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Pilot Study of Antiviral Treatment in Combination With Low-dose Gemcitabine in EBV-associated Gastric Cancer (EBVaGC)

Primary Purpose

Gastric Cancer

Status

Withdrawn

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Antiviral treatment in combination with low-dose gemcitabine

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients must be ≥20 years of age.
Advanced gastric adenocarcinoma (including GEJ) that has progressed during or after second-line therapy.
The patient's tumor tissue must have the pre-defined characteristics as follows ; EBV+
ECOG performance status 0-1
Patients must have a life expectancy ≥ 4 months from proposed first dose date.
The patient has measureable or evaluable disease as determined by standard computed tomography (CT) or magnetic resonance imaging (MRI) imaging. Examples of evaluable, nonmeasurable disease include gastric, peritoneal, or mesenteric thickening in areas of known disease, or peritoneal nodules that are too small to be considered measurable by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
Patients must have acceptable bone marrow, liver and renal function measured within 28 days prior to administration of study treatment as defined below: WBC ≥ 3,500 cells/mm3 and ≤ 50,000 cells/mm3, ANC ≥ 1,500 cells/mm3, Hemoglobin ≥ 9 g/dL (transfusion allowed), Platelet count ≥ 100,000 /mm3; Total bilirubin ≤ 1.5 X ULN, AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN; Creatinine clearance ≥60 mL/min
Provision of fully informed consent prior to any study specific procedures.

Exclusion Criteria:

The patient has a history severe or unstable heart disease, e.g. coronary artery disease requiring increased dose of anti-anginal medication and/or coronary angioplasty (including stent placement) within 24 months ( congestive heart failure NYHA III or IV, unstable angina, history of myocardial infarction within the last 12 months, clinically significant arrhythmia)
The patient is pregnant or breastfeeding.(For women with pregnancy potential, an effective method of contraception should be agreed.)
The patient has ongoing Uncontrolled systemic diseases (diabetes, hypertension, hypothyroidism, infection, etc.)
The patient has ongoing central nervous system malignancy. (except for lesions that have been completely removed or underwent anterior brain radiotherapy/gamma knife procedure)
The patient has a history of allergic reactions to gemcitabine, Valganciclovir, aciclovir, valacyclovir ganciclovir
Patients with interstitial pneumonia or pulmonary fibrosis with clinical symptoms

Sites / Locations

Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Antiviral treatment in combination with low-dose gemcitabine

Arm Description

For 1st & 2nd cycle D1, 8, 15 Gemcitabine 30-300mg/m2 IV over 30 minutes D8-28 Valganciclovir 900mg qd Every 4 weeks For 3rd ~ 6th cycle D1, 8, 15 Gemcitabine 30-300mg/m2 IV over 30 minutes D1-28 Valganciclovir 900mg qd Every 4 weeks

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)

Modified RECIST 1.1 criteria will be used to assess patient response to treatment by determining PFS and ORR. The modified RECIST 1.1 guidelines for measurable, non-measurable, target and non-target lesions and the objective tumour response criteria

Secondary Outcome Measures

Best Overall Response Rate (BOR)

Full Information

NCT ID

NCT05431244

First Posted

June 13, 2022

Last Updated

October 31, 2022

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05431244

Brief Title

Pilot Study of Antiviral Treatment in Combination With Low-dose Gemcitabine in EBV-associated Gastric Cancer (EBVaGC)

Official Title

Pilot Study of Antiviral Treatment in Combination With Low-dose Gemcitabine in EBV-associated Gastric Cancer (EBVaGC)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Research withdrawal before patient registration due to difficulty in continuing research

Study Start Date

July 1, 2022 (Anticipated)

Primary Completion Date

July 1, 2024 (Anticipated)

Study Completion Date

July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

Epstein-Barr virus (EBV) is a double-stranded DNA human gamma herpes virus that establishes a persistent infection in over 90% of individuals. Most infections are self-limiting, but some cases are associated with the development of malignancies of lymphoid or epithelial origin. EBV-associated gastric carcinomas (EBVaGC) make up about 9% of all stomach cancers. The constant presence of the viral genome in EBVaGC suggests the applicability of novel EBV-targeted therapies. The antiviral nucleoside drug, (val)ganciclovir (GCV), is effective only in the context of the viral lytic cycle in the presence of EBV-encoded thymidine kinase (TK)/ protein kinase (PK) expression. JM Lee et al. reported that gemcitabine was lytic inducer via activation of the ATM/p53 genotoxic stress pathway in EBVaGC and confirmed the efficacy of gemcitabine-GCV combination treatment. So we planned this proof of concept trial to apply the antiviral agent in EBVaGC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Antiviral treatment in combination with low-dose gemcitabine

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

Antiviral treatment in combination with low-dose gemcitabine

Intervention Description

-maximun 6 cycles Gemcitabine; 30mg/m2 or 100mg/m2 or 300mg/m2 D1,D8, D15 (Q 1 week,3 times, rest for 1 week, every 4 weeks ) 1,2 cycle Valganciclovir; 900mg D8~D28 (from 1 week after Gemcitabine iv started, qd, PO, 21days) 3~6cycle Valganciclovir; 900mg D1~D28 (from Gemcitabine start date, PO, 28days)

Primary Outcome Measure Information:

Title

Objective Response Rate (ORR)

Description

Time Frame

up to 24months

Secondary Outcome Measure Information:

Title

Best Overall Response Rate (BOR)

Description

Time Frame

up to 24months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must be ≥20 years of age. Advanced gastric adenocarcinoma (including GEJ) that has progressed during or after second-line therapy. The patient's tumor tissue must have the pre-defined characteristics as follows ; EBV+ ECOG performance status 0-1 Patients must have a life expectancy ≥ 4 months from proposed first dose date. The patient has measureable or evaluable disease as determined by standard computed tomography (CT) or magnetic resonance imaging (MRI) imaging. Examples of evaluable, nonmeasurable disease include gastric, peritoneal, or mesenteric thickening in areas of known disease, or peritoneal nodules that are too small to be considered measurable by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) Patients must have acceptable bone marrow, liver and renal function measured within 28 days prior to administration of study treatment as defined below: WBC ≥ 3,500 cells/mm3 and ≤ 50,000 cells/mm3, ANC ≥ 1,500 cells/mm3, Hemoglobin ≥ 9 g/dL (transfusion allowed), Platelet count ≥ 100,000 /mm3; Total bilirubin ≤ 1.5 X ULN, AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN; Creatinine clearance ≥60 mL/min Provision of fully informed consent prior to any study specific procedures. Exclusion Criteria: The patient has a history severe or unstable heart disease, e.g. coronary artery disease requiring increased dose of anti-anginal medication and/or coronary angioplasty (including stent placement) within 24 months ( congestive heart failure NYHA III or IV, unstable angina, history of myocardial infarction within the last 12 months, clinically significant arrhythmia) The patient is pregnant or breastfeeding.(For women with pregnancy potential, an effective method of contraception should be agreed.) The patient has ongoing Uncontrolled systemic diseases (diabetes, hypertension, hypothyroidism, infection, etc.) The patient has ongoing central nervous system malignancy. (except for lesions that have been completely removed or underwent anterior brain radiotherapy/gamma knife procedure) The patient has a history of allergic reactions to gemcitabine, Valganciclovir, aciclovir, valacyclovir ganciclovir Patients with interstitial pneumonia or pulmonary fibrosis with clinical symptoms

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeeyun Lee, M.D. Ph.D

Organizational Affiliation

Samsung Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Pilot Study of Antiviral Treatment in Combination With Low-dose Gemcitabine in EBV-associated Gastric Cancer (EBVaGC)

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