N2012-01: Phase 1 Study of Difluoromethylornithine (DFMO) and Celecoxib With Cyclophosphamide/Topotecan

Official Title

N2012-01: Phase 1 Study of Difluoromethylornithine (DFMO) and Celecoxib With Cyclophosphamide/Topotecan for Patients With Relapsed or Refractory Neuroblastoma

Summary:

This study will combine an oral drug called DFMO with celecoxib (also oral) and two IV chemotherapy medicines called cyclophosphamide and topotecan. - To find the highest dose of DFMO that can be given with celecoxib, cyclophosphamide and topotecan without causing severe side effects. - To find out the side effects seen by giving DFMO at different dose levels with celecoxib, cyclophosphamide and topotecan. - To measure the levels of DFMO in the blood at different dose levels. - To determine if your tumour gets smaller after treatment with DFMO, celecoxib, cyclophosphamide and topotecan. - To determine if specific gene changes in you or your tumour makes you more prone to side effects or affects your tumour's response to the combination of DFMO, celecoxib, cyclophosphamide and topotecan. - To determine if the amount of normal chemicals in your body called polyamines go down in response to DFMO, celecoxib, cyclophosphamide and topotecan, and whether you are more likely to have a good response to the treatment if they do.

Trial Description

Primary Outcome:

• Number of participants with adverse events as a measure of safety and tolerability.

View this trial on ClinicalTrials.gov