Study of Pralatrexate With Vitamin B12 and Folic Acid Supplementation for Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)
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.
|Head and Neck Cancer||Drug: Pralatrexate With Vitamin B12 and Folic Acid||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multi-Institution Phase II Study of Pralatrexate With Vitamin B12 and Folic Acid Supplementation for Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)|
- To Determine the Overall Response Rate (CR+PR) [ Time Frame: 2 years ]by RECIST version 1.1 criteria
|Study Start Date:||August 2010|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Experimental: pralatrexate and vitamin supplementation
This will be an open-label, single arm, Simon optimal two-stage design phase II study.
Drug: Pralatrexate With Vitamin B12 and Folic Acid
Patients will be treated with 30 mg/m2 of pralatrexate intravenously once weekly for 3 weeks in a 4 week cycle with vitamin supplementation. Patients will take 1.0-1.25 mg oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of pralatrexate and dosing will be continued during the full course of therapy and for 30 days after the last dose of pralatrexate. Patients will also receive a vitamin B12 (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with pralatrexate.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01183065
|United States, New Jersey|
|Memoral Sloan Kettering Cancer Center|
|Basking Ridge, New Jersey, United States|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center @ Suffolk|
|Commack, New York, United States, 11725|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Memorial Sloan-Kettering at Mercy Medical Center|
|Rockville Centre, New York, United States|
|Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital|
|Sleepy Hollow, New York, United States|
|Principal Investigator:||Alan Ho, MD, PhD||Memorial Sloan Kettering Cancer Center|