Pralatrexate and Bexarotene in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma



Status:Recruiting
Conditions:Infectious Disease, Lymphoma
Therapuetic Areas:Immunology / Infectious Diseases, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/30/2013
Start Date:March 2010
Contact:Lacey Chance
Phone:1-888-255-6702

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A Phase 1, Open-label, Dose-finding Study of Pralatrexate Plus Systemic Bexarotene in Patients With Relapsed or Refractory Cutaneous T Cell Lymphoma


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.


Inclusion Criteria:

- Cutaneous T-cell lymphoma patients with subtypes of mycosis fungoides (MF) Stage IB
or higher, Sézary syndrome, or primary cutaneous anaplastic large cell lymphoma who
have failed a previous systemic treatment.

- Patients must have received at least 1 previous systemic therapy, and either
progressed or not tolerated their last prior treatment regimen.

- Eastern Cooperative Oncology Group Performance Status less than or equal to 2.

- Adequate blood, liver, and kidney function as defined by laboratory tests.

- 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.
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.

- Males who are sexually active must agree to practice medically acceptable barrier
contraception while receiving study treatment and for 30 days after the last dose of
study treatment.

- Give written informed consent & privacy authorization.

Exclusion Criteria:

- 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 received
treatment resulting in complete resolution of the cancer and have no current
clinical, radiologic, or laboratory evidence of active or recurrent disease.

- 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.

- Diagnosis of Hepatitis B virus, or Hepatitis C virus 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
impairing the patient's ability to receive protocol treatment.

- Discontinuation of prior oral bexarotene due to an allergic reaction or
treatment-related toxicity.

- 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.

- ECP, phototherapy with 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 or equivalent
for at least 4 weeks.

- 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 4 weeks).

- 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.

- Use of oral retinoids, except bexarotene, within 4 weeks of study treatment or
high-dose vitamin A (once daily multi-vitamin allowed).

- Previous exposure to pralatrexate.

- Uncontrolled hypercholesterolemia or hypertriglyceridemia.
We found this trial at
6
sites
333 Cottman Ave
Philadephia, Pennsylvania 19111
(215) 728-6900
Fox Chase Cancer Center Fox Chase has earned the prestigious designation from the National Cancer...
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Philadephia, PA
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1275 York Avenue
New York, New York 10065
212-639-2000
Memorial Sloan-Kettering Cancer Center Memorial Sloan-Kettering Cancer Center — the world's oldest and largest private...
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New York, NY
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291 Campus Dr
Stanford, California 94305
(650) 725-3900
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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Stanford, CA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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Pittsburgh, Pennsylvania 15261
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Pittsburgh, PA
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