Study of DCA (Dichloroacetate) in Combination With Cisplatin and Definitive Radiation in Head and Neck Carcinoma



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/25/2018
Start Date:May 2011
End Date:January 2019

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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

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.

Doses for Cisplatin will be based on actual body weight taken on each day of Cisplatin
therapy. DCA doses will be calculated at baseline according to actual body weight and will
not change during the 8 weeks of therapy.

A careful description of the extent of the primary lesion and nodal spread will be recorded.

Dental Evaluation: Prior to treatment, patients will be evaluated by the dental service and a
prophylactic cleaning/fluoride regimen instituted. A delay of at least 14 days from major
surgery, including dental extractions, will be required prior to Day 1 treatment.

Airway Patency: Significant laryngeal edema has been described after the use of cisplatin
containing regimens. Patients with laryngeal tumors should be considered for a prophylactic
tracheostomy prior to the initiation of chemotherapy, if any possibility of airway compromise
exists. Patients with laryngeal tumors experiencing respiratory stridor or compromise shortly
after chemotherapy/radiotherapy administration should be rapidly evaluated for tracheostomy.

Alimentation: Significant stomatitis, mucositis and dysphagia are expected with these
treatment regimens. Hospitalization may be required for symptomatic management. Pronounced
weight loss is common, and adequate alimentation needs to be maintained. Early, if not
pre-emptive, enteral tube feedings should be considered if difficulty is anticipated.

Compliance: The complexity of these treatment regimes and their attendant toxicity are such
that compliance is of major concern. Patients expected to pose compliance problems should not
be entered on this study. Patients will need to be seen at least weekly during therapy so
that the toxicities can be monitored and treated.

Inclusion Criteria:

- Patients must have histologically, cytologically confirmed and previously untreated
stage 3 or 4 HNSC that recommended treatment would be concurrent cisplatin and
radiation.

- Age ≥ 18 years

- ECOG performance status ≤ 2 or Karnofsky ≥70%

- Life expectancy of greater than 12 weeks.

- Patients must have normal organ and marrow function as defined below:

- Absolute neutrophil count ≥1,500/mcL

- Hemoglobin ≥90 g/L

- Platelets ≥100,000/mcL

- Total bilirubin ≤1.5 X upper limit of normal (ULN)

- AST(SGOT) and ALT(SGPT) ≤2.5 X ULN or ≤ 5 X ULN in the presence of liver
metastases

- Creatinine ≤1.5 X institutional upper limit of normal

- The effects of DCA on the developing human fetus are unknown. For this reason and
because DCA can be teratogenic, women of child-bearing potential and men must agree to
use adequate contraception (e.g.: hormonal or barrier method of birth control,
abstinence)prior to study entry and for the duration of study participation. Should a
woman become pregnant or suspect she is pregnant while participating in this study,
she should inform her treating physician immediately.

- Ability to understand the purpose of the study and the willingness to sign a written
informed consent document.

- Repeat biopsy is not mandatory, but is strongly suggested. Should be performed between
Day 8 and Day 15 treatments.

Exclusion Criteria:

- Patients may not be receiving any other investigational agents, chemotherapy,
immunotherapy, radiotherapy, or molecular targeted agents.

- Patients with known brain metastases should be excluded from this clinical trial
because of their poor prognosis and because they often develop progressive neurologic
dysfunction that could confound the evaluation of neurologic and other adverse events.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to DCA.(Cetuximab)

- Due to the possibility of peripheral sensorimotor neuropathy from DCA, the presence of
grade 2 or higher peripheral neuropathy due to a prior medical condition (such as
multiple sclerosis), medications, or other etiologies.

- Any psychological, familial, sociological, or geographical conditions that do not
permit medical follow-up and compliance with the study protocol.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, diabetes mellitus, or psychiatric illness/social situations that would
limit compliance with study requirements. Specifically, for patients who are taking
either or both oral hypoglycemics and insulin for diabetes mellitus will not be
eligible as DCA in combination with these agents may increase the risk of clinically
significant hypoglycemia, compromising patient safety.

- Pregnant or breast-feeding women are excluded from this study because DCA is an agent
with the potential for teratogenic or abortifacient effects. Because there is an
unknown but potential risk for adverse events in nursing infants secondary to
treatment of the mother with DCA, breastfeeding should be discontinued if the mother
is treated with DCA.

- HIV-positive patients on combination antiretroviral therapy are ineligible because of
the potential for pharmacokinetic interactions with DCA. In addition, these patients
are at increased risk of lethal infections when treated with marrow-suppressive
therapy.

- Five years must have elapsed since the initial curative procedure for other
malignancies, except for in situ cervical cancer, basal cell carcinoma of the skin,
and localized prostate cancer after curative therapy such as surgery, or radiation.

- History of malabsorption syndrome or substantial amount of small bowels or stomach
removed that may impair absorption of DCA.
We found this trial at
2
sites
Sioux Falls, South Dakota 57104
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from
Sioux Falls, SD
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Fargo, North Dakota 58122
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from
Fargo, ND
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