Study of Hydroxychloroquine Before Surgery in Patients With Primary Renal Cell Carcinoma

Exclusion Criteria

• •Subjects who have received chemotherapy for any diagnosis within 12 months prior to study entry.
• •Prior use of radiotherapy or investigational agents for RCC.
• •Concurrent malignancies with evidence of active or measurable disease except non-melanoma skin cancer
• •Inability to adhere to study and/or follow-up procedures
• •History of allergic reactions or hypersensitivity to the study drug (hydroxychloroquine) or current therapy with the study drug for other reasons.
• •Other concurrent experimental therapy.
• •The effects of HC on the developing human fetus are unknown. For this reason 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. All females of childbearing potential must have a blood test or urine study within two weeks prior to registration to rule out pregnancy. Should a woman become pregnant while participating in this study, she should inform her treating physician immediately. If a man impregnates a woman while participating in this study, he should inform his treating physician immediately as well.
• •HIV-positive patients are not excluded from the study. However, for patients receiving combination anti-retroviral therapy, the potential impact of pharmacokinetic interactions with HC is unknown. Therefore, HIV-positive patients actively receiving anti-retroviral therapy are excluded from the study.
• •Patients with psoriasis are ineligible unless the disease is well controlled and they are under the care of a specialist who agrees to monitor the patient for exacerbations.
• •Patients requiring the use of enzyme-inducing anti-epileptic medication that includes: phenytoin, carbamazepine, phenobarbital, primidone or oxcarbazepine are excluded. Hydroxychloroquine is known to affect the CYP2D6 metabolic pathway. A list of drugs with potential interaction is included in Appendix H.
• •Patients with previously documented macular degeneration or diabetic retinopathy are excluded.
• •Patients with known glucose-6-phosphate dehydrogenase (GP6D) deficiency
• •EKG with QTc \>500 msec at baseline (average of 3 determinations at 10 minutes interval). Subjects with ventricular pacemaker for whom QT interval is not measurable will be eligible on a case-by-case basis.