Colorectal CancerPhase 1NCT06216561
Intraperitoneal LSTA1 in CRS-HIPEC
A Phase 1 study testing CRS-HIPEC + LSTA1 and CRS-HIPEC alone in people with Colorectal Cancer and Ovarian Carcinoma, run by University of California, San Diego at 1 site in United States.
Trial summary
This Study is designed to test an investigational product (IP) called LSTA1 (Study drug). LSTA1 is a drug designed to improve the delivery of anti-cancer treatments, such as chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Ovarian Carcinoma, Appendix Cancer
- What is being tested?
- CRS-HIPEC + LSTA1 and CRS-HIPEC alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2023to 24 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Participants must have histologically confirmed non-mucinous (< 50% mucin) colorectal, ovarian, or appendiceal carcinoma with peritoneal metastases who are candidates for (cytoreductive surgery and CRS-HIPEC and have at least one peritoneal tumor nodule > 5 mm (as determined by routine preoperative imaging and confirmed by intraoperative assessment).
- Eligible and intended to undergo CRS-HIPEC per the investigators. This includes assessment of axial imaging (computed tomography, magnetic resonance imaging, positron emission tomography scan) of chest, abdomen, and pelvis, within 30 days of screening, which reveals peritoneal metastases amenable to complete cytoreduction per the investigators (i.e. limited small bowel/mesenteric metastases), lack of extra-peritoneal metastases (including intra-hepatic and pulmonary metastases), and lack of untreated biliary, gastrointestinal, and urologic obstruction.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status < 2.
- Women of child-bearing potential with negative pregnancy test prior to undergoing CRS-HIPEC.
- Adequate contraception for participants able to cause a pregnancy:
Who cannot join
- Participants who do not receive HIPEC at the time of CRS.
- Any major surgery or irradiation within 30 days prior to prior to planned date of CRS-HIPEC.
- Active infection (viral, fungal, or bacterial) requiring systemic therapy.
- Known active hepatitis B virus (HBV), hepatitis C virus (HCV), tuberculosis, or human immunodeficiency virus (HIV) infection.
- History of allogeneic tissue/solid organ transplant.
- History or clinical evidence of central nervous system (CNS) metastases without exceptions
Show all 20Show fewer
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to LSTA1 or other agents used in the study, including those discovered by other ongoing studies of LSTA1 or other agents used in the study.
- Existing venous thromboembolism at the time of CRS-HIPEC.
- Severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to undergo CRS-HIPEC and receive study treatment. This includes, but is not limited to the following laboratory values and other parameters within 30 days prior to planned date of CRS-HIPEC:
- Platelets < 100,000/mm3
- White blood cell count < 3000/ mm3
- Absolute neutrophil count < 1,500/mm3
- Serum albumin < 2.5 g/L
- Alanine transaminase (ALT) and aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN) in the absence of liver metastases or > 5 x ULN in the presence of liver metastases
- Bilirubin > 1.5 x ULN
- Glomerular Filtration Rate (per Modification of Diet in Renal Disease equation) < 30 mL/min
- Hemoglobin < 9.0 g/dL (drawn 24 hours after a transfusion, if relevant)
- International normalised ratio (INR) > 2.0 (for patients not receiving therapeutic anticoagulation)
- Adequate respiratory and cardiac function (PaO2 ≥ 60 mm Hg or oxygen saturation ≥ 92% on room air, and 12-lead electrocardiogram (ECG) with normal tracing or QT interval < 470 ms)
- Participants who are pregnant or nursing.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
La Jolla, California, 92093
About this study
Official title: A Phase I Trial of Intraperitoneal LSTA1 in Patients Undergoing Cytoreductive Surgery and HIPEC for Peritoneal Surface Malignancy
This Study is designed to test an investigational product (IP) called LSTA1 (Study drug). LSTA1 is a drug designed to improve the delivery of anti-cancer treatments, such as chemotherapy. Improved delivery of chemotherapy may result in improved anti-cancer effects when given with hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal metastases. Participants will be randomized to receive LSTA1 with HIPEC or HIPEC alone (without LSTA1) at the time of surgery.
Read the detailed description
Given the high recurrence and disease-related mortality in patients with peritoneal metastases from appendiceal, colorectal, and ovarian cancer after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC), use of an agent to improve operative tumor delivery of co-administered anticancer drugs during HIPEC would potentially have significant impact on oncologic outcomes.
Safety of LSTA1 has been demonstrated in the context of metastatic pancreatic cancer when administered intravenously with cytotoxic chemotherapy, but the investigators wish to determine its safety and potential efficacy when administered intraperitoneally with HIPEC in patients with peritoneal metastases from appendiceal, colorectal, and ovarian cancer.
- Being tested
- CRS-HIPEC + LSTA1, CRS-HIPEC alone
- Medical subject headings
- Colorectal Neoplasms, Ovarian Neoplasms, Appendiceal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRS-HIPEC + LSTA1Drug
Also called Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) + Advanced Solid TumorsCertepetide (LSTA1)
LSTA1 given with hyperthermic intraperitoneal chemotherapy (HIPEC) at time of cytoreductive surgery (CRS)
CRS-HIPEC aloneProcedure or surgery
Hyperthermic intraperitoneal chemotherapy (HIPEC) alone (without LSTA1) at time of cytoreductive surgery (CRS)
| Study group | Role | What they receive |
|---|---|---|
| CRS-HIPEC + LSTA1 | Experimental | Experimental Arm Receives: Drug: CRS-HIPEC + LSTA1 |
| CRS-HIPEC alone | Active comparator | Control Arm Receives: Procedure: CRS-HIPEC alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events of interest (AE-I)
The proportion of subjects experiencing an inpatient adverse event of interest (AE-I; gastrointestinal fistula/leak, neutropenia, intra-abdominal abscess, venous thromboembolism, mortality)
Measured: postoperatively from the date of CRS-HIPEC to date of discharge (typically 1-2 weeks)
Drug concentration in tumor
Total drug content in tumor, divided by total tumor mass
Measured: at time of surgery
Secondary outcomes (2)
Progression-Free Survival and Overall Survival
Time (in months) from randomization to time of progression or death due to any cause, whichever occurs first (PFS), or to time of death due to any cause (OS).
Measured: 5 years
Adverse Events (AEs)
Incidence of any adverse events (AEs) by grade and system organ class using CTCAE v5.0 up to 30 days from the date of CRS-HIPEC.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start30 Nov 2023
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Why it stopped: closed early due to low (0) accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Unblinded, randomized 2:1 to CRS-HIPEC + LSTA1 vs. CRS-HIPEC alone
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joel Baumgartner, University of California, San Diego
- Investigators
- Joel Baumgartner, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216561
- Sponsor's protocol ID
- UCSD 807804
- Status last verified
- Aug 2024
- First submitted
- 22 Dec 2023
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Intraperitoneal LSTA1 in Patients Undergoing Cytoreductive Surgery and HIPEC for Peritoneal Surface Malignancy
- ClinicalTrials.gov ID
- NCT06216561
- Acronym / sponsor ID
- UCSD 807804
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: closed early due to low (0) accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Study is designed to test an investigational product (IP) called LSTA1 (Study drug). LSTA1 is a drug designed to improve the delivery of anti-cancer treatments, such as chemotherapy. Improved delivery of chemotherapy may result in improved anti-cancer effects when given with hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal metastases. Participants will be randomized to receive LSTA1 with HIPEC or HIPEC alone (without LSTA1) at the time of surgery.
Detailed description
Given the high recurrence and disease-related mortality in patients with peritoneal metastases from appendiceal, colorectal, and ovarian cancer after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC), use of an agent to improve operative tumor delivery of co-administered anticancer drugs during HIPEC would potentially have significant impact on oncologic outcomes.
Safety of LSTA1 has been demonstrated in the context of metastatic pancreatic cancer when administered intravenously with cytotoxic chemotherapy, but the investigators wish to determine its safety and potential efficacy when administered intraperitoneally with HIPEC in patients with peritoneal metastases from appendiceal, colorectal, and ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Unblinded, randomized 2:1 to CRS-HIPEC + LSTA1 vs. CRS-HIPEC alone
| Arm | Type | Receives |
|---|---|---|
| CRS-HIPEC + LSTA1 | Experimental | Drug: CRS-HIPEC + LSTA1Experimental Arm |
| CRS-HIPEC alone | Active comparator | Procedure: CRS-HIPEC aloneControl Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Participants must have histologically confirmed non-mucinous (< 50% mucin) colorectal, ovarian, or appendiceal carcinoma with peritoneal metastases who are candidates for (cytoreductive surgery and CRS-HIPEC and have at least one peritoneal tumor nodule > 5 mm (as determined by routine preoperative imaging and confirmed by intraoperative assessment).
- Eligible and intended to undergo CRS-HIPEC per the investigators. This includes assessment of axial imaging (computed tomography, magnetic resonance imaging, positron emission tomography scan) of chest, abdomen, and pelvis, within 30 days of screening, which reveals peritoneal metastases amenable to complete cytoreduction per the investigators (i.e. limited small bowel/mesenteric metastases), lack of extra-peritoneal metastases (including intra-hepatic and pulmonary metastases), and lack of untreated biliary, gastrointestinal, and urologic obstruction.
- Age ≥ 18 years.
Key exclusion criteria (20 listed)
- Participants who do not receive HIPEC at the time of CRS.
- Any major surgery or irradiation within 30 days prior to prior to planned date of CRS-HIPEC.
- Active infection (viral, fungal, or bacterial) requiring systemic therapy.
- Known active hepatitis B virus (HBV), hepatitis C virus (HCV), tuberculosis, or human immunodeficiency virus (HIV) infection.
- History of allogeneic tissue/solid organ transplant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRS-HIPEC + LSTA1Also: Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) + Advanced Solid TumorsCertepetide (LSTA1)LSTA1 given with hyperthermic intraperitoneal chemotherapy (HIPEC) at time of cytoreductive surgery (CRS) | Drug | CRS-HIPEC + LSTA1 |
| CRS-HIPEC aloneHyperthermic intraperitoneal chemotherapy (HIPEC) alone (without LSTA1) at time of cytoreductive surgery (CRS) | Procedure or surgery | CRS-HIPEC alone |
Primary outcome
Adverse events of interest (AE-I)
Time frame: postoperatively from the date of CRS-HIPEC to date of discharge (typically 1-2 weeks)
The proportion of subjects experiencing an inpatient adverse event of interest (AE-I; gastrointestinal fistula/leak, neutropenia, intra-abdominal abscess, venous thromboembolism, mortality)
Drug concentration in tumor
Time frame: at time of surgery
Total drug content in tumor, divided by total tumor mass
2 secondary outcomes
Progression-Free Survival and Overall Survival
Time frame: 5 years
Adverse Events (AEs)
Time frame: 30 Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Toripalimab Plus Cetuximab and Irinotecan for Second-Line Right-Sided RAS/BRAF Wild-Type Advanced Colon Cancer Phase II Study
Colorectal Cancer (CRC)
Not yet recruiting
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
Rectal Cancer Patients, Rectal Cancer Surgery
Not yet recruiting
A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced / Metastatic Solid Tumors.
NSCLC (Advanced Non-small Cell Lung Cancer), NSCLC (Non-small Cell Lung Cancer)
Not yet recruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08165784 in People With PIK3CA-Mutated Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Advanced or Metastatic Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Baumgartner principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CRS-HIPEC + LSTA1 and CRS-HIPEC alone in people with Colorectal Cancer and Ovarian Carcinoma, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events of interest (AE-I) (time frame: postoperatively from the date of CRS-HIPEC to date of discharge (typically 1-2 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.