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.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • dietary supplement : Folic Acid
  • dietary supplement : Vitamin B12
  • drug : Pralatrexate Injection
  • drug : Bexarotene Capsules

Phase: Phase 1

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- Cutaneous T-cell lymphoma patients with subtypes of mycosis fungoides (MF) Stage IB or higher, SÚzary 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.

External Links

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Contact information

Primary Contact:

Cutaneous Lymphoma Coordinator 6504216370

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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