- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03015324
Biological Effects of Agent on PAR-4 Levels With Resected Solid Tumors
January 24, 2022 updated by: Peng Wang, MD PhD
Biological Effects of Maintenance Usage of Hydroxychloroquine on PAR-4 Levels in Patients With Resected Solid Tumors
Hydroxychloroquine will be administered on an outpatient basis within 12 weeks after primary surgery followed by adjuvant chemotherapy /or radiation therapy (if needed).
Hydroxychloroquine will be administered orally at a dose of 400 mg daily for 90 days.
Subjects will receive HCQ every day.
Study Overview
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536
- University of Kentucky Markey Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically confirmed solid tumor that is surgically resected
- Have completed all planned adjuvant therapy or are not planned for adjuvant therapy
- Age ≥18 years
- ECOG performance status ≤1 (Karnofsky ≥80%)
- Patients must be able to ingest oral medications (crushing and administering via PEG tube is acceptable)
- Patients must have normal organ and marrow function as defined below:
- absolute neutrophil count ≥1,500/mcL
- platelets ≥100,000/mcL
- total bilirubin Less than 1.5 x ULN
- AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
- creatinine within normal institutional limits OR creatinine clearance ≥50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- The effects of hydroxychloroquine on the developing human fetus are unknown. For this reason, and because anti-malarial agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (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 she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and four months after completion of hydroxychloroquine administration.
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and four months after completion of hydroxychloroquine administration.
- Ability to understand and the willingness to sign a written informed consent document.
- Approval for hydroxychloroquine treatment by an eye doctor, based on a screening eye exam.
Exclusion Criteria:
- Patients with metastatic cancer and/or cancer that is not amenable to surgery.
- Patients with significant malabsorption as determined by the treating physician.
- Patients who are receiving any other investigational agents.
- Patients with known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with primary brain tumors amenable to surgery are allowed on this protocol.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to hydroxychloroquine or received HCQ in the past six months.
- Caution should be taken with the use of hydroxychloroquine and any drugs known to interact with it (Appendix B). Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated list such as http://medicine.iupui.edu/clinpharm/ddis/table.aspx
- Patients with uncontrolled intercurrent illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study.
- HIV-positive patients on combination antiretroviral therapy are ineligible
- Patients that are on enzyme-inducing anti-epileptic medications.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hydroxychloroquine
|
Hydroxychloroquine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PAR-4 increase
Time Frame: 3 months
|
Proportion of patients exhibiting a four-fold increase in PAR-4 levels
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete Serological Response
Time Frame: 12 months
|
Rate of complete serological response in prostate cancer
|
12 months
|
Progression free survival
Time Frame: 12 months
|
Progression free survival in other resected solid tumors
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peng Wang, MD, PhD, University of Kentucky
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 8, 2017
Primary Completion (Actual)
February 3, 2020
Study Completion (Actual)
February 2, 2021
Study Registration Dates
First Submitted
December 13, 2016
First Submitted That Met QC Criteria
January 6, 2017
First Posted (Estimate)
January 10, 2017
Study Record Updates
Last Update Posted (Actual)
January 25, 2022
Last Update Submitted That Met QC Criteria
January 24, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC-16-MULTI-17
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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