Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06216561
Other study ID # UCSD 807804
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date November 30, 2023
Est. completion date December 2029

Study information

Verified date January 2024
Source University of California, San Diego
Contact Joel Baumgartner
Phone (858) 246-0581
Email J1baumgartner@health.ucsd.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 21
Est. completion date December 2029
Est. primary completion date December 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. 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). 4. 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. 5. Age = 18 years. 6. Eastern Cooperative Oncology Group (ECOG) performance status < 2. 7. Women of child-bearing potential with negative pregnancy test prior to undergoing CRS-HIPEC. 8. Adequate contraception for participants able to cause a pregnancy: Exclusion Criteria: 1. Participants who do not receive HIPEC at the time of CRS. 2. Any major surgery or irradiation within 30 days prior to prior to planned date of CRS-HIPEC. 3. Active infection (viral, fungal, or bacterial) requiring systemic therapy. 4. Known active hepatitis B virus (HBV), hepatitis C virus (HCV), tuberculosis, or human immunodeficiency virus (HIV) infection. 5. History of allogeneic tissue/solid organ transplant. 6. History or clinical evidence of central nervous system (CNS) metastases without exceptions 7. 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. 8. Existing venous thromboembolism at the time of CRS-HIPEC. 9. 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: 1. Platelets < 100,000/mm3 2. White blood cell count < 3000/ mm3 3. Absolute neutrophil count < 1,500/mm3 4. Serum albumin < 2.5 g/L 5. 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 6. Bilirubin > 1.5 x ULN 7. Glomerular Filtration Rate (per Modification of Diet in Renal Disease equation) < 30 mL/min 8. Hemoglobin < 9.0 g/dL (drawn 24 hours after a transfusion, if relevant) 9. International normalised ratio (INR) > 2.0 (for patients not receiving therapeutic anticoagulation) 10. 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) 10. Participants who are pregnant or nursing.

Study Design


Intervention

Drug:
CRS-HIPEC + LSTA1
LSTA1 given with hyperthermic intraperitoneal chemotherapy (HIPEC) at time of cytoreductive surgery (CRS)
Procedure:
CRS-HIPEC alone
Hyperthermic intraperitoneal chemotherapy (HIPEC) alone (without LSTA1) at time of cytoreductive surgery (CRS)

Locations

Country Name City State
United States University of California San Diego La Jolla California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) postoperatively from the date of CRS-HIPEC to date of discharge (typically 1-2 weeks)
Primary Drug concentration in tumor Total drug content in tumor, divided by total tumor mass at time of surgery
Secondary 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). 5 years
Secondary 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. 30 Days
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Active, not recruiting NCT05551052 - CRC Detection Reliable Assessment With Blood
Completed NCT00098787 - Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT05425940 - Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer Phase 3
Suspended NCT04595604 - Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery. N/A
Completed NCT03414125 - Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening N/A
Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Terminated NCT01847599 - Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib N/A
Completed NCT05799976 - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure N/A
Recruiting NCT03874026 - Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT03181334 - The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation N/A
Completed NCT03167125 - Participatory Research to Advance Colon Cancer Prevention N/A
Recruiting NCT04258137 - Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study N/A
Recruiting NCT05568420 - A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
Recruiting NCT02972541 - Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer N/A
Completed NCT02876224 - Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors Phase 1
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A