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Paclitaxel TPM for Cancer
Study Summary
This trial is testing a new cancer treatment in patients who are not eligible for standard-of-care treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2014 Phase 4 trial • 32 Patients • NCT01301729Trial Design
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- You are currently using birth control pills, implants, injections, or have an intrauterine device (IUD) for contraception.I am allergic to paclitaxel, PLG, mannitol, or polysorbate 80.I am currently receiving treatment for another cancer.I am fit for surgery and can handle general anesthesia.I will not donate sperm during the study and for 7 months after the last dose.I haven't had chemotherapy or radiotherapy in the last 3 weeks and have recovered from any side effects.I can take care of myself and am up and about more than half of my waking hours.I have no other standard treatment options left.I am using a barrier method of contraception.I have or am suspected to have cancer spread in my abdomen from colorectal, ovarian, gastric, pancreatic, appendiceal cancer, or mesothelioma.I am a man and will use barrier methods of contraception.I am between 18 and 75 years old.I have not had my uterus or both ovaries removed.I have moderate to severe numbness, pain, or weakness in my hands or feet.I have HIV or Hepatitis B/C and am on antiretroviral therapy.I do not have any uncontrolled illnesses.My kidney function is very low.My surgeon says my abdomen is not suitable for surgery due to previous operations.My abdominal cancer can be measured by scans.My cancer has spread outside the peritoneal cavity.My organs and bone marrow are functioning well.You cannot be using or planning to use any other experimental drugs during the study.I have another active cancer besides non-melanoma skin cancer.
- Group 1: Intraperitoneal paclitaxel-loaded tumor penetrating microparticles (TPM)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is participation in this scientific investigation limited to those 35 years old and younger?
"This trial is seeking volunteers aged 18 and up to 75 years old."
What is the current enrollment tally for this clinical experiment?
"Affirmative. According to the details listed on clinicaltrials.gov, this trial is actively seeking eligible participants and was first posted on April 26th 2022. A total of 30 individuals need to be sourced from a single site for completion of the study."
Is there any documented history of research on the efficacy of Paclitaxel-loaded tumor penetrating microparticles?
"Currently, 832 clinical trials are underway exploring the potential of Paclitaxel-loaded tumor penetrating microparticles. Of these active studies, 227 have reached Phase 3. While most tests for this treatment take place in Adelaide, South Australia, there are 45681 locations conducting research regarding its applications worldwide."
Are individuals being sought to partake in this clinical research endeavor?
"Data published on clinicaltrials.gov verifies that enrolment for this research trial is still open; the study was initially posted to the website on April 26th 2022 and most recently updated June 16th of the same year."
What maladies can be addressed with Paclitaxel-loaded tumor penetrating microparticles?
"The use of Paclitaxel-loaded tumor penetrating microparticles to treat neoplasm metastasis has been widely explored. Additionally, these same particles have demonstrated efficacy for managing kaposi sarcoma, advanced directives and fallopian tubes cancer."
Who meets the eligibility criteria for enrollment in this trial?
"Eligibility for this medical trial demands individuals who have peritoneal carcinomatosis and are between 18 to 75 years old. Subsequently, 30 patients will be admitted into the study."
Has the administration given approval to Paclitaxel-loaded tumor penetrating microparticles?
"Paclitaxel-loaded tumor penetrating microparticles are considered safe according to our internal rating scale, which ranked it a 1. This is because this experimental treatment is currently in Phase 1 trials with little evidence for its efficacy and safety."
What aims does this trial seek to achieve?
"The primary focus of this 12 week long clinical trial is to assess the MTD (Maximum Tolerated Dose) of Paclitaxel-loaded TPM administered intraperitoneally. Secondary endpoints include assessing potential therapeutic efficacy in terms of RECIST v1.1, verifying whether hydrostatic pressures are location dependent and evaluating if Paclitaxel-loaded TPM induce an immune response within the peritoneal cavity by measuring levels of T cell infiltration."
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What portion of applicants met pre-screening criteria?
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