To determine the safety and tolerability of orally administered hydroxychloroquine with hormonal therapy. To assess the response rate of hydroxychloroquine in combination with hormonal therapy.
To determine the number of patients with adverse effects To assess the clinical response to the combination
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
administration of hydroxychloroquine in combination with the current hormonal therapy
Western Regional Medical Center, Inc.
Goodyear, Arizona, United States
Number of Participants with Adverse Events as a Measure of the safety profile of orally administered hydroxychloroquine with hormonal therapy
Assess the dose-limiting side effects such as neutropenia, anemia, or thormbocytopenia, or non-hematologic side effects nausea, vomiting, diarrhea, or vision problems at the study dose
Time frame: 18 months
The recommended phase 2 clinical dose (RP2D) of orally administered hydroxychloroquine with hormonal therapy
orally administered hydroxychloroquine with hormonal therapy
Time frame: 18 months
The pharmacodynamic (PD) profile of hydroxychloroquine with hormonal therapy
microtubule-associated protein 1 light chain 3 b (LC3b) level in the biopsy, WBCs in pre- and post-treatment samples
Time frame: 18 months
The anti-tumor activity of hydroxychloroquine with hormonal therapy with clinical benefit rate (CBR). Clinical benefits are defined as complete remission (CR), partial remission (PR) and stable disease (SD)
The anti-tumor activity of hydroxychloroquine with hormonal therapy with clinical benefit rate (CBR). Clinical benefits are defined as complete remission (CR), partial remission (PR) and stable disease (SD)
Time frame: 18 months
The disease-free survival (DFS) when adding hydroxychloroquine to hormonal therapy
The disease-free survival (DFS) when adding hydroxychloroquine to hormonal therapy
Time frame: 18 months
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