Study of Pralatrexate With Vitamin B12 and Folic Acid Supplementation for Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)

• Status: Completed
• Trial end date: 2014-04-01

Summary

The purpose of this study is to find out if the experimental drug pralatrexate with the vitamins folic acid and vitamin B12 might be an effective treatment for head and neck cancer. The reason we are doing this study is because another drug called methotrexate has been used for a long time to treat head and neck cancer patients. Pralatrexate was designed by scientists to be a new drug that works better than methotrexate. Laboratory studies have shown that pralatrexate works better than methotrexate at killing cancer cells.

Pralatrexate has already been studied in patients with other types of cancers, such as lymphoma and lung cancer. The results from those studies were promising. Pralatrexate was recently approved by the Food and Drug Administration (FDA) as a new treatment for a cancer called peripheral T cell lymphoma.

• Phase: Phase 2

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: National Comprehensive Cancer Network; New York University Cancer Institute; New York University School of Medicine; NYU Langone Health
• Treatments: Aminopterin; Folic Acid; Hydroxocobalamin; Vitamin B 12; Vitamin B Complex; Vitamins