

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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