CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
DCA (dichloroacetate) +1 moredrug
Likely dose
DCA (dichloroacetate) 12.5mg/kgfrom 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/NCT01386632
NCT01386632Phase 2Completed
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Phase II Study of DCA (Dichloroacetate) in Combination With Cisplatin and Definitive Radiation in Stage III-IV Squamous Cell Carcinoma of the Head and Neck

Sanford Health·interventional·Posted Jul 1, 2011·Updated Oct 27, 2020

In Brief

A Phase 2 clinical trial evaluating DCA (dichloroacetate) and Placebo for Squamous Cell Carcinoma of the Head and Neck. Completed, enrolled 50 participants across 2 sites.

Detailed Summary

This will be a randomized masked placebo-controlled single-center study to evaluate the effects of Dichloroacetate (DCA) versus placebo given in combination with Cisplatin and radiation treatment in patients with Stage III-IV Squamous Cell Carcinoma of the Head and Neck (SCCHN). Fifty subjects will be enrolled and randomly assigned on a 1:1 ratio to DCA or matching placebo given with standard of care treatment consisting of Cisplatin and radiation treatment. Patients will receive DCA/placebo PO or per G-tube twice a day for 8 weeks. The first 6 patients of the total study population will represent a safety lead-in cohort. The results of the safety lead-in of DCA/placebo in combination with Cisplatin and radiation therapy will be evaluated after the 6th patient has completed 8 weeks of therapy. Recruitment of patients will be withheld during safety data analysis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSquamous Cell Carcinoma of the Head and Neck
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 1, 2011
Enrollment StartMay 1, 2011
Primary CompletionAug 1, 2014
Study CompletionJun 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 15.0 years ago

Interventions

DCA (dichloroacetate)drug

DCA orally 12.5mg/kg PO or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m\^2 IV over 30-60minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)

Placebodrug

Placebo PO or per G-tube twice a day for 8 weeks given in combination with Cisplatin.