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| ID | Type | Description | Link |
|---|---|---|---|
| MSKCC-01128 | |||
| NCI-G01-2049 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant interferon alfa | Biological | |||
| bexarotene | Drug |
DISEASE CHARACTERISTICS:
Histologically confirmed cutaneous T-cell lymphoma
Measurable or assessable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| David J. Straus, MD | Memorial Sloan Kettering Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States | ||
| NYU School of Medicine's Kaplan Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17366595 | Result | 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. |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D016898 | Interferon-alpha |
| D000077610 | Bexarotene |
| ID | Term |
|---|---|
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
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| New York |
| New York |
| 10016 |
| United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| Abramson Cancer Center of the University of Pennsylvania Medical Center | Philadelphia | Pennsylvania | 19104-4283 | United States |
| University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |