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These initial 3 patients received 200mg hydroxychloroquine (HCQ) twice daily (400mg/day total) for 14 days prior to surgery.

Based on data analysis from the initial patients, these patients received 400mg hydroxychloroquine (HCQ) twice daily (800mg/day total) for 14 days prior to surgery.

Based on data from the primary and secondary groups, patients received 200mg hydroxychloroquine (HCQ) twice daily (400mg/day total) for 14 days prior to surgery.

Hydroxychloroquine, 200mg twice daily (400mg/day total) was given to subjects for up to 14 days prior to surgery.

Hydroxychloroquine, 200mg twice dailiy

Hydroxychloroquine, 400mg twice daily (800mg/day total) was given to subjects for up to 14 days prior to surgery.

Hydroxychloroquine, 400mg twice daily

Peng Wang, MD, PhD

Baseline levels of PAR-4 secreted by normal cells are generally inadequate to cause massive apoptosis in cancer cells and drugs that bolster the secretion of PAR-4 would constitute an important therapeutic advance.The apoptosis sensitizing features of hydroxychloroquine enhance the anti-tumor effects of a broad range of cancer therapeutics. The investigators hypothesize that hydroxychloroquine will induce at least 2-fold increase in systemic (plasma) PAR-4 levels compared to pre-treatment plasma levels in patients with resectable solid tumors.

HCQ on PAR-4 Levels in Patients With Resectable Solid Tumors

A Pilot Study to Determine the Biological Effects of Hydroxychloroquine on PAR-4 Levels in Patients With Resectable Solid Tumors

Number of patients with 2-fold change in Par-4 levels from baseline to day 14

Dose (mg twice daily) wherein 70% of patients exhibit a 2-fold increase in Par-4 levels with a dose-limiting toxicity of no more than 30%.

Peng Wang, MD PhD

Principal Investigator

Patients were queried about adverse events during study visits.

Hydroxychloroquine 14 days

Hydroxychloroquine: Hydroxychloroquine (200mg twice daily; 400mg total) was given to subjects for up to 14 days prior to surgery.

Initial: Hydroxychloroquine 400mg HCQ

Hydroxychloroquine 14 days

Hydroxychloroquine: Hydroxychloroquine (400mg twice daily; 800mg total) was given to subjects for up to 14 days prior to surgery.

Secondary: Hydroxychloroquine 800mg HCQ

Hydroxychloroquine 14 days

Hydroxychloroquine: Hydroxychloroquine (200mg twice daily, 400mg total) was given to subjects for up to 14 days prior to surgery.

Tertiary: Hydroxychloroquine 400mg HCQ

Hydroxychloroquine 14 days

Hydroxychloroquine: Hydroxychloroquine (200mg twice per day; 400mg total) was given to subjects for up to 14 days prior to surgery.

Hydroxychloroquine 14 days

Hydroxychloroquine: Hydroxychloroquine (400mg twice per day; 800mg total) was given to subjects for up to 14 days prior to surgery.

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Peng Wang

These initial 3 patients received 200mg hydroxychloroquine (HCQ) twice daily (400mg/day total) for 14 days prior to surgery.

Hydroxychloroquine, 200mg twice dailiy: Hydroxychloroquine, 200mg twice daily (400mg/day total) was given to subjects for up to 14 days prior to surgery.

Based on data analysis from the initial patients, these patients received 400mg hydroxychloroquine (HCQ) twice daily (800mg/day total) for 14 days prior to surgery.

Hydroxychloroquine, 400mg twice daily: Hydroxychloroquine, 400mg twice daily (800mg/day total) was given to subjects for up to 14 days prior to surgery.

Based on data from the primary and secondary groups, patients received 200mg hydroxychloroquine (HCQ) twice daily (400mg/day total) for 14 days prior to surgery.

Hydroxychloroquine, 200mg twice dailiy: Hydroxychloroquine, 200mg twice daily (400mg/day total) was given to subjects for up to 14 days prior to surgery.

Patients With Elevated Par-4 Levels

Optimal biological dose is calculated from aggregate data of all patients

All Patients

Optimal Biologic Dose of Hydroxychloroquine

These patients received 200mg hydroxychloroquine (HCQ) twice daily (400mg/day total) for 14 days prior to surgery.

These patients received 400mg hydroxychloroquine (HCQ) twice daily (800mg/day total) for 14 days prior to surgery.

Based on data from primary and secondary groups, these patients received 200mg hydroxychloroquine (HCQ) twice daily (400mg/day total) for 14 days prior to surgery.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
HCQ on PAR-4 Levels in Patients With Resectable Solid Tumors	NCT02232243	Solid Tumor	Hydroxychloroqu... Hydroxychloroqu...	18 Years -	University of Kentucky
HCQ on PAR-4 Levels in Patients With Resectable Solid Tumors	NCT02232243	Solid Tumor	Hydroxychloroqu... Hydroxychloroqu...	18 Years -	University of Kentucky

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