Overview

Prophylactic Antiviral Therapy in Patients With Current or Past Hepatitis B Virus Infection Receiving Anti-Cancer Therapy for Solid Tumors

Status:
Recruiting
Trial end date:
2027-02-01
Target enrollment:
0
Participant gender:
All
Summary
This phase III trial studies the effect of tenofovir alafenamide in preventing liver complications in patients with current or past hepatitis B virus (HBV) who are receiving anti-cancer therapy for solid tumors. People with chronic or past HBV who are undergoing therapy for cancer are at an increased risk for changes in the liver which could be minor or severe. Tenofovir alafenamide is a drug that acts against infections caused by HBV and may help reduce the chance that HBV gets worse or comes back in patients receiving anti-cancer therapy for solid tumors.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Southwest Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
Entecavir
Tenofovir
Criteria
Inclusion Criteria:

- Patients must be diagnosed with stage I-III solid tumor malignancy; patients with only
carcinoma in situ or with stage IV disease are excluded

- Patients must not have been diagnosed with a malignancy other than the current
malignancy within the past five years, with the exception of basal cell or squamous
cell skin cancer, or non-invasive (in situ) malignancies of the cervix, breast, or
skin

- Patients must not have lymphoma, leukemia, or myeloma

- Patients must not have primary liver cancer, known cirrhosis, or evidence of any
malignancy that involves the liver

- Patients must be planning to receive systemic anti-cancer therapy (either single agent
or some combination of systemic cytotoxic therapy, systemic immunotherapy or systemic
targeted therapy) for this solid tumor

- Patients must not have been previously treated with the same anti-cancer therapy
regimen that is now anticipated; the anti-cancer therapy does not have to be
first-line therapy; prior and/or concurrent radiotherapy is allowed

- Patients must be registered =< 28 days prior to the planned start date of anti-cancer
therapy; if the patient has started systemic anti-cancer therapy, patient must be
registered =< 42 days after the initiation of first cycle of anti-cancer therapy

- Patients who have received prior anti-cancer therapy must have discontinued all
previous therapies (excluding planned anti-cancer therapy to occur in conjunction with
this study) >= 1 day prior to registration to this study

- Patients must not have had any cancer therapy regimen that includes anti-CD20

- Patients must not be receiving antiviral medications active against HBV, including:
adefovir, entecavir, lamivudine, telbivudine, tenofovir disoproxil fumarate, tenofovir
alafenamide (TAF), or any other Food and Drug Administration (FDA) approved agents for
the treatment of hepatitis B; patients who have previously received antiviral
medication must not have required any antiviral medication active against HBV >= 90
days prior to registration to this study

- Patients must not have had hematopoietic stem cell transplantation therapy

- Patients receiving any of the following medications must discontinue them (under the
supervision of their treating physician) prior to registration, and must not be
planning to take them during protocol therapy: acyclovir, aminoglycosides,
oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine,
valacyclovir, high-dose nonsteroidal anti-inflammatory drugs (NSAIDs), ("high-dose"
based on package insert), and St. John's wort

- Patients must have results for the following HBV tests done within 28 days prior to
registration: HBsAg AND anti-HBc (total immunoglobulin [Ig] or IgG, but not IgM only)
AND hepatitis B surface antibody (anti-HBs); for the anti-HBs test, quantitative or
qualitative (including "indeterminate") results are allowable

- Patients must have tested positive for HBsAg or anti-HBc (total Ig, IgG, but not IgM)
and must have baseline HBV deoxyribonucleic acid (DNA) completed =< 42 days prior to
registration

- Complete blood count (CBC) must be completed =< 28 days prior to registration; results
do not need to be in the institutional limits of normal

- International normalized ratio (INR) must be completed =< 28 days prior to
registration; results must < 1.2 x institutional limits of normal

- Alanine aminotransferase (ALT) must be obtained =< 28 days prior to registration; ALT
must be =< 1.5 x institutional ULN

- Total bilirubin must be obtained =< 28 days prior to registration; total bilirubin
must be =< 1.5 x institutional ULN

- Creatinine results must be obtained =< 28 days prior to registration; creatinine must
be =< 1.5 x institutional ULN

- Patients must not have known current active hepatitis C infection (HCV); active HCV is
defined by a detectable HCV ribonucleic acid (RNA) level; Note: HCV testing is not
required for eligibility

- Patients must not have a history of human immunodeficiency (HIV) infection; patients
with unknown HIV status must have HIV testing completed =< 365 days prior to
registration

- Patients must have Zubrod performance status of 0-2

- Patients must not be pregnant or nursing, as the safety of the study drug in pregnant
and nursing women has not been established; women/men of reproductive potential must
have agreed to use an effective contraceptive method; a woman is considered to be of
"reproductive potential" if she has had menses at any time in the preceding 12
consecutive months; in addition to routine contraceptive methods, "effective
contraception" also includes heterosexual celibacy and surgery intended to prevent
pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy,
bilateral oophorectomy or bilateral tubal ligation; however, if at any point a
previously celibate patient chooses to become heterosexually active during the time
period for use of contraceptive measures outlined in the protocol, he/she is
responsible for beginning contraceptive measures

- Patients must have specimens collected for submission as outlined

- Patients must be offered the opportunity to participate in optional translational
medicine studies as outlined

- Patients with impaired decision-making capacity are eligible as long as their
neurological or psychological condition does not preclude their safe participation in
the study (e.g., tracking pill consumption and reporting adverse events to the
investigator)

- Patients may have concurrent participation in other clinical trials that entail
cytotoxic, immunotherapy, targeted therapy; surgical treatment; radiotherapy
treatment; or any combination thereof

- Patients 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

- As a part of the Oncology Patient Enrollment Network (OPEN) registration process the
treating institution's identity is provided in order to ensure that the current
(within 365 days) date of institutional review board approval for this study has been
entered in the system