Solid TumorPhase 1NCT02232243
HCQ on PAR-4 Levels in Patients With Resectable Solid Tumors
A Phase 1 study testing Hydroxychloroquine, 200mg twice dailiy and Hydroxychloroquine, 400mg twice daily in people with Solid Tumor, run by Peng Wang, MD PhD at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Hydroxychloroquine, 200mg twice dailiy and Hydroxychloroquine, 400mg twice daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 1 Dec 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a histologically confirmed solid tumor that is planned for surgical resection.
- Age ≥18 years.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
- Patients must be able to ingest oral medications.
- Patients must have normal organ and marrow function as defined below:
- absolute neutrophil count ≥1,500/mcL
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- 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 ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- Patients must be able to undergo surgical resection of their tumor as determined by the treating surgeon.
- 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.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- 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.
- Uncontrolled intercurrent illness 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.
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- Pregnant women are excluded from this study.
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with hydroxychloroquine. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
- Patients that are on enzyme-inducing anti-epileptic medications
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky, Markey Cancer Center
Lexington, Kentucky, 40536
About this study
Official title: A Pilot Study to Determine the Biological Effects of Hydroxychloroquine on PAR-4 Levels in Patients With Resectable Solid Tumors
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.
- Conditions
- Solid Tumor
- Being tested
- Hydroxychloroquine, 200mg twice dailiy, Hydroxychloroquine, 400mg twice daily
- Keywords
- Cancer, Surgery, Hydroxychloroquine
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine, 200mg twice dailiyDrug
Hydroxychloroquine, 200mg twice daily (400mg/day total) was given to subjects for up to 14 days prior to surgery.
Hydroxychloroquine, 400mg twice dailyDrug
Hydroxychloroquine, 400mg twice daily (800mg/day total) was given to subjects for up to 14 days prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Initial: Hydroxychloroquine 400mg HCQ | Experimental | These initial 3 patients received 200mg hydroxychloroquine (HCQ) twice daily (400mg/day total) for 14 days prior to surgery. Receives: Drug: Hydroxychloroquine, 200mg twice dailiy |
| Secondary: Hydroxychloroquine 800mg HCQ | Experimental | 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. Receives: Drug: Hydroxychloroquine, 400mg twice daily |
| Tertiary: Hydroxychloroquine 400mg HCQ | Experimental | 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. Receives: Drug: Hydroxychloroquine, 200mg twice dailiy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients With Elevated Par-4 Levels
Number of patients with 2-fold change in Par-4 levels from baseline to day 14
Measured: Baseline and day 14
Optimal Biologic Dose of Hydroxychloroquine
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%.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startJul 2015
- Primary completion1 Jan 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peng Wang, MD PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peng Wang, MD PhD, University of Kentucky
- Investigators
- Peng Wang, MD, PhD, Principal investigator, Lucille P. Markey Cancer Center at University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232243
- Sponsor's protocol ID
- 14-MULTI-14-MCC
- Status last verified
- May 2019
- First submitted
- 2 Sep 2014
- Last updated
- 28 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang P, Burikhanov R, Jayswal R, Weiss HL, Arnold SM, Villano JL, Rangnekar VM. Neoadjuvant administration of hydroxychloroquine in a phase 1 clinical trial induced plasma Par-4 levels and apoptosis in diverse tumors. Genes Cancer. 2018 May;9(5-6):190-197. doi: 10.18632/genesandcancer.181.
PubMed 30603055
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Biological Effects of Hydroxychloroquine on PAR-4 Levels in Patients With Resectable Solid Tumors
- ClinicalTrials.gov ID
- NCT02232243
- Acronym / sponsor ID
- 14-MULTI-14-MCC
- Conditions
- Solid Tumor
- Keywords
- Cancer, Surgery, Hydroxychloroquine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Peng Wang, MD PhDUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 5 Sep 2014 (estimated)
- Results
- Posted 23 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Initial: Hydroxychloroquine 400mg HCQ | Experimental | Drug: Hydroxychloroquine, 200mg twice dailiyThese initial 3 patients received 200mg hydroxychloroquine (HCQ) twice daily (400mg/day total) for 14 days prior to surgery. |
| Secondary: Hydroxychloroquine 800mg HCQ | Experimental | Drug: Hydroxychloroquine, 400mg twice dailyBased on data analysis from the initial patients, these patients received 400mg hydroxychloroquine (HCQ) twice daily (800mg/day total) for 14 days prior to surgery. |
| Tertiary: Hydroxychloroquine 400mg HCQ | Experimental | Drug: Hydroxychloroquine, 200mg twice dailiyBased on data from the primary and secondary groups, patients received 200mg hydroxychloroquine (HCQ) twice daily (400mg/day total) for 14 days prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients must have a histologically confirmed solid tumor that is planned for surgical resection.
- Age ≥18 years.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
- Patients must be able to ingest oral medications.
- Patients must have normal organ and marrow function as defined below:
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxychloroquine, 200mg twice dailiyHydroxychloroquine, 200mg twice daily (400mg/day total) was given to subjects for up to 14 days prior to surgery. | Drug | Initial: Hydroxychloroquine 400mg HCQ, Tertiary: Hydroxychloroquine 400mg HCQ |
| Hydroxychloroquine, 400mg twice dailyHydroxychloroquine, 400mg twice daily (800mg/day total) was given to subjects for up to 14 days prior to surgery. | Drug | Secondary: Hydroxychloroquine 800mg HCQ |
Primary outcome
Patients With Elevated Par-4 Levels
Time frame: Baseline and day 14
Number of patients with 2-fold change in Par-4 levels from baseline to day 14
Optimal Biologic Dose of Hydroxychloroquine
Time frame: 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%.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30603055Wang P, Burikhanov R, Jayswal R, Weiss HL, Arnold SM, Villano JL, Rangnekar VM. Neoadjuvant administration of hydroxychloroquine in a phase 1 clinical trial induced plasma Par-4 levels and apoptosis in diverse tumors. Genes Cancer. 2018 May;9(5-6):190-197. doi: 10.18632/genesandcancer.181.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peng Wang, MD, PhD principal investigator
Lucille P. Markey Cancer Center at University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hydroxychloroquine, 200mg twice dailiy and Hydroxychloroquine, 400mg twice daily in people with Solid Tumor, run by Peng Wang, MD PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients With Elevated Par-4 Levels (time frame: Baseline and day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02232243, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2021.