Skip to main content

Tenofovir Alafenamide in Preventing Liver Complications in Patients with Current or Past Hepatitis B Virus Who are Receiving Anti-Cancer Therapy for Solid Tumors

Trial Status: Temporarily Closed to Accrual

This phase III trial studies how well tenofovir alafenamide works 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.

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, in situ cervical cancer, or in situ breast cancer
  • 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 =< 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
  • International normalized ratio (INR) must be completed =< 28 days prior to registration; results must be in the institutional limits of normal
  • 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 complete results for the following HBV tests done =< 30 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 =< 90 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
  • INR must be completed within 28 days prior to registration; results must be in the normal range
  • Alanine aminotransferase (ALT) must be obtained =< 28 days prior to registration; ALT must be within normal limits (> institutional lower limit of normal [ILLN] and < institutional upper limit of normal [IULN]) for the institution
  • Total bilirubin must be obtained =< 28 days prior to registration; total bilirubin must be within normal limits (> ILLN and < IULN) for the institution
  • Creatinine must be obtained =< 28 days prior to registration; creatinine must be within normal limits (> ILLN and < IULN) for the institution
  • Patients must not have known current active hepatitis C infection (HCV); active HCV is defined by a detectable HCV ribonucleic acid (RNA) level
  • Patients must not have a history of human immunodeficiency (HIV) infection; all patients must have HIV testing completed =< 365 days prior to registration
  • Patients must have Zubrod performance status of 0-2
  • Patients must be able to swallow tablets orally
  • 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

Arkansas

Ft. Smith
Mercy Hospital Fort Smith
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-378-9373

California

Anaheim
Kaiser Permanente-Anaheim
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-398-3996
Antioch
Kaiser Permanente-Deer Valley Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Baldwin Park
Kaiser Permanente-Baldwin Park
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-398-3996
Bellflower
Kaiser Permanente-Bellflower
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-398-3996
Dublin
Epic Care-Dublin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 925-875-1677
Kaiser Permanente Dublin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Emeryville
Bay Area Breast Surgeons Inc
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 510-835-9900
Epic Care Partners in Cancer Care
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 510-629-6682
Fontana
Kaiser Permanente-Fontana
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-398-3996
Fremont
Kaiser Permanente-Fremont
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Fresno
Fresno Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Kaiser Permanente-Fresno
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Harbor City
Kaiser Permanente - Harbor City
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-398-3996
Irvine
Kaiser Permanente-Irvine
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-398-3996
Long Beach
Tibor Rubin VA Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 562-826-8000
Los Angeles
Kaiser Permanente Los Angeles Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-398-3996
Kaiser Permanente-Cadillac
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-398-3996
Los Angeles County-USC Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 323-865-0451
USC / Norris Comprehensive Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 323-865-0451
Martinez
Contra Costa Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 925-957-5400
Modesto
Kaiser Permanente-Modesto
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Newport Beach
USC Norris Oncology / Hematology-Newport Beach
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 323-865-0451
Oakland
Alta Bates Summit Medical Center - Summit Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 510-204-1414
Bay Area Tumor Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 510-465-2242
Kaiser Permanente Oakland-Broadway
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Kaiser Permanente-Oakland
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Panorama City
Kaiser Permanente - Panorama City
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-398-3996
Pasadena
Keck Medical Center of USC Pasadena
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 323-865-0451
Rancho Cordova
Kaiser Permanente-Rancho Cordova Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Redwood City
Kaiser Permanente-Redwood City
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Richmond
Kaiser Permanente-Richmond
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Riverside
Kaiser Permanente-Riverside
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-398-3996
Rohnert Park
Rohnert Park Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Roseville
Kaiser Permanente-Roseville
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
The Permanente Medical Group-Roseville Radiation Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Sacramento
Kaiser Permanente - Sacramento
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Kaiser Permanente Downtown Commons
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: kpoct@kp.org
Kaiser Permanente-South Sacramento
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
South Sacramento Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Diego
Kaiser Permanente-San Diego Zion
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-398-3996
San Francisco
Kaiser Permanente-San Francisco
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Jose
Kaiser Permanente-Santa Teresa-San Jose
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Leandro
Kaiser Permanente San Leandro
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Marcos
Kaiser Permanente-San Marcos
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-398-3996
San Rafael
Kaiser Permanente-San Rafael
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Kaiser San Rafael-Gallinas
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Santa Clara
Kaiser Permanente Medical Center - Santa Clara
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Santa Rosa
Kaiser Permanente-Santa Rosa
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
South San Francisco
Kaiser Permanente Cancer Treatment Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Kaiser Permanente-South San Francisco
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Stockton
Kaiser Permanente-Stockton
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Vacaville
Kaiser Permanente Medical Center-Vacaville
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Vallejo
Kaiser Permanente-Vallejo
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Walnut Creek
Epic Care Cyberknife Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 510-465-8016
Kaiser Permanente-Walnut Creek
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Woodland Hills
Kaiser Permanente-Woodland Hills
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-398-3996

Florida

Deerfield Beach
Broward Health North
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 954-941-8300
Fort Lauderdale
Broward Health Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 954-355-5346

Georgia

Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 912-819-5704

Hawaii

Aiea
Hawaii Cancer Care - Savio
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-539-2273
Pali Momi Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-486-6000
Queen's Cancer Center - Pearlridge
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-487-7447
The Cancer Center of Hawaii-Pali Momi
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-678-9000
Honolulu
Hawaii Cancer Care Inc-Liliha
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-536-4888
Hawaii Cancer Care Inc-POB II
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-524-6115
Island Urology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-536-2306
Kaiser Permanente Moanalua Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-432-5195
Kapiolani Medical Center for Women and Children
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-983-6090
Kuakini Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-547-9816
Queen's Cancer Cenrer - POB I
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-532-0315
Queen's Cancer Center - Kuakini
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-531-8521
Queen's Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-545-8548
Straub Clinic and Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-522-4333
The Cancer Center of Hawaii-Liliha
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-547-6881
University of Hawaii Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-586-2979
Lihue
Wilcox Memorial Hospital and Kauai Medical Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 808-535-7960

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Coeur D'Alene
Kootenai Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Emmett
Walter Knox Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Meridian
Idaho Urologic Institute-Meridian
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Nampa
Saint Alphonsus Medical Center-Nampa
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Post Falls
Kootenai Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Sandpoint
Kootenai Cancer Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060

Illinois

Aurora
Rush - Copley Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 630-978-6212
Chicago
Northwestern University
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 312-695-1301
Danville
Carle on Vermilion
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Effingham
Carle Physician Group-Effingham
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Mount Vernon
Good Samaritan Regional Health Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 618-242-4600
Urbana
Carle Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
The Carle Foundation Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Yorkville
Rush-Copley Healthcare Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 630-978-6212

Kansas

Chanute
Cancer Center of Kansas - Chanute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Dodge City
Cancer Center of Kansas - Dodge City
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
El Dorado
Cancer Center of Kansas - El Dorado
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Garden City
Central Care Cancer Center - Garden City
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Great Bend
Central Care Cancer Center - Great Bend
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Independence
Cancer Center of Kansas-Independence
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Kingman
Cancer Center of Kansas-Kingman
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Lawrence
Lawrence Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 785-505-2800
Lenexa
Kansas Institute of Medicine Cancer and Blood Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Minimally Invasive Surgery Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Liberal
Cancer Center of Kansas-Liberal
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Manhattan
Cancer Center of Kansas-Manhattan
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5784
McPherson
Cancer Center of Kansas - McPherson
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Newton
Cancer Center of Kansas - Newton
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Overland Park
Menorah Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Parsons
Cancer Center of Kansas - Parsons
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Pratt
Cancer Center of Kansas - Pratt
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Salina
Cancer Center of Kansas - Salina
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Wellington
Cancer Center of Kansas - Wellington
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Wichita
Associates In Womens Health
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Cancer Center of Kansas - Wichita
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Cancer Center of Kansas-Wichita Medical Arts Tower
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Winfield
Cancer Center of Kansas - Winfield
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374

Louisiana

Monroe
Ochsner LSU Health Monroe Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 318-813-1404
Shreveport
LSU Health Sciences Center at Shreveport
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 318-813-1404

Minnesota

Burnsville
Fairview Ridges Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Cambridge
Cambridge Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Coon Rapids
Mercy Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Edina
Fairview Southdale Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Fridley
Unity Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Maple Grove
Fairview Clinics and Surgery Center Maple Grove
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Saint John's Hospital - Healtheast
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Minneapolis
Abbott-Northwestern Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Health Partners Inc
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Hennepin County Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Monticello
Monticello Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
New Ulm
New Ulm Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Princeton
Fairview Northland Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Robbinsdale
North Memorial Medical Health Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Saint Paul
Regions Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
United Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Shakopee
Saint Francis Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Stillwater
Lakeview Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Waconia
Ridgeview Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Willmar
Rice Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Woodbury
Minnesota Oncology Hematology PA-Woodbury
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Wyoming
Fairview Lakes Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517

Mississippi

Jackson
University of Mississippi Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 601-815-6700

Missouri

Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-251-7058
Bolivar
Central Care Cancer Center - Bolivar
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Branson
Cox Cancer Center Branson
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 417-269-4520
Independence
Centerpoint Medical Center LLC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Joplin
Freeman Health System
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 417-347-4030
Mercy Hospital Joplin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 417-556-3074
Kansas City
Research Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Rolla
Delbert Day Cancer Institute at PCRMC
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 573-458-8776
Mercy Clinic-Rolla-Cancer and Hematology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 573-458-6379
Saint Joseph
Heartland Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 816-271-7937
Saint Louis
Mercy Hospital Saint Louis
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-251-7066
Mercy Hospital South
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Saint Louis Cancer and Breast Institute-South City
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-353-1870
Springfield
CoxHealth South Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 417-269-4520
Mercy Hospital Springfield
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 417-269-4520
Washington
Mercy Hospital Washington
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 636-390-1600

Montana

Anaconda
Community Hospital of Anaconda
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Billings
Billings Clinic Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-996-2663
Bozeman
Bozeman Deaconess Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Great Falls Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Helena
Saint Peter's Community Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Kalispell
Kalispell Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Missoula
Community Medical Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 212-305-6361

Oklahoma

Oklahoma City
Mercy Hospital Oklahoma City
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 405-752-3402

Oregon

Baker City
Saint Alphonsus Medical Center-Baker City
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Ontario
Saint Alphonsus Medical Center-Ontario
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Portland
Kaiser Permanente Northwest
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-335-2400

South Carolina

Easley
Prisma Health Cancer Institute - Easley
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Greenville
Prisma Health Cancer Institute - Butternut
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Prisma Health Cancer Institute - Eastside
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Prisma Health Cancer Institute - Faris
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Prisma Health Greenville Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Greer
Prisma Health Cancer Institute - Greer
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Seneca
Prisma Health Cancer Institute - Seneca
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066
Spartanburg
Prisma Health Cancer Institute - Spartanburg
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-522-2066

Texas

Houston
M D Anderson Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-632-6789

Washington

Seattle
Kaiser Permanente Washington
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 206-215-3086

Wisconsin

New Richmond
Cancer Center of Western Wisconsin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517

Wyoming

Cody
Billings Clinic-Cody
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-996-2663
Sheridan
Welch Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060

PRIMARY OBJECTIVES:

I. To compare the effect of prophylactic tenofovir alafenamide (TAF) therapy versus upon indication TAF therapy on time-to-adverse liver outcomes of liver failure or liver-related death in patients with chronic HBV infection (hepatitis B surface antigen positive [HBsAg+] and antibody to hepatitis B core antigen positive [anti-HBc+]) receiving anti-cancer therapy for solid tumors.

II. To compare the effect of upon indication TAF therapy versus usual care on time-to-adverse liver outcomes of liver failure or liver-related death in patients with past HBV infection (hepatitis B surface antigen negative [HBsAg-] and anti-HBc+) receiving anti-cancer therapy for solid tumors.

SECONDARY OBJECTIVES:

I. Using time-to-event analysis, to compare the effect of TAF therapy versus upon indication TAF therapy on HBV reactivation, on the combined endpoint of adverse liver outcomes (liver failure or liver-related death) and HBV reactivation, and on HBV flare by arm in patients with chronic HBV infection receiving anti-cancer therapy for solid tumors.

II. Using time-to-event analysis, to compare the effect of upon indication TAF therapy versus usual care on HBV reactivation, on the combined endpoint of adverse liver outcomes (liver failure or liver-related death) and HBV reactivation, and on HBV flare by arm in patients with past HBV infection receiving anti-cancer therapy for solid tumors.

TRANSLATIONAL OBJECTIVES:

I. To compare baseline and changes in overall immune status and HBV-specific immune response in patients with solid tumors and chronic or past HBV infection receiving anti-cancer therapy, and to compare the differences in these immune responses by HBV reactivation status.

II. To identify demographic and clinical predictors and correlative immunologic biomarkers of HBV reactivation after receipt of anti-cancer therapy in patients with solid tumors and chronic or past HBV infection.

OUTLINE: Patients are randomized to 1 of 3 groups.

GROUP A (Cohorts 1a & 2a): Patients receive TAF orally (PO) once daily (QD) immediately or within 28 days after initial dose of chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.

GROUP B (Cohorts 1b & 2b): Patients receive TAF PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.

GROUP C (Cohort 3): Patients receive TAF PO QD at the discretion of the physician during usual care. Treatment continues for up to 6 months after discontinuation of usual care or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 4 weeks for up to 24 months.

Trial Phase Phase III

Trial Type Prevention

Lead Organization
SWOG

Principal Investigator
Jessica P. Hwang

  • Primary ID S1614
  • Secondary IDs NCI-2018-00592, SWOG-S1614
  • Clinicaltrials.gov ID NCT03887702