PURPOSE: This study is designed to determine the recommended dose, safety, pharmacokinetics, and early efficacy of the combination of pralatrexate plus oral bexarotene in patients with relapsed or refractory CTCL.
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Conditions: Lymphomas-Non-Hodgkin; Lymphomas-Non-Hodgkin-Cutaneous T-Cell Lymphoma; Lymphomas-Non-Hodgkin-Peripheral T-Cell Lymphoma
Health of Volunteers: People with the conditions listed in this trial can participate as controls.
* Cutaneous T-cell lymphoma patients with subtypes of mycosis fungoides (MF) Stage IIB or higher, Sézary syndrome, or primary cutaneous anaplastic large cell lymphoma who have failed a previous systemic treatment.
* Relapse or progression of disease (PD) after at least 1 previous systemic therapy. The patient should have either progressed or not tolerated their last prior treatment regimen, and have recovered from the toxic effects of prior therapy. Patients treated with an FDA-approved monoclonal antibody therapy may be enrolled at any time after therapy if they have PD.
* Eastern Cooperative Oncology Group Performance Status less than or equal to 2.
* Adequate blood, liver, and kidney function as defined by laboratory tests.
* Patient has taken 1-1.25 mg of oral folic acid daily for at least 7 days and received 1 mg of vitamin B12 intramuscularly within 10 weeks prior to the planned start of pralatrexate.
* Women of childbearing potential must practice medically acceptable contraception from study treatment start until at least 30 days after the last dose of study treatment. Must have a negative serum pregnancy test within 14 days before the first day of study treatment (not required for patients who are postmenopausal for at least 1 year or surgically sterilized). Study treatment should not be given to women who are breastfeeding.
* Men who are not surgically sterile must agree to practice medically acceptable contraception from study treatment start until at least 90 days after the last dose of study treatment.
* Give written informed consent & privacy authorization.
* If there is a history of prior malignancies other than non melanoma skin cancer, carcinoma in situ of the cervix, localized prostate cancer, or localized thyroid cancer, patient must be disease free for at least 5 years. Patients with other prior malignancies less than 5 years before study entry may be enrolled if they have received treatment resulting in complete resolution of the cancer and currently have no clinical, radiologic, or laboratory evidence of active or recurrent disease.
* MF with large cell transformation (greater than 25% of large cells).
* Human immunodeficiency virus (HIV)-positive diagnosis with a CD4 count of less than 100 mm3 or detectable viral load within the past 3 months, and receiving combination anti-retroviral therapy.
* Hepatitis B or C virus diagnosis with detectable viral load or immunological evidence of chronic active disease or receiving/requiring antiviral therapy.
* Active central nervous system disease requiring treatment.
* Active uncontrolled infection, underlying medical condition, or other serious illness that would impair the patient's ability to receive protocol treatment.
* Major surgery within 2 weeks of planned start of treatment.
* Conventional or investigational chemotherapy or radiation therapy encompassing greater than 10% of bone marrow within 4 weeks prior to study treatment.
* Extracorporeal phototherapy (ECP), phototherapy with oral psoralen and ultraviolet A (PUVA), or ultraviolet (UV) therapy within 2 weeks prior to study treatment.
* Systemic corticosteroids within 3 weeks of study treatment, unless patient has been taking a continuous dose of no more than 10 mg per day of prednisone for at least 1 month.
* Initiation of or change in dosage of topical corticosteroids within 3 weeks of study treatment (topical steroid use within 3 weeks is allowed provided the strength and use has been stable for at least 1 month).
* Investigational drugs, biologics, or devices use within 2 weeks prior to study treatment or planned use during the study.
* Monoclonal antibody within 3 months without evidence of PD.
* Oral retinoids use within 4 weeks of study treatment or high-dose vitamin A (once daily multi-vitamin allowed).
* Previous exposure to pralatrexate or bexarotene.
* Uncontrolled hypercholesterolemia or hypertriglyceridemia.
CLINICALTRIALS.GOV IDENTIFIER: NCT01134341
Stanford University School of Medicine, Stanford, CA , United States
Cutaneous Lymphoma Coordinator, 650.421.6370
Principal Investigator: Youn H. Kim, M.D.
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