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A Phase I Study of Pralatrexate with Vitamin B12 and Folic Acid Supplementation in Patients with Relapsed or Refractory Cutaneous T-cell Lymphoma
[Protocol 07-146]
- Full Title :
- PDX-010: A PHASE 1, OPEN-LABEL STUDY OF PRALATREXATE WITH VITAMIN B12 AND FOLIC ACID SUPPLEMENTATION IN PATIENTS WITH RELAPSED OR REFRACTORY CUTANEOUS T-CELL LYMPHOMA
- Purpose :
The purpose of this study is to evaluate an investigational drug, pralatrexate, in patients with cutaneous T-cell lymphoma (CTCL) that has returned despite or has stopped responding to standard therapies. Patients will also receive vitamin B12 and folic acid supplementation to help prevent the mouth sores experienced by some patients who have received pralatrexate.
Pralatrexate is in the same class of drugs as methotrexate, a chemotherapy drug that has been available for several decades, but it is far more potent. Pralatrexate blocks how cells are made, so the growth of the tumor can be slowed or stopped or the tumor size decreased.
Evidence from previous studies has been promising enough to lead to the US Food and Drug Administration granting orphan drug status and a fast-track approval process to pralatrexate for T-cell lymphoma. (An "orphan drug" refers to a product that treats a rare disease affecting fewer than 200,000 Americans.) Pralatrexate has been one of the most important drugs for T-cell lymphoma to be developed in a long time.
Because CTCL is a chronic disease, many people continue on treatments for long periods of time (months to years). In this study, doctors will lower the dose of pralatrexate used to treat other lymphomas to see if lower doses can still shrink CTCL while reducing or preventing as many side effects as possible.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of cutaneous T-cell lymphoma that has returned or has persisted despite at least one prior regimen of systemic therapy.
- At least 2 weeks must have passed since any major surgery and 4 weeks since prior chemotherapy or radiation therapy and entry into the study.
- Patients must not be confined to a bed or chair for more than half of their normal waking hours.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Steven M. Horwitz at 212-639-3045.
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