HCQ on PAR-4 Levels in Patients With Resectable Solid Tumors

Inclusion Criteria:

- Patients must have a histologically confirmed solid tumor that is planned for surgical
resection.

- Age ≥18 years.

- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).

- Patients must be able to ingest oral medications.

- Patients must have normal organ and marrow function as defined below:

- absolute neutrophil count ≥1,500/mcL

- platelets ≥100,000/mcL

- total bilirubin Less than 1.5 x ULN

- AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal

- Creatinine within normal institutional limits OR Creatinine clearance ≥60
mL/min/1.73 m2 for patients with creatinine levels above institutional normal.

- Patients must be able to undergo surgical resection of their tumor as determined by
the treating surgeon.

- 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.

- Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

- Patients with metastatic cancer and/or cancer that is not amenable to surgery.

- Patients with significant malabsorption as determined by the treating physician.

- Patients who are receiving any other investigational agents.

- Patients with known brain metastases are excluded from this clinical trial because of
their poor prognosis and because they often develop progressive neurologic dysfunction
that would confound the evaluation of neurologic and other adverse events. Patients
with primary brain tumors amenable to surgery are allowed on this protocol.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to hydroxychloroquine.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Pregnant women are excluded from this study.

- HIV-positive patients on combination antiretroviral therapy are ineligible because of
the potential for pharmacokinetic interactions with hydroxychloroquine. In addition,
these patients are at increased risk of lethal infections when treated with
marrow-suppressive therapy.

- Patients that are on enzyme-inducing anti-epileptic medications