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A Phase I/IIA Study of Pralatrexate and Gemcitabine with Vitamin B12 and Folic Acid Supplementation in Patients with Relapsed or Refractory Lymphoma
[Protocol 07-062]
- Full Title :
- A PHASE 1/2A OPEN-LABEL STUDY OF PRALATREXATE AND GEMCITABINE WITH VITAMIN B12 AND FOLIC ACID SUPPLEMENTATION IN PATIENTS WITH RELAPSED OR REFRACTORY LYMPHOPROLIFERATIVE MALIGNANCIES
- Purpose :
The purpose of this study is to find the highest dose of pralatrexate and gemcitabine that can be safely given together with vitamin B12 and folic acid supplementation in patients with lymphoma that has either returned despite prior treatment or is no longer responding to therapy.
Pralatrexate is an investigational drug that works in a way similar to methotrexate, a chemotherapy drug used for many years to treat various types of cancer. Pralatrexate blocks the way cancer cells divide and multiply, which can result in death of the cancer cells. In this way, pralatrexate can slow or stop the growth of the tumor, or decrease the size of the tumor. In laboratory tests, pralatrexate appears to be more effective than methotrexate and other related drugs in killing cancer cells. Giving vitamin B12 and folic acid along with this drug may reduce any side effects.
Gemcitabine is another type of chemotherapy drug. It has been approved for treating pancreatic, lung, ovarian, and breast cancers. Its use for treating lymphomas is considered investigational.
Laboratory studies have suggested that combining pralatrexate with gemcitabine may increase the effectiveness of the two drugs in a synergistic manner. Early clinical trials also showed that each drug alone had some activity against lymphomas. These findings provide the rationale for assessing the two drugs together in patients.
- 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 Hodgkin's or non-Hodgkin's lymphoma that persists or has progressed despite at least one prior regimen of therapy.
- At least 4 weeks must have passed since prior chemotherapy or radiation therapy and 2 weeks since any major surgery 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 at least 18 years of age.
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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