Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Anti-Infective Agents

All Drugs and Chemicals

Lamivudine

Lamivudine, zidovudine drug combination

Reverse Transcriptase Inhibitors

Enzyme Inhibitors

Antiviral Agents

Anti-HIV Agents

Anti-Retroviral Agents

* Lamivudine administered orally every 4 weeks
* Treatment cycles will last 28 consecutive days
* The dosage will be determine by the PI

This drug may help prevent the growth and spread of the cancer cells to other parts of the body.

Aparna R. Parikh, MD

This research study is studying a drug as a possible treatment for p53 mutant metastatic colorectal cancer.

The drug involved in this study is:

-Lamivudine

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.

The FDA (the U.S. Food and Drug Administration) has not approved lamivudine for this specific disease but it has been approved for other uses.

In this research study, the investigators are studying the effects of lamivudine on this type of cancer. This drug may help prevent the growth and spread of the cancer cells to other parts of the body. The investigators have discovered that this particular type of colon cancer, which has a p53 mutation may be sensitive to treatment with lamivudine by impairing the ability of the cancer cells to grow.

A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan or MRI, complete response (CR) is the disappearance of all target lesions and partial response (PR) is a \>/=30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.

Progression-Free Survival (PFS) is defined as the time from registration to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation.

Overall Survival (OS) is defined as the time from registration to death due to any cause, or censored at date last known alive.

Disease control rate (DCR) is a composite of overall response rate (ORR) and stable disease and is useful to measure the efficacy of therapies that have tumoristatic effects rather than tumoricidal effects.

Massachusetts General Hospital

Principal Investigator

Adverse events were evaluated through regular investigator assessment and regular laboratory testing.

* Lamivudine administered orally every 4 weeks
* Treatment cycles will last 28 consecutive days
* The dosage will be determine by the PI

Lamivudine: This drug may help prevent the growth and spread of the cancer cells to other parts of the body.

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Aparna Parikh, MD

Overall Response Rate

Of the 32 analyzed participants, 5 participants were censored in PFS analysis because they were taken off treatment before their first radiographic progression.

Progression Free Survival

Overall Survival

Overall Disease Control Rate

Overall Study

Blood and Lymph Conditions

Immune System Diseases

Infections

Symptoms and General Pathology

Rare Diseases

Lymphoma

Hepatitis A

Hepatitis

Hepatitis B

Virus Diseases

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Liver Diseases

Hepatitis, Viral, Human

Communicable Diseases

Enterovirus Infections

Picornaviridae Infections

RNA Virus Infections

Blood-Borne Infections

Hepadnaviridae Infections

DNA Virus Infections

Lymphosarcoma

Herpes Simiae (B Virus)

Entecavir

Ye Guo, MD

The aim of this study is to prove the superiority of entecavir over lamivudine for preventing the risk of hepatitis B virus reactivation in patients with non-Hodgkin lymphoma on CHOP/R-CHOP.

In china, previous studies showed patients with non-Hodgkin lymphoma (NHL) are likely to have hepatitis B virus (HBV) infection. The risk of HBV reactivation is high when patients were treated with CHOP, especially in combination with rituximab. The aim of this study is to compare entecavir with lamivudine, 2 commonly used anti-virus agents, for preventing the risk of HBV reactivation in patients with NHL on CHOP/R-CHOP.

Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Reactivation in NHL

Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Virus Reactivation in Patients With Non-Hodgkin Lymphoma on CHOP/R-CHOP: a Randomized Phase II Study

Defined by increased level of alanine transaminase

Measured by information of treatment delay

Measured by information of HBV DNA level normalization

Fudan University

Recurrence

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Disease Attributes

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Fibrinolytic Agents

Analgesics

Platelet Aggregation Inhibitors

Hematinics

Aspirin

Liver Extracts

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Zheng-Gang Ren, Ph.D

Lan Zhang, Ph.D

Lan Zhang, Master

Zhenggang Ren, Ph.D

Evaluation the Treatment Outcome of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery.

The investigators conduct this clinical trial to evaluate the treatment outcome of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery.The primary outcome is overall survival and objective response rate.

Clinical Study of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery

Liver Cancer Institiute ,Fudan University

chief of departement

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

Ritonavir

Abacavir

Temozolomide

HIV Protease Inhibitors

Protease Inhibitors

Cytochrome P-450 CYP3A Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Participants in this group will undergo Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MR-guided LITT) on Day 0 after stereotactic needle biopsy. On Day 7, participants will begin combination antiretroviral therapy (ART) consisting of Abacavir, Lamivudine, and dose escalation/de-escalation of Ritonavir (RTV), to determine the recommended Phase 2 dose (RP2D) of Ritonavir. Participants will receive up to 12 months of ART.

Beginning Day 14 through Day 180, participants will receive adjuvant therapy, standard of care consisting of focal radiotherapy and Temozolomide therapy. Participants will receive focal radiotherapy for six weeks (42 days). Participants will be administered Temozolomide up to Day 180.

Participants will receive up to 12 months of study therapy, followed by up to 12 months of follow-up. Total participation duration is up to 24 months.

Participants in this group will undergo Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MR-guided LITT) after biopsy on Day 0. On Day 7, participants will begin combination antiretroviral therapy (ART) consisting of Abacavir, Lamivudine, and the recommended phase 2 dose (RP2D) of Ritonavir determined in Part 1. Participants will receive up to 12 months of ART.

Beginning Day 14 through Day 180, participants will receive adjuvant therapy, standard of care consisting of focal radiotherapy and Temozolomide therapy. Participants will receive focal radiotherapy for six weeks (42 days), and Temozolomide therapy, during and following radiotherapy up to Day 180.

Participants will receive up to 12 months of study therapy, followed by up to 12 months of follow-up. Total participation duration is up to 24 months.

Total participation is approximately two years.

Participants will be administered MR-guided Laser Interstitial Thermal Therapy (LITT) as a single procedure, following stereotactic needle biopsy.

Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT)

Participants will take one 600mg tablet of Abacavir orally once daily, as part of combination antiretroviral therapy (ART).

Participants will take one 300mg tablet of Lamivudine orally once daily, as part of combination antiretroviral therapy (ART)

Participants will take one tablet of Ritonavir (RTV) orally twice daily, as part of combination antiretroviral therapy (ART), at one of the following dose levels:

* Dose Level -1: 100mg
* Dose Level 1 (starting dose): 300mg
* Dose Level 2: 450mg
* Dose Level 3: 600mg

Participants will take Temozolomide (TMZ) via capsule orally, during and after focal radiotherapy, as part of standard of care adjuvant therapy. During focal radiotherapy, Temozolomide will be administered at a dose of 75 mg/m2 once daily for six weeks (42 days) on a continuous dosing regimen, including weekends and holidays. After completion of focal radiotherapy, Temozolomide will be administered 150-200 mg/m2 on days 1 through 5 of a four-week cycle for a total of six cycles of maintenance therapy.

Participants will be administered focal radiotherapy for six weeks (42 days), as part of adjuvant therapy, at a total dose of 50-60 grays (Gy) in 1.8-2.0 Gy fractions, depending on prognosis and as determined by the treating radiation oncologist.

Focal Radiotherapy

Ashish Shah, MD

Macarena De La Fuente, MD

The purpose of this study is to determine whether newly diagnosed high-grade glioma(s) that cannot be removed surgically change as a result of the study treatment; and to identify and evaluate the potential side effects (good and bad) of the study treatment in patients with newly diagnosed high-grade glioma(s) that cannot be removed surgically.

Phase 1 dose escalation/de-escalation and dose expansion design.

STARLITE for Unresectable High-Grade Gliomas

Synergistic Treatment With Antiretrovirals and Laser Interstitial Thermal thErapy (STARLITE) for Unresectable High-Grade Gliomas: A Phase 1 Study

The number of participants experiencing dose-limiting toxicity (DLT) during the first 28 days of antiretroviral therapy (ART) will be reported. Toxicity will be assessed by the treating physician and assigned severity and attribution using the National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0 (NCI CTCAE v6.0).

The number of participants experiencing serious adverse events (SAEs) and Grade 3 or higher adverse events (AEs) will be reported. SAEs and AEs will be assessed by the treating physician and assigned severity and attribution using the National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0 (NCI CTCAE v6.0).

PFS is defined as percentage of participants without disease progression at time of study discontinuation.

Overall Survival is defined as the percentage of participants who are still living at the time of study discontinuation.

Medtronic

University of Miami

Assistant Professor of Clinical

Fenbendazole

Roger K C Ngan, Dr

Patients with non-lymphoma and non-leukaemia cancer who are also hepatitis B carriers will have a risk of hepatitis B reactivation during chemotherapy. Lamivudine can be used effectively to control hepatitis upon reactivation during chemotherapy and the chemotherapy may not need to be interrupted. The study aims to investigate whether adding the anti-viral drug Lamivudine at the start of chemotherapy for all patients, rather than at the time of hepatitis reactivation for those with reactivation, will help to improve the delivery of chemotherapy in these patients.

A Study to Investigate Whether the Immediate Use or Deferred Use of an Anti-viral Drug Lamivudine Will Help to Better Safe-guard the Delivery of Chemotherapy in Patients With Cancer Who Are Also Hepatitis B Carriers

A Randomized Controlled Study Comparing the Impact of Prophylactic Versus Deferred Lamivudine on the Delivery of Cytotoxic Chemotherapy in Hepatitis B Surface-antigen Positive Patients With Malignant Solid Tumor

Hospital Authority, Hong Kong

LAM (100 mg/day) will be started within 1 week prior to initiation of the 1st cycle of chemotherapy, and continued until 24 weeks after completion of the last chemotherapy.

ETV (0.5 mg/day) will be started within 1 week prior to initiation of the 1st cycle of chemotherapy, and continued until 24 weeks after completion of the last chemotherapy.

Sook-Hyang Jeong, MD, PhD

Patients with chronic hepatitis B who are undergoing anticancer chemotherapy are at risk of HBV reactivation and hepatitis flare. Lamivudine (LAM) prophylaxis has been recommended in such circumstance according to the practice guidelines despite of limited evidence. However, failure of LAM prophylaxis including virologic breakthrough and withdrawal hepatitis occurs occasionally, which may lead to liver-related morbidity and mortality as well as premature interruption or a delay of chemotherapy. Given relatively frequent drug resistance of LAM, studies on the proper prophylactic antiviral regimen is warranted. The present multicenter, prospective, randomized study aims to compare the effect of entecavir (ETV) versus LAM for the prevention of HBV reactivation in HBsAg-positive patients with hematologic and oncologic malignancy undergoing cytotoxic chemotherapy.

Chronic hepatitis B virus (HBV) carriers who are undergoing anticancer chemotherapy are at risk of HBV reactivation and hepatitis flare, and lamivudine (LAM) prophylaxis is recommended according to the practice guidelines despite of limited evidence. However, failure of LAM prophylaxis defined as virologic breakthrough during LAM therapy and withdrawal hepatitis after discontinuation of LAM therapy occurs occasionally, which may lead to liver-related morbidity and mortality as well as premature interruption or a delay of chemotherapy. Considering that LAM therapy showed relatively higher rates of drug resistance and of withdrawal hepatitis, studies on the better choice of prophylactic antiviral regimen is warranted.

The purpose of our study is to conduct a multicenter, prospective, randomized study comparing the effect of entecavir (ETV) versus LAM for the prevention of HBV reactivation in HBsAg-positive patients with hematologic and oncologic malignancy undergoing cytotoxic chemotherapy.

A total one hundred eighty HBV carriers with malignancy undergoing chemotherapy will be randomly assigned to each prophylactic therapy arm of ETV and LAM group. The primary endpoint of the study is the HBV reactivation rate during antiviral therapy and 6 months after discontinuation of prophylactic antiviral therapy.

If the prophylactic efficacy of ETV is superior to that of LAM, ETV will be the preferred prophylactic therapy for HBsAg-positive cancer patients undergoing chemotherapy.

Comparison of Prophylactic Antiviral Efficacy in Patients Undergoing Chemotherapy: Entecavir Versus Lamivudine

A Randomized, Open Labeled, Multicenter Study Comparing Entecavir Versus Lamivudine as Antiviral Prophylaxis for Patients With Hepatitis B Infection Undergoing Cytotoxic Chemotherapy for Malignant Tumors

10-fold or more elevation in serum HBV DNA titers above nadir

greater than 3-fold increase of ULN (upper limit of a normal reference value) of a serum ALT level that exceeded 100 IU/L during antiviral prophylaxis and 24 week after discontinuation of antiviral prophylaxis

detection of mutations that have been shown in in vitro studies to confer resistance to either ETV or LAM

Seoul National University Hospital

Associate Professor

Respiratory Tract (Lung and Bronchial) Diseases

Small Cell Lung Carcinoma

Carcinoma, Small Cell

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Small Cell Lung Cancer

Dermatologic Agents

Atezolizumab

Carboplatin

Etoposide

Etoposide phosphate

Podophyllotoxin

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Immunologic Factors

Keratolytic Agents

Tubulin Modulators

Antimitotic Agents

INDUCTION: Patients receive lamivudine PO QD on days 1-28. Patients also receive carboplatin IV over 30-60 minutes and atezolizumab IV on day 1, and etoposide IV over 60-120 minutes on days 1-3. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients receive lamivudine PO QD on days 1-28 and atezolizumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

NOTE: Patients who are not eligible for atezolizumab as outlined in exclusion criteria or who refuse to receive atezolizumab may still be treated in this study with carboplatin and etoposide as the IV drug component, in addition to lamivudine orally administered.

Grace K. Dy

Grace K Dy

This phase II trial studies the effect of lamivudine in combination with standard of care chemoimmunotherapy in treating patients with extensive stage small cell lung cancer. Even though small cell lung cancer is initially highly responsive to first-line chemotherapy treatment, treatment resistance inevitably emerges; treatment resistance is when tumor cells stop responding to a drug treatment that they had previously responded to. Lamivudine is an oral antiviral a drug that may be able to reduce the ability of tumors to develop drug resistance. Chemotherapy drugs, such as carboplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lamivudine together with the usual standard of care chemoimmunotherapy may help prevent the growth and spread of the tumor cells to other parts of the body.

PRIMARY OBJECTIVE:

I. To evaluate the 6-month progression-free survival (PFS) rate of lamivudine in combination with platinum-based chemotherapy in patients with extensive stage small cell lung cancer (SCLC).

SECONDARY OBJECTIVES:

I. To evaluate the 12-month survival and overall survival (OS) of patients with extensive stage SCLC receiving study treatment.

II. To assess the toxicity of the combination of lamivudine with platinum-based chemotherapy in this population.

EXPLORATORY OBJECTIVE:

I. To study tissue and blood-based biomarkers as potential predictors of treatment efficacy.

OUTLINE:

INDUCTION: Patients receive lamivudine orally (PO) once daily (QD) on days 1-28. Patients also receive carboplatin intravenously (IV) over 30-60 minutes and atezolizumab IV on day 1, and etoposide IV over 60-120 minutes on days 1-3. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients receive lamivudine PO QD on days 1-28 and atezolizumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

NOTE: Patients who are not eligible for atezolizumab as outlined in exclusion criteria or who refuse to receive atezolizumab may still be treated in this study with carboplatin and etoposide as the IV drug component, in addition to lamivudine orally administered.

After completion of study treatment, patients are followed up for 30 days and then every 60 days thereafter.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer	NCT03144804	Colorectal Canc...	Lamivudine	18 Years -	Massachusetts General Hospital
Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Reactivation in NHL	NCT01914744	Non-Hodgkin Lym... Hepatitis B Rea...	Entecavir Lamivudine	18 Years - 80 Years	Fudan University
Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Reactivation in NHL	NCT01914744	Non-Hodgkin Lym... Hepatitis B Rea...	Entecavir Lamivudine	18 Years - 80 Years	Fudan University
A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer	NCT03144804	Colorectal Canc...	Lamivudine	18 Years -	Massachusetts General Hospital
Clinical Study of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery	NCT01936233	Hepatocellular ... Recurrence	Aspirin Lamivudine	18 Years - 75 Years	Fudan University
STARLITE for Unresectable High-Grade Gliomas	NCT06428045	High Grade Glio...	Magnetic Resona... Abacavir Lamivudine Ritonavir Temozolomide Focal Radiother...	18 Years -	University of Miami
A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer	NCT03144804	Colorectal Canc...	Lamivudine	18 Years -	Massachusetts General Hospital
A Study to Investigate Whether the Immediate Use or Deferred Use of an Anti-viral Drug Lamivudine Will Help to Better Safe-guard the Delivery of Chemotherapy in Patients With Cancer Who Are Also Hepatitis B Carriers	NCT00516945	Hepatitis B Neoplasms	Lamivudine	18 Years - 75 Years	Hospital Authority, Hong Kong
A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer	NCT03144804	Colorectal Canc...	Lamivudine	18 Years -	Massachusetts General Hospital
Comparison of Prophylactic Antiviral Efficacy in Patients Undergoing Chemotherapy: Entecavir Versus Lamivudine	NCT01580202	Malignancy Hepatitis B	Entecavir Lamivudine	18 Years -	Seoul National University Hospital
Lamivudine in Combination With Chemoimmunotherapy for the Treatment of Extensive Stage Small Cell Lung Cancer	NCT04696575	Extensive Stage...	Atezolizumab Carboplatin Etoposide Lamivudine	18 Years -	Roswell Park Cancer Institute
Safety & Efficacy of Lamivudine & Tenofovir to Lower Plasma Level of Viral RNA in Lymphoma	NCT01528865	Lymphoma	Lamivudine Tenofovir disop...	18 Years -	University of Michigan Rogel Cancer Center

Spots Global Cancer Trial Database for lamivudine

Every month we try and update this database with for lamivudine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for lamivudine

Every month we try and update this database with for lamivudine cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for lamivudine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.