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

Primary Purpose

Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bexarotene
methoxsalen
UV light therapy
Sponsored by
Millennix
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • University of Arkansas for Medical Sciences
  • Stanford University Medical Center
  • University of Colorado Health Science Center
  • H. Lee Moffitt Cancer Center and Research Institute
  • Northwestern University Medical Center
  • Rush-Presbyterian-St. Luke's Medical Center
  • Tulane University School of Medicine
  • Boston Medical Center
  • Barbara Ann Karmanos Cancer Institute
  • Henry Ford Hospital
  • StonyBrook Dermatology Associates, P.C.
  • St. Luke's-Roosevelt Hospital Center - Roosevelt Division
  • Ireland Cancer Center
  • Knoxville Dermatology Group, P.C.
  • Simmons Cancer Center - Dallas
  • University of Texas - MD Anderson Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 14, 2002
Last Updated
December 17, 2013
Sponsor
Millennix
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1. Study Identification

Unique Protocol Identification Number
NCT00030589
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2003
Overall Recruitment Status
Unknown status
Study Start Date
February 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Millennix

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bexarotene
Intervention Type
Drug
Intervention Name(s)
methoxsalen
Intervention Type
Procedure
Intervention Name(s)
UV light therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Guitart, MD
Organizational Affiliation
Robert H. Lurie Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado Health Science Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010-0510
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Northwestern University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush-Presbyterian-St. Luke's Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Tulane University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70459-0059
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118-2393
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
StonyBrook Dermatology Associates, P.C.
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
St. Luke's-Roosevelt Hospital Center - Roosevelt Division
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Knoxville Dermatology Group, P.C.
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Simmons Cancer Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-9154
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
City
Tyler
State/Province
Texas
ZIP/Postal Code
75703
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32632956
Citation
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.
Results Reference
derived

Learn more about this trial

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

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