Phase 1 Mesothelioma Trial, Recruiting NCT04847063 Sponsor: National Cancer Institute (NCI) Condition: Mesothelioma
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Phase 1 Mesothelioma Trial, Recruiting

NCT04847063
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with cancer that has spread to the lining of the abdomen (called peritoneal carcinomatosis), coming from mesothelioma, an unusual cell growth in the abdomen lining, or from appendix, colon/rectal, or ovarian cancer — confirmed by the NCI's pathology lab.
  • Your cancer can be measured or tracked using standard imaging tools or a scoring system that assesses how far the cancer has spread inside the abdomen.
  • A surgeon has assessed that your cancer can be largely or completely removed surgically, and the spread of cancer inside your abdomen falls below a certain level on a scoring scale (for appendix, colon/rectal, or ovarian cancer: score below 20 out of 39; for mesothelioma or related conditions: score 30 or below out of 39).
  • You are 18 years of age or older.
  • You are in good general health and able to carry out normal daily activities with little or no difficulty.
  • Your blood, liver, and kidney function meet certain minimum health levels as measured by blood tests (confirm with trial site for exact values).
  • If you are able to become pregnant or able to father a child, you must agree to use reliable contraception (such as hormonal methods, barrier methods, or abstinence) from before the study starts until 180 days after the last treatment.
  • You are able to understand the study information and are willing to sign a consent form agreeing to take part.
  • You are willing to also join a separate tissue collection study run by the same institution.

Who may not be able to join:

  • Your cancer has spread to parts of the body outside the abdomen.
  • You have received chemotherapy directly into the abdomen or other cancer treatments within the last 4 weeks before the study starts.
  • You have had major surgery within the last 12 weeks before the study starts.
  • You have had an allergic reaction to platinum-based chemotherapy drugs in the past.
  • You have a condition called dihydropyrimidine dehydrogenase (DPD) deficiency, which affects how certain chemotherapy drugs are processed — this applies only if you have appendix or colon/rectal cancer (confirm with trial site).
  • You have a serious uncontrolled illness, such as an active infection, uncontrolled heart failure, unstable chest pain, irregular heart rhythm, or a mental health or personal situation that would make it difficult to follow the study requirements.
  • You are currently pregnant, as the study involves major abdominal surgery and chemotherapy drugs that could be harmful to an unborn baby; if you are breastfeeding, you would need to stop breastfeeding during treatment.
  • You are HIV-positive with a detectable level of the virus in your blood despite taking HIV medications; if you are HIV-positive but your virus is undetectable on treatment, you may still be considered, but only after a specialist consultation (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Andrew M Blakely, M.D., National Cancer Institute (NCI)

Phone: (240) 858-7573

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
19 October 2021
Est. completion
30 December 2033

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

To determine the correlation between ex vivo simulated HIPEC in the SMART System or 3-D cell culture (organoid) models, and in vivo HIPEC with respect to two measures of response to treatment: percent necrosis and Ki-67

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov