Hydroxychloroquine in Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery (NCT00962845) | Clinical Trial Compass
CompletedEarly Phase 1
Hydroxychloroquine in Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery
United States20 participantsStarted 2010-09
Plain-language summary
RATIONALE: Studying samples of blood, tumor tissue, and skin in the laboratory from patients with melanoma receiving hydroxychloroquine may help doctors understand the effect of hydroxychloroquine on biomarkers.
PURPOSE: This early phase I trial is studying hydroxychloroquine in patients with stage III or stage IV melanoma that can be removed by surgery.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed melanoma
* Stage III or IV disease
* Has ≥ 2 resectable tumors OR tumor large enough to undergo pre-treatment core needle biopsy
* Must be a candidate for curative or palliative surgical resection of disease
* Brain metastases allowed provided they were previously treated and have been stable for \> 2 weeks
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Absolute granulocyte count \> 1,500/mm³
* Platelet count \> 100,000/mm³
* SGOT and SGPT \< 2.5 times upper limit of normal (ULN)
* Negative pregnancy test
* Fertile patients must use effective contraception
* No history of any social or medical condition that, in the opinion of the investigator, may interfere with the patient's ability to comply with the study or pose additional or unacceptable risk to the patient
* No concurrent serious systemic disorder that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
* No active clinically significant infection requiring antibiotics
* No hypertension that cannot be controlled by medication (i.e., diastolic blood pressure \> 100 mm Hg despite optimal medical therapy)
* No pre-existing thyroid abnormality with thyroid-stimulating hormone that cannot be maintained in the normal range with medication
* No known HIV positivity
* No psoriasis or porphyria
* No known hypersensitivity to 4-aminoquinoline compounds
* No r…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Modulation of markers of autophagy by hydroxychloroquine (HCQ), as measured by p62, Beclin1, LC3, and GRp170 expression
Timeframe: 1 year
Trial details
NCT IDNCT00962845
SponsorRutgers, The State University of New Jersey