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LSTA1 + Standard Care for Advanced Cancers (BOLSTER Trial)
Phase 2
Recruiting
Research Sponsored by Lisata Therapeutics, Inc.
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 30 days after treatment discontinuation
Awards & highlights
BOLSTER Trial Summary
This trial tests a new drug plus standard treatment vs. standard treatment alone in advanced cancer patients.
Who is the study for?
This trial is for adults with advanced head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, or cholangiocarcinoma. They must have progressed after first-line therapy, be expected to live at least 3 months, have good organ function and performance status. Exclusions include recent major surgery or radiation, active infections including hepatitis B/C or HIV, certain autoimmune diseases, other cancers treated within the last 3 years, significant heart disease within the past 6 months.Check my eligibility
What is being tested?
The study tests a new drug called LSTA1 added to standard cancer treatments (like Gemcitabine and Cisplatin) versus just the standard treatments alone. It aims to find out if adding LSTA1 is safe and improves outcomes compared to standard care in patients with specific types of advanced solid tumors.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as inflammation in different body parts due to Durvalumab (an immunotherapy), plus typical chemotherapy side effects like nausea, fatigue, hair loss from drugs like Docetaxel and Paclitaxel.
BOLSTER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days after treatment discontinuation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after treatment discontinuation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
BOLSTER Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: LSTA1 arm for CholangiocarcinomaExperimental Treatment4 Interventions
Group II: LSTA1 arm for Advanced Head and Neck Squamous Cell CarcinomaExperimental Treatment2 Interventions
Group III: Placebo arm for Advanced Head and Neck Squamous Cell CarcinomaPlacebo Group2 Interventions
Group IV: Placebo arm for CholangiocarcinomaPlacebo Group4 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Paclitaxel
2011
Completed Phase 4
~5380
Durvalumab
2017
Completed Phase 2
~3870
Gemcitabine
2017
Completed Phase 3
~2070
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Who is running the clinical trial?
Lisata Therapeutics, Inc.Lead Sponsor
15 Previous Clinical Trials
1,262 Total Patients Enrolled
Kristen K Buck, MDStudy ChairLisata Therapeutics, Inc.
3 Previous Clinical Trials
73 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had active treatment for another cancer in the last 3 years, except for certain curable types.I am allergic to taxanes or their pre-treatments for head and neck cancer.I do not have active tuberculosis.I have symptoms from cancer spread to my brain or spinal cord.I am fully active or can carry out light work.My cancer is in my head or neck, has returned or spread, and didn't respond to initial immunotherapy.I have not had major surgery or radiation in the last 4 weeks.I have cholangiocarcinoma and an autoimmune disease, but it's controlled without immunosuppressive drugs.I am currently being treated for a serious infection.I have received an organ or tissue transplant from another person.I haven't had serious heart or stroke issues in the last 6 months.My organs and bone marrow are working well.My cancer is in the bile duct or gallbladder, can't be removed by surgery, and I haven't had any previous systemic treatments.I do not have active hepatitis B, C, or HIV.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo arm for Advanced Head and Neck Squamous Cell Carcinoma
- Group 2: Placebo arm for Cholangiocarcinoma
- Group 3: LSTA1 arm for Advanced Head and Neck Squamous Cell Carcinoma
- Group 4: LSTA1 arm for Cholangiocarcinoma
Awards:
This trial has 0 awards, including: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.
How many individuals are eligible to partake in this experiment?
"Affirmative. Clinicaltrials.gov clearly states that this research project, which was first published in April 2021, is presently seeking participants from 1 medical institution to fill the 120 open spots."
Answered by AI
Is the LSTA1 protocol for treating Advanced Head and Neck Squamous Cell Carcinoma officially validated by the FDA?
"Considering the Phase 2 clinical trial status of LSTA1 arm for Advanced Head and Neck Squamous cell carcinoma, our team at Power has rated its safety with a score of 2 due to preliminary data on its security but no evidence that it is effective."
Answered by AI
Are applications for participation currently being accepted?
"Affirmative. According to information from clinicaltrials.gov, this medical trial is actively recruiting candidates for participation. The first posting was on April 1st 2023 and it has most recently been updated on April 19th 2023. 120 patients are needed at a single site in order to complete the study's objectives."
Answered by AI
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