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

What Was Tested

This registered phase 2 trial tested Cyanocobalamin (Vitamin B12).

Pralatrexate was designed by scientists to be a new drug that works better than methotrexate.

It had 1 arm (groups): pralatrexate and vitamin supplementation (experimental).

This will be an open-label, single arm, Simon optimal two-stage design phase II study.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 13 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients must be at least 18 years of age. ECOG performance status must be ≥ 0 or 1. Disease must be measurable by RECIST version 1.1 criteria. Patients must have been previously treated with systemic chemotherapy (i.e., chemotherapy and/or targeted therapies such as cetuximab for recurrent/metastatic HNSCC,. At least four weeks must have elapsed from previous radiation therapy. Patients must have recovered from the acute toxic effects of treatment prior to study enrollment.

The full record lists 9 inclusion and 4 exclusion criteria; among the exclusions: history of any brain metastases unless resected with no evidence for \> 12 weeks and not on steroids; women who are lactating; other active malignancy, other than indolent malignancies which the investigator determines are unlikely to interfere with treatment and safety analysis.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Cyanocobalamin (Vitamin B12) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2010-08 with completion listed for 2014-04.

It ran at 5 sites in United States (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: To Determine the Overall Response Rate (CR+PR) (time frame: 2 years).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Cyanocobalamin (Vitamin B12) in 13 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.