Intraperitoneal LSTA1 in CRS-HIPEC

Last updated: August 16, 2024
Sponsor: University of California, San Diego
Overall Status: Trial Not Available

Phase

1

Condition

Colorectal Cancer

Colon Cancer; Rectal Cancer

Rectal Cancer

Treatment

CRS-HIPEC + LSTA1

CRS-HIPEC alone

Clinical Study ID

NCT06216561
UCSD 807804
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Provision of signed and dated informed consent form.

  2. Stated willingness to comply with all study procedures and availability for theduration of the study.

  3. Participants must have histologically confirmed non-mucinous (< 50% mucin)colorectal, ovarian, or appendiceal carcinoma with peritoneal metastases who arecandidates for (cytoreductive surgery and CRS-HIPEC and have at least one peritonealtumor nodule > 5 mm (as determined by routine preoperative imaging and confirmed byintraoperative assessment).

  4. Eligible and intended to undergo CRS-HIPEC per the investigators. This includesassessment of axial imaging (computed tomography, magnetic resonance imaging,positron emission tomography scan) of chest, abdomen, and pelvis, within 30 days ofscreening, which reveals peritoneal metastases amenable to complete cytoreductionper the investigators (i.e. limited small bowel/mesenteric metastases), lack ofextra-peritoneal metastases (including intra-hepatic and pulmonary metastases), andlack 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 undergoingCRS-HIPEC.

  8. Adequate contraception for participants able to cause a pregnancy:

Exclusion

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 ofCRS-HIPEC.

  3. Active infection (viral, fungal, or bacterial) requiring systemic therapy.

  4. Known active hepatitis B virus (HBV), hepatitis C virus (HCV), tuberculosis, orhuman immunodeficiency virus (HIV) infection.

  5. History of allogeneic tissue/solid organ transplant.

  6. History or clinical evidence of central nervous system (CNS) metastases withoutexceptions

  7. History of allergic reactions attributed to compounds of similar chemical orbiologic composition to LSTA1 or other agents used in the study, including thosediscovered 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, butis not limited to the following laboratory values and other parameters within 30days prior to planned date of CRS-HIPEC:

  10. Platelets < 100,000/mm3

  11. White blood cell count < 3000/ mm3

  12. Absolute neutrophil count < 1,500/mm3

  13. Serum albumin < 2.5 g/L

  14. Alanine transaminase (ALT) and aspartate aminotransferase (AST) > 2.5 x upperlimit of normal (ULN) in the absence of liver metastases or > 5 x ULN in thepresence of liver metastases

  15. Bilirubin > 1.5 x ULN

  16. Glomerular Filtration Rate (per Modification of Diet in Renal Disease equation) < 30 mL/min

  17. Hemoglobin < 9.0 g/dL (drawn 24 hours after a transfusion, if relevant)

  18. International normalised ratio (INR) > 2.0 (for patients not receivingtherapeutic anticoagulation)

  19. Adequate respiratory and cardiac function (PaO2 ≥ 60 mm Hg or oxygen saturation ≥ 92% on room air, and 12-lead electrocardiogram (ECG) with normal tracing orQT interval < 470 ms)

  20. Participants who are pregnant or nursing.

Study Design

Treatment Group(s): 2
Primary Treatment: CRS-HIPEC + LSTA1
Phase: 1
Study Start date:
November 30, 2023
Estimated Completion Date:
June 24, 2024

Study 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.

Connect with a study center

  • University of California San Diego

    La Jolla, California 92093
    United States

    Site Not Available

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