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Bexarotene and Interferon Alfa in Treating Patients With Cutaneous T-Cell Lymphoma

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
recombinant interferon alfa
bexarotene
Sponsored by
Memorial Sloan Kettering Cancer Center
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, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed cutaneous T-cell lymphoma Stage IB, IIA, IIB, III, or IV Measurable or assessable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Hemoglobin at least 9 g/dL WBC at least 1,500/mm^3 Platelet count at least 70,000/mm^3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT and SGPT no greater than 3 times upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN Fasting triglyceride normal (normalization with an antilipemic agent is allowed prior to study) No severe decompensated liver disease (e.g., cirrhosis, autoimmune hepatitis, or any other significant liver dysfunction) Renal: Calcium no greater than 11.5 mg/dL Creatinine no greater than 2 times ULN Cardiovascular: No myocardial infarction in the past 6 months No unstable angina No class III or IV congestive heart failure No ventricular tachyarrhythmias Pulmonary: No pulmonary infiltrates or clinical pulmonary impairment Other: HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 forms of effective contraception for 1 month before, during, and for 1 month after study therapy No known allergy or sensitivity to interferon alfa or bexarotene or other components of study drugs No uncontrolled thyroid disorder No other concurrent serious medical illness that would preclude study No infection No history of pancreatitis No history of neuropsychiatric disorders requiring hospitalization No history of autoimmune disease that would pose significant risk Must be willing and able to avoid prolonged exposure to the sun or ultraviolet light PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent systemic anticancer chemotherapy Endocrine therapy: No concurrent systemic corticosteroids Radiotherapy: No concurrent localized radiotherapy to target lesions unless considered to have shown progressive disease Surgery: Not specified Other: At least 30 days since prior systemic doses of more than 15,000 IU per day of vitamin A or any other retinoid class drug At least 30 days since prior participation in any other investigational drug study No concurrent systemic anti-psoriatic drugs or therapies No concurrent systemic other anticancer drugs or therapies No concurrent gemfibrozil No other concurrent investigational medication

Sites / Locations

  • University of Miami Sylvester Comprehensive Cancer Center
  • NYU School of Medicine's Kaplan Comprehensive Cancer Center
  • Memorial Sloan-Kettering Cancer Center
  • Abramson Cancer Center of the University of Pennsylvania Medical Center
  • University of Texas - MD Anderson Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 14, 2002
Last Updated
April 2, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00030849
Brief Title
Bexarotene and Interferon Alfa in Treating Patients With Cutaneous T-Cell Lymphoma
Official Title
Phase II Trial Of Oral Bexarotene (Targretin) Combined With Interferon Alfa-2b (Intron-A) For Patients With Cutaneous T-Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

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. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining bexarotene with interferon alfa in treating patients who have cutaneous T-cell lymphoma.
Detailed Description
OBJECTIVES: Determine the response rate and response duration in patients with cutaneous T-cell lymphoma when treated with bexarotene and, in the absence of a complete response, interferon alfa. Determine the safety and toxicity in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral bexarotene once daily for 8 weeks. Patients with a complete response (CR) after 8 weeks continue bexarotene alone for at least another 8 weeks in the absence of unacceptable toxicity. Patients who progress or relapse during bexarotene therapy or who achieve less than a CR after 8 weeks begin receiving interferon alfa subcutaneously 3 times a week and oral bexarotene daily for at least another 8 weeks in the absence of continuing disease progression or unacceptable toxicity. Patients are followed at 4 weeks. PROJECTED ACCRUAL: A total of 20-45 patients will be accrued for this study within 2 years.

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, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa
Intervention Type
Drug
Intervention Name(s)
bexarotene

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 Stage IB, IIA, IIB, III, or IV Measurable or assessable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Hemoglobin at least 9 g/dL WBC at least 1,500/mm^3 Platelet count at least 70,000/mm^3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT and SGPT no greater than 3 times upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN Fasting triglyceride normal (normalization with an antilipemic agent is allowed prior to study) No severe decompensated liver disease (e.g., cirrhosis, autoimmune hepatitis, or any other significant liver dysfunction) Renal: Calcium no greater than 11.5 mg/dL Creatinine no greater than 2 times ULN Cardiovascular: No myocardial infarction in the past 6 months No unstable angina No class III or IV congestive heart failure No ventricular tachyarrhythmias Pulmonary: No pulmonary infiltrates or clinical pulmonary impairment Other: HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 forms of effective contraception for 1 month before, during, and for 1 month after study therapy No known allergy or sensitivity to interferon alfa or bexarotene or other components of study drugs No uncontrolled thyroid disorder No other concurrent serious medical illness that would preclude study No infection No history of pancreatitis No history of neuropsychiatric disorders requiring hospitalization No history of autoimmune disease that would pose significant risk Must be willing and able to avoid prolonged exposure to the sun or ultraviolet light PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent systemic anticancer chemotherapy Endocrine therapy: No concurrent systemic corticosteroids Radiotherapy: No concurrent localized radiotherapy to target lesions unless considered to have shown progressive disease Surgery: Not specified Other: At least 30 days since prior systemic doses of more than 15,000 IU per day of vitamin A or any other retinoid class drug At least 30 days since prior participation in any other investigational drug study No concurrent systemic anti-psoriatic drugs or therapies No concurrent systemic other anticancer drugs or therapies No concurrent gemfibrozil No other concurrent investigational medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J. Straus, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Miami Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
NYU School of Medicine's Kaplan Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Abramson Cancer Center of the University of Pennsylvania Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
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

12. IPD Sharing Statement

Citations:
PubMed Identifier
17366595
Citation
Straus DJ, Duvic M, Kuzel T, Horwitz S, Demierre MF, Myskowski P, Steckel S. Results of a phase II trial of oral bexarotene (Targretin) combined with interferon alfa-2b (Intron-A) for patients with cutaneous T-cell lymphoma. Cancer. 2007 May 1;109(9):1799-803. doi: 10.1002/cncr.22596.
Results Reference
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Bexarotene and Interferon Alfa in Treating Patients With Cutaneous T-Cell Lymphoma

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