CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
Pralatrexate With Vitamin B12 and Folic Aciddrug
Likely dose
Pralatrexate With Vitamin B12 and Folic Acid 30 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01183065
NCT01183065Phase 2Completed
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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)

Memorial Sloan Kettering Cancer Center·interventional·Posted Aug 17, 2010·Updated Nov 20, 2015

In Brief

A Phase 2 clinical trial evaluating Pralatrexate With Vitamin B12 and Folic Acid for Head and Neck Cancer. Completed, enrolled 13 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer
CountriesUnited States
CollaboratorsNew York University Cancer Institute, NYU Langone Health, National Comprehensive Cancer Network

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 17, 2010
Enrollment StartAug 1, 2010
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 15.9 years ago

Interventions

Pralatrexate With Vitamin B12 and Folic Aciddrug

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.