SWOG clinical trial number

Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Cytotoxic Therapy for Solid Tumors

Abbreviated Title
Rando Prophylactic Antiviral HBV
Status Notes
Active 2/21/19
Temporary Closure, effective 5/20/2020

Research committees

Symptom Control and Quality of Life
Breast Cancer
Gastrointestinal Cancer
Genitourinary Cancer
Lung Cancer


Tenofovir alafenamide

Eligibility Criteria Expand/Collapse

- Stage I-III solid tumor malignancy (carcinoma in situ or Stage IV disease only are excluded).
- No malignancy other than the current malignancy within the past five years (except of basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ breast cancer).
- No lymphoma, leukemia, or myeloma.
- No primary liver cancer, known cirrhosis, or evidence of any malignancy that involves the liver.
- Must be planning to receive systemic anti-cancer therapy (single agent or combination therapies) for this solid tumor.
- No previous treatment with the same anti-cancer therapy regimen that is now anticipated (but anti-cancer therapy does not have to be first-line). Prior and/or concurrent radiotherapy is allowed.
- Must be registered </= 28 days prior to the planned start date of anti-cancer therapy (OR if already started, </= 28 days after the initiation of first cycle of anti-cancer therapy OR prior to the second cycle of the anti-cancer therapy, whichever occurs earlier).
- INR </= 28 days prior to registration. Results must be in ILN.
- Discontinued all previous anti-cancer therapies (excluding planned anti-cancer therapy to occur in conjunction with this study) >/= 1 day prior to reg.
- No previous anti-CD20.
- No antiviral meds active against HBV (adefovir, entecavir, lamivudine, telbivudine, tenofovir disoproxil fumarate, tenofovir alafenamide, or any other FDA approved agents for Hepatitis B). No antiviral meds active against HBV within 90 days prior to reg.
- No previous hematopoietic stem cell transplant.
- Must discontinue and not be planning to take: acyclovir, aminoglycosides, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, valacyclovir, high-dose NSAIDs (“high-dose” based on package insert), and St. John’s Wort.
- Patients must have HBV test results (HBsAg AND anti-HBc [total Ig or IgG, but not IgM only] AND anti-HBs) </= 30 days prior to reg.
- Must test positive for HBsAg or anti-HBc (total Ig, IgG, but not IgM) and must have baseline HBV DNA completed </= 90 days prior to reg.
- Must have CBC within ILN </= 28 days prior to reg.
- Must have ALT, total bilirubin and creatinine results within ILN </= 28 days prior to reg.
- No known current active HCV (defined by a detectable HCV RNA level).
- No HIV infection. HIV test must be </=365 days prior to reg.
- Must have Zubrod performance status of 0-2.
- Must be able to swallow tablets orally.
- Must be >/= 18 years old.
- Must not be pregnant or nursing and must have agreed to use an effective contraceptive method if of reproductive potential.
- Must have specimens collected for submission.
- Must be offered the opportunity to participate in optional translational medicine studies.
- May have concurrent participation in other clinical trials that entail cytotoxic, immunotherapy, targeted therapy; surgical treatment; radiotherapy treatment; or any combination thereof.
- Must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
- Must have current IRB approval.

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