SUSPENDED

Intraperitoneal Paclitaxel-loaded TPM for Treatment of Peritoneal Carcinomatosis

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Conditions

Peritoneal Carcinomatosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A first-in-human, unblinded, phase I trial of Paclitaxel-loaded tumor penetrating microparticles (TPM) in peritoneal carcinomatosis patients who are not eligible for standard-of-care therapeutic interventions.

Official Title

Phase I Trial of Intraperitoneal Paclitaxel-loaded Tumor Penetrating Microparticles (TPM) for Treatment of Peritoneal Carcinomatosis

Quick Facts

Study Start:2022-04-26
Study Completion:2026-01-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:SUSPENDED

Study ID

NCT05159050

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability to understand and the willingness to sign a written informed consent document
  2. * Have pathology proven peritoneal carcinomatosis (PC) due to colorectal, ovarian, gastric, pancreatic, appendiceal cancer or mesothelioma, or suspected peritoneal metastasis based on radiological findings. (Patient to come off study if no pathology evidence of peritoneal metastasis at the time of surgery)
  3. * No other standard treatment options are available
  4. * Measurable intraperitoneal disease by RECIST v1.1 criteria , or by radiological PCI scoring when RECIST is not feasible, on imaging studies
  5. * 18 to 75 years of age
  6. * Have an ECOG performance of 0 to 2
  7. * Have adequate organ and bone marrow functions as indicated by:
  8. * Leukocytes ≥ 3000/mcL
  9. * Absolute neutrophil count ≥ 1500/mcL
  10. * Platelets ≥ 100000/mcL
  11. * Total bilirubin within normal institutional limits
  12. * AST (SGOT) \< 3 x institutional upper limit of normal
  13. * ALT (SPGT) \< 3 x institutional upper limit of normal
  14. * Medically fit for surgery. Defined as: Patients who are able to undergo general anesthesia for abdominal surgery and have a metabolic equivalent (METs) ≥ 4
  15. * Have adequate contraception, as follows:
  16. 1. Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 10 months beyond the last dose of TPM. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  17. 2. A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
  18. * has not undergone a hysterectomy or bilateral oophorectomy; or
  19. * has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
  20. * One Barrier method (cervical cap with spermicide plus male condom; diaphragm with spermicide plus male condom) OR
  21. * Hormonal method (oral contraceptives, implants, or injections) or an intrauterine device (e.g., Copper-T)
  1. * Presence of mucinous ascites
  2. * Evidence of extra-peritoneal metastases
  3. * Current or expected use of other investigational agents
  4. * Received systemic chemotherapy or radiotherapy within 3 weeks prior to study enrollment or not recovering from adverse events (e.g., recovery to ≤ Grade 1)
  5. * Abdominal cavity deemed not accessible by treating surgeon due to prior abdominal surgery
  6. * History of allergic reactions to paclitaxel, PLG co-polymer, mannitol, or polysorbate 80
  7. * Uncontrolled intercurrent illness
  8. * Currently active second malignancy other than non-melanoma skin cancer
  9. * Pregnancy, nursing, or plans to become pregnant for the duration of study participation including 10 months beyond the last dose of TPM
  10. * Grade 2 or higher peripheral neuropathy
  11. * CrCL ≤ 4 mL/min
  12. * Actively treated for other malignancy
  13. * Patients with HIV or Hepatitis B/C requiring the use of ART agents

Contacts and Locations

Principal Investigator

Carlos Chan, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Iowa

Study Locations (Sites)

University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
United States

Collaborators and Investigators

Sponsor: Carlos Chan

  • Carlos Chan, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Iowa

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-26
Study Completion Date2026-01-14

Study Record Updates

Study Start Date2022-04-26
Study Completion Date2026-01-14

Terms related to this study

Additional Relevant MeSH Terms

  • Peritoneal Carcinomatosis