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|NCT01716468 : Ketogenic Diet in Advanced Cancer|
|Ages||Min: 18 Years Max: N/A|
Subjects must meet all of the following criteria to be eligible for the study:
- 18 years of age or older.
- English speaking and written informed consent obtained.
- Patients presenting to the VAPHS Oncology inpatient or outpatient clinic with
cancer of advanced or metastatic stage.
- Must have measurable disease at least 1 cm in greatest diameter on CT or MRI
scanning. If a new FDG avid satellite lesions are noted this will be counted as
disease progression. The minimum size is 1 cm. The tumor will be measured at the
longest diameter. Either the primary tumor or metastatic tumor, either may be used.
In absence of primary tumor, we usually measure the next largest metastatic lesion.
The tumor will be chose by using RECIST criteria measure (at the screening visit)
tumors, then using the 4 response criteria, CR complete response= disappearance of
all target lesions, PR= 30% decrease in the sum of the longest diameter of target
lesions, PD progressive disease= 20% increase in the sum of the longest diameter of
target lesions, and SD stable disease= small changes that don't meet the above
- Patients must have solid, advanced or metastatic tumors, and have failed to respond
to chemotherapy or on chemotherapy holiday.
- Tumors must be PET positive in primary or metastatic site.
- Patients must not be actively receiving chemotherapy after holiday or have refused
or failed one or more prior chemotherapy or radiotherapy treatment.
- Subjects may be enrolled in any other studies as long as they are not under an active
form of chemotherapy or radiotherapy intervention.
- No subjects will be excluded based on their race, religion, ethnicity, and gender or
HIV status, as applicable.
- Prisoners or subjects who are involuntarily incarcerated.
- Secondary brain metastases.
- History of Gout.
- AST or ATL > 1.5 X ULN.
- Creatinine > 2.0.
- Hematologic malignancies
- BMI < 22.
- History of kidney disease or kidney stones.
- Receiving chemotherapy including biologics.
- Recent AMI/TIA or stroke within one month of study entry.
- ECOG performance status of 3 or worse.
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