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

NCT00030849 | Completed Phase 2

• 3 other identifiers: CDR0000069202MSKCC-01128NCI-G01-2049
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Interventions

recombinant interferon alfa BIOLOGICAL

bexarotene DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Abramson Cancer Center of the University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Related Publications (1)

• 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.

  PMID: 17366595 RESULT

MeSH Terms

Conditions

Lymphoma; Lymphoma, T-Cell, Cutaneous

Interventions

Interferon-alpha; Bexarotene

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• David J. Straus, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 14, 2002
• First Posted: January 27, 2003
• Study Start: October 1, 2001
• Primary Completion: September 1, 2004
• Study Completion: December 1, 2009
• Last Updated: April 4, 2013

Record last verified: 2009-12

Locations

US (5)