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| ID | Type | Description | Link |
|---|---|---|---|
| SU-05052010-5866 | Other Identifier | Stanford University | |
| ENT0031 | Other Identifier | OnCore |
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The purpose of this study is to study the effect of the drug DCA (dichloroacetate) on recurrent head and neck cancers. Part of this study will also use EF5 PET scan to study tumor hypoxia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dichloroacetate (DCA) | Experimental | 25 mg/kg/day, 37.5 mg/kg, or 50 mg/kg/day oral DCA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dichloroacetate | Drug | 25-50mg/kg per day; oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the maximum tolerated dose of DCA in patients with recurrent head and neck cancer who have failed first-line therapy. | Duration of study |
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Inclusion Criteria:
Pathologically confirmed head and neck squamous cell carcinoma
Age > 18 years old
Patients must have unresectable disease in which there is no accepted potentially curative treatment option
Patients must have acceptable organ and marrow function as defined below:
leukocytes >3,000/uL
absolute neutrophil count >1,500/uL
platelets >90,000/uL
total bilirubin <=1.5X normal institutional limits
AST(SGOT)/ALT(SGPT) <=2.5 X normal institutional limits with the following exceptions:
creatinine <=1.5X normal institutional limits OR creatinine clearance >50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation
Patients must have non-cranial gross disease that is greater than 1 cm on CT scan prior to enrollment
Disease must be FDG-avid on PET scanning
Creatinine within normal institutional limits
Eastern Clinical Oncology Group performance status 0, 1 or 2 (Appendix 1)
Life expectancy > 12 weeks
Both men and women and members of all races and ethnic groups are eligible for this trial.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel T Chang | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 20, 2015 | Jun 13, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003999 | Dichloroacetic Acid |
| ID | Term |
|---|---|
| D062845 | Chloroacetates |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| EF5 | Device | 21 mg/kg; IV |
|
|
| D009930 |
| Organic Chemicals |
| D006843 | Hydrocarbons, Chlorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |