Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Biological Effects of Agent on PAR-4 Levels With Resected Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03015324
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Peng Wang, MD PhD, University of Kentucky

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: Hydroxychloroquine Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biological Effects of Maintenance Usage of Hydroxychloroquine on PAR-4 Levels in Patients With Resected Solid Tumors
Actual Study Start Date : August 8, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : September 2029

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hydroxychloroquine
Hydroxychloroquine
Drug: Hydroxychloroquine
Hydroxychloroquine




Primary Outcome Measures :
  1. PAR-4 increase [ Time Frame: 3 months ]
    Proportion of patients exhibiting a four-fold increase in PAR-4 levels


Secondary Outcome Measures :
  1. Complete Serological Response [ Time Frame: 12 months ]
    Rate of complete serological response in prostate cancer

  2. Progression free survival [ Time Frame: 12 months ]
    Progression free survival in other resected solid tumors



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015324


Contacts
Layout table for location contacts
Contact: Peng Wang, MD, PhD 859-323-3179 p.wang@uky.edu

Locations
Layout table for location information
United States, Kentucky
University of Kentucky Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Peng Wang, MD,PhD    859-393-3179    p.wang@uky.edu   
Sponsors and Collaborators
Peng Wang, MD PhD
Investigators
Layout table for investigator information
Principal Investigator: Peng Wang, MD, PhD University of Kentucky
Layout table for additonal information
Responsible Party: Peng Wang, MD PhD, Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT03015324    
Other Study ID Numbers: MCC-16-MULTI-17
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents