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 range18 Years – 120 Years
SexALL
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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…
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