Melanoma Clinical Trial

Hydroxychloroquine in Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery

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.

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Full Description

OBJECTIVES:

Primary

To characterize the effects of hydroxychloroquine (HCQ) on the modulation of markers of autophagy, as measured by p62, Beclin1, LC3, and GRp170 expression, in pre- and post-treatment tumor biopsy samples, skin samples, and peripheral blood mononuclear cell samples from patients with stage III or IV melanoma undergoing palliative or curative surgery.

Secondary

To determine whether the steady-state plasma concentration of HCQ correlates with observed trends in induced markers of autophagy.
To determine the potential mechanisms of antitumor effect of HCQ, as measured by a reduction in tumor cell proliferation (Ki-67 and mitotic rate) or an increase in apoptosis (activated caspase-3 and TUNEL assays) in melanoma specimens.

OUTLINE: Patients receive oral hydroxychloroquine twice daily for 14 days in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.

Blood, tumor tissue, and skin samples are collected for pharmacokinetic and correlative laboratory studies. Expression of p62, Beclin1, LC3, and GRp170 (autophagy markers) is analyzed.

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Eligibility Criteria

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 retinal or visual field changes from prior 4-aminoquinoline compound use
No known G-6P deficiency
No known gastrointestinal pathology that would interfere with drug bioavailability
No known prior hypersensitivity to hydroxychloroquine or any of its components
No clinically significant bleeding or clotting disorder that would preclude curative or palliative surgery

PRIOR CONCURRENT THERAPY:

Recovered from prior therapy
More than 2 weeks since prior cytotoxic or biologic agents (6 weeks for mitomycin or nitrosoureas)
At least 2 weeks since prior surgery, radiotherapy, hormonal therapy, or other drug therapy for melanoma
No concurrent treatment for rheumatoid arthritis or systemic lupus erythematosus
No concurrent disease-modifying anti-rheumatic drugs
No concurrent hydroxychloroquine for treatment or prophylaxis of malaria
No concurrent aurothioglucose or antimalarial agents
No other concurrent chemotherapy, immunotherapy, hormonal therapy, radiotherapy, or surgery for cancer
No other concurrent investigational agents

Study is for people with:

Melanoma

Phase:

Early Phase 1

Estimated Enrollment:

20

Study ID:

NCT00962845

Recruitment Status:

Completed

Sponsor:

Rutgers, The State University of New Jersey

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There is 1 Location for this study

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Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Early Phase 1

Estimated Enrollment:

20

Study ID:

NCT00962845

Recruitment Status:

Completed

Sponsor:


Rutgers, The State University of New Jersey

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