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

• Status: Completed
• Trial end date: 2013-05-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI); Rutgers Cancer Institute of New Jersey
• Treatments: Hydroxychloroquine

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