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Virus Therapy
SBRT for Non-Small Cell Lung Cancer (STOMP Trial)
Phase 2
Waitlist Available
Led By Jenny Chang, MD
Research Sponsored by The Methodist Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after confirmed disease progression or starts a new therapy, the subject moves into the survival follow-up to be contacted every 12 weeks to assess for survival status until death, withdrawal, or end of study. median duration of follow-up was 8.3 months.
Awards & highlights
STOMP Trial Summary
This trial is testing a new cancer treatment that uses radiation and a virus to kill cancer cells.
Eligible Conditions
- Non-Small Cell Lung Cancer
- Breast Cancer
STOMP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after confirmed disease progression or starts a new therapy, the subject moves into the survival follow-up to be contacted every 12 weeks to assess for survival status until death, withdrawal, or end of study. median duration of follow-up was 8.3 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after confirmed disease progression or starts a new therapy, the subject moves into the survival follow-up to be contacted every 12 weeks to assess for survival status until death, withdrawal, or end of study. median duration of follow-up was 8.3 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate
Secondary outcome measures
Antitumor Activity
Clinical Benefit Rate
Duration of Response
+3 moreOther outcome measures
Change in Immunohistochemical Expression of Tumor-infiltrating Lymphocytes in Tumor Biopsy Tissues
Computed Tomography-based Response of a Non-target Lesion
STOMP Trial Design
1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment4 Interventions
ADV/HSV-tk (5 x 1011 virus particles) in a 2-mL total volume will be injected intratumorally on Day 0.
Valacyclovir will be orally administered at a dose of 2 g three times daily for 14 days from Day 1 to Day 15.
SBRT of 30 Gy (6 Gy X 5 fractions) will be administered over 2 weeks from Day 2 to Day 16.
Pembrolizumab (200 mg) will be administered intravenously over 30 minutes every 3 weeks starting on Day 17 and continuing until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SBRT
2014
Completed Phase 2
~1060
Pembrolizumab
2017
Completed Phase 2
~2010
Valacyclovir
2008
Completed Phase 4
~2520
ADV/HSV-tk
2017
Completed Phase 2
~60
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,514 Total Patients Enrolled
The Methodist Hospital Research InstituteLead Sponsor
271 Previous Clinical Trials
80,318 Total Patients Enrolled
Jenny Chang, MDPrincipal InvestigatorHouston Methodist Cancer Center
5 Previous Clinical Trials
158 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- For breast cancer, your cancer has come back or is not responding to standard treatments. For lung cancer, you have either not received immunotherapy or chemotherapy before, or you have received only one cycle of chemotherapy containing platinum. If you have lung cancer and do not have specific gene mutations, or if you have those mutations but have not responded to targeted therapies, you can also participate.You have other health conditions like diabetes, Parkinson's disease or HIV that may cause a prolonged QT interval, which is a measure of heart function.You have previously received gene vector therapy.You have had alcohol problems or consumed too much alcohol within the last 12 months.You agree to provide tissue samples for the study.You are expected to live for at least six more months.You or someone in your family has had unexplained fainting or sudden death.You are able and agree to give written permission to participate in the trial.Your blood has enough white blood cells called neutrophils, which help fight infections.You must be 18 years or older when you sign the consent form.Your white blood cell count should be between 2,500 and 15,000 cells per microliter.You have a mental health or drug abuse issue that may make it difficult for you to follow the requirements of the trial.You have received a specific type of medication called anti-PD-1, anti-PD-L1, or anti-PD-L2, which is not allowed for the TNBC group.You have received immunotherapy or immunomodulatory therapy before (applies to those in the TNBC group).You are able to perform daily activities and take care of yourself without help, or with minimal help.Your tumor is either too small or too large for the type of radiation treatment being studied.You are currently taking part in another study using experimental medication or equipment, or have done so in the past 4 weeks.You have at least one tumor that can be measured and is at least 1 cm in diameter. You also have another tumor that is at least 1 cm in diameter for evaluation purposes.Your blood platelet count is at least 100,000 per microliter.Your hemoglobin level is at least 8 g/dL or 5.6 mmol/L without the need for blood transfusion or erythropoietin medication for at least 7 days before assessment.You are allergic to pembrolizumab or any of the other ingredients in the treatment.You have a history of gallbladder or bile duct disease or have had pancreatitis.If you have mild neuropathy (Grade 2 or lower), you may still be eligible for the study.You have another type of cancer that is getting worse or needs treatment, except for certain types of skin cancer or early stage cervical cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Single arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum number of participants in this experiment?
"Unfortunately, enrollment for this trial is closed. First posted on July 1st 2017 and last updated on July 7th 2022, the study has finished recruiting patients. If you are looking to participate in other trials, there are currently 4189 studies focusing on breast cancer which need participants, as well as 971 active SBRT clinical trials."
Answered by AI
Has a similar study of this nature ever been conducted prior?
"Worldwide, 971 active clinical trials for SBRT are present in 3008 cities and 63 countries. The origin of this research dates back to 2006 when Millennium Pharmaceuticals, Inc. conducted a Phase 2 trial with 46 patients at its centre; since then, 331 studies have concluded their investigations."
Answered by AI
To what maladies is stereotactic body radiation therapy regularly deployed?
"Stereotactic body radiation therapy (SBRT) is the most common method of treatment for patients with unresectable melanoma. SBRT has also been proven to be a viable option for those facing microsatellite instability high, elevated recurrence risk, and diseases of similar nature."
Answered by AI
Is there a recruitment process for participants of this experiment currently in progress?
"Unfortunately, this trial is not currently conducting recruitment. It was initially posted on July 1st 2017 and last amended on July 7th 2022. If you're pursuing other medical trials, there are over 4100 studies looking for breast cancer patients and just under 1000 in need of SBRT participants."
Answered by AI
What earlier experiments have been conducted concerning stereotactic body radiotherapy?
"At this time, the number of ongoing clinical trials for Stereotactic Body Radiation Therapy sits at 971. Of these studies, 123 are in Phase 3 and 35925 different sites have been established to conduct them. The majority of SBRT research is conducted out of Houston, Texas."
Answered by AI
What are the potential adverse effects of stereotactic body radiation therapy (SBRT)?
"SBRT has been deemed safe based on the Phase 2 trial data, earning it a score of 2. Unfortunately, there is no available clinical evidence to suggest its efficacy as of yet."
Answered by AI
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