The researchers are doing this study to find out whether the study drug hydroxychloroquine can prevent infection with the COVID-19 virus, compared with placebo, in people who are receiving radiation therapy for their cancer. The placebo used in this study is a tablet that looks the same as the study drug and is taken in the same way, but it does not contain any active ingredients.
Drug: Hydroxychloroquine
400mg daily
Other: Placebo
400mg daily
Radiation: Radiation therapy
Standard radiation therapy will be prescribed and administered as per the patient's radiation oncologist.
Inclusion Criteria:
- Age ≥ 18
- ECOG 0-3
- For patients who have not started radiation at the time of screening: patients are required to have a plan in place for a minimum of 10 radiation treatments with or without concurrent systemic therapy
- For patients who have already started radiation at the time of screening: patients must complete enrollment such that they are able to receive at least 10 radiation treatments with hydroxychloroquine.
- Disease Site
- Mandatory inclusion criteria:
- No COVID-19 symptoms within 14 days of enrollment: - (Temp >38C in addition to sore throat, cough, wheezing, chest tightness, shortness of breath, body aches, chills, diarrhea, and anosmia) - If symptoms are present within 14 days of enrollment, patients with a negative COVID-19 PCR or COVID-19 serology assay are eligible for inclusion.
- No close contact with confirmed COVID-19 person
- Close contact defined as: - Within 6 feet for prolonged period - Cohabitating
- Optional laboratory criteria (Recommended if available) - Negative pre-treatment SARS-CoV-2 rapid antigen test result (within 1 week of enrollment) - Negative pre-treatment SARS-CoV-2 PCR test result (within 1 week of enrollment) using MSKCC laboratory or outside laboratory assay - Negative pre-treatment Standard Q COVID-19 IgM/IgG rapid serology result (within 1 week of enrollment) - Blood serum for SARS-CoV-2 serology tests (being validated by MSKCC)
- Disease site meets following criteria: - Head and Neck / High-Risk Skin Cancer - Lung Cancer - Breast Cancer - Prostate Cancer - Central Nervous System Tumors - Gastrointestinal System Cancer - Gynecologic cancer - Other disease sites permitted at PI discretion
Exclusion Criteria:
- Previous positive test for SARS-CoV-2
- Previous positive serology test for SARS-CoV-2
- Recent Chest CT meeting CT exclusion criteria
- Live in a skilled nursing facility with COVID-19 symptoms (Temp >38 C in addition to sore throat, cough, wheezing, chest tightness, shortness of breath, body aches or chills, diarrhea, anosmia)
- Known hypersensitivity to hydroxychloroquine or 4-aminoquinoline derivatives
- Pre-existing retinopathy
- Known chronic kidney disease, stage 4 or 5, or receiving dialysis
- Breast Feeding
- Tamoxifen
- Absolute neutrophil Count 14 calendar days) CT Chest or PET/CT. If no prior comparison is available AND any intermediate or typical feature is present, the patient is not eligible.
- COVID-19 Atypical Features - Isolated lobar or segmental consolidation without GGO - Discrete small nodules (centrilobular, "tree-in-bud") - Lung cavitation - Smooth interlobular septal thickening with pleural effusion
- COVID-19 Indeterminate Features - Multifocal, diffuse, perihilar, or unilateral GGO with or without consolidation lacking a specific distribution and are non-rounded or non-peripheral - Few very small GGO with a non-rounded and non-peripheral distribution
- COVID-19 Typical Features - Peripheral, bilateral GGO with or without consolidation or visible intralobular lines ("crazy paving") - Multifocal GGO of rounded morphology with or without consolidation or visible intralobular lines ("crazy paving") - Reverse Halo sign or other findings of organizing pneumonia ** If pre-treatment QTC can be decreased to
Memoral Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Investigator: Nancy Lee, MD
Contact: 212-639-3341
Memoral Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, 07748
Investigator: Nancy Lee, MD
Contact: 212-639-3341
Memorial Sloan Kettering Bergen (All protocol Activities)
Montvale, New Jersey, 07645
Investigator: Nancy Lee, MD
Contact: 212-639-3341
Memorial Sloan Kettering Commack (All Protocol Activities)
Commack, New York, 11725
Investigator: Nancy Lee, MD
Contact: 212-639-3341
Memoral Sloan Kettering Westchester (All protocol activities)
Harrison, New York, 10604
Investigator: Nancy Lee, MD
Contact: 212-639-3341
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Investigator: Nancy Lee, MD
Contact: 212-639-3341
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553
Investigator: Nancy Lee, MD
Contact: 212-639-3341
Nancy Lee, MD
212-639-3341
leen2@mskcc.org
Yao Yu, MD
908-542-3427
Nancy Lee, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center