Study of Pralatrexate to Treat Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder

What Was Tested

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

The study will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this patient population.

It had 1 arm (groups): Dietary Supplement Vitamin B12 & Folic Acid (Vitamin B9) (other).

The registry classes the interventions as dietary supplement and drug.

Who Took Part

Enrollment: 30 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: Histologically confirmed transitional cell carcinoma of the urinary bladder. Fine needle aspirate will not be accepted. Measurable disease outside a previously irradiated region, per Response Evaluation Criteria in Solid Tumors (RECIST). Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. At least 18 years of age. Adequate blood, liver, and kidney function as defined by laboratory results.

The full record lists 11 inclusion and 14 exclusion criteria; among the exclusions: more than 1 previous regimen for recurrent/metastatic disease; use of investigational drugs, biologics, or devices within 28 days prior to study enrollment; previous exposure to other antifolates, including pralatrexate. previous methotrexate is allowed, only if it was part of an m-vac or mcv regimen.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Cyanocobalamin (Vitamin B12) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2008-07 with completion listed for 2011-04.

It ran at 19 sites in France (5), United States (4), Croatia (3), Spain (3), Argentina (2) and Belgium (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Objective Response Rate (ORR).

It also tracked 4 secondary outcomes, for example Duration of Response (DOR), Progression Free Survival (PFS) and Overall Survival (OS).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Cyanocobalamin (Vitamin B12) in 30 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.