Heated Intraperitonial Chemotherapy for Cancer, Appendiceal

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
National Institutes of Health Clinical Center, Bethesda, MD
Cancer, Appendiceal+10 More
Heated Intraperitonial Chemotherapy - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Individualized Response Assessment to Heated Intraperitoneal Chemotherapy (HIPEC) for the Treatment of Peritoneal Carcinomatosis From Ovarian, Colorectal, Appendiceal, or Peritoneal Mesothelioma Histologies

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Eligible Conditions

  • Cancer, Appendiceal
  • Peritoneal Carcinomatosis
  • Ovarian Cancer
  • Gastrointestinal Cancers
  • Peritoneal Mesotheliomas

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Heated Intraperitonial Chemotherapy will improve 1 primary outcome and 5 secondary outcomes in patients with Cancer, Appendiceal. Measurement will happen over the course of approx. 4 days post-HIPEC.

approx. 4 days post-HIPEC
To determine the correlation between ex vivo simulated HIPEC in the SMART System and in vivo HIPEC with respect to two measures of response to treatment: percent necrosis and Ki-67, separately within each cohort and arm subset, as well as within...
To determine the correlation between ex vivo simulated HIPEC in the SMART system and in vivo HIPEC with respect to two measures of response to treatment: percent necrosis and Ki-67
Year 5
To estimate the peritoneal progression-free survival probability as a function of tissue response to ex vivo simulated HIPEC in the SMART System and in vivo HIPEC, as assessed by percent necrosis and Ki-67, in a preliminary fashion
To estimate the peritoneal progression-free survival probability, separately by arms and by cohorts, in a preliminary fashion
To measure Quality of Life by FACT-C and EQ-5D-5L
Year 5
To evaluate overall survival for up to 5 years after CRS and HIPEC

Trial Safety

Trial Design

4 Treatment Groups

3/ HIPEC: Cisplatin, Doxorubicin Randomized treatment assignme
1 of 4
4/ HIPEC: Cisplatin, Mitomycin C Randomized treatment assignme
1 of 4
1/ HIPEC: Oxaliplatin Randomized treatment assignment
1 of 4
2/ HIPEC: Mitomycin C Randomized treatment assignment
1 of 4
Experimental Treatment

This trial requires 60 total participants across 4 different treatment groups

This trial involves 4 different treatments. Heated Intraperitonial Chemotherapy is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

3/ HIPEC: Cisplatin, Doxorubicin Randomized treatment assignmeHIPEC with intraperitoneal cisplatin and doxorubicin, in addition to IV sodium thiosulfate, randomly assigned
4/ HIPEC: Cisplatin, Mitomycin C Randomized treatment assignmeHIPEC with intraperitoneal cisplatin and mitomycin C, in addition to IV sodium thiosulfate, randomly assigned
1/ HIPEC: Oxaliplatin Randomized treatment assignmentHIPEC with intraperitoneal oxaliplatin and IV 5-FU, randomly assigned
2/ HIPEC: Mitomycin C Randomized treatment assignmentHIPEC with intraperitoneal mitomycin C, randomly assigned
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxaliplatin
FDA approved
Doxorubicin
FDA approved
Cisplatin
FDA approved
Thiosulfuric acid
FDA approved
Mitomycin
FDA approved
Fluorouracil
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: death or 5 years post-treatment
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly death or 5 years post-treatment for reporting.

Closest Location

National Institutes of Health Clinical Center - Bethesda, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Confirmation of peritoneal carcinomatosis from appendiceal, colorectal, ovarian, or peritoneal mesothelioma histologies by the Laboratory of Pathology, NCI.
Participants must be assessed to be able to undergo complete cytoreduction, with PCI score <= 30 at the time of laparoscopy.
Age >= 18 years.
Absolute neutrophil count >= 1,000/mcL
Platelets >= 75,000/mcL
Total bilirubin within normal institutional limits
AST (SGOT)/ ALT (SGPT) <= 3x institutional upper limit of normal (ULN)
Measurable or evaluable disease as defined by RECIST v1.1. show original
You have a performance status of 1 (Karnofsky >80%). show original
The leukocyte count is greater than 3,000/mcL. show original

Patient Q&A Section

What are common treatments for mesothelioma?

"Mesothelioma is an incurable disease. Treatment is largely surgical and relies on the overall efficacy of chemotherapy, radiation, and palliative care. There are many different types of surgery, many different types of chemotherapy, and many options of palliative care available to those with mesothelioma. There are new possibilities of the use of immunotherapies and targeted therapies. It is an important tool in therapy when using chemotherapy, radiation therapy, and surgery. There is a very long survival rate for those with early stage tumors if they are treated properly with timely surgery, chemotherapy, and radiation therapy. Patients are advised to look for a referral to a lung cancer expert and consider the treatment options for their specific case." - Anonymous Online Contributor

Unverified Answer

What are the signs of mesothelioma?

"Palpable mass may be a late sign of mesothelioma. Patients with known asbestos exposure are at particular risk for developing mesothelioma and thus careful consideration may be warranted in the evaluation of patients with no prior exposure." - Anonymous Online Contributor

Unverified Answer

What causes mesothelioma?

"This condition is often due to asbestos exposure. Asbestos fibers may be passed with the air by inhalation or the pleural surfaces of the lungs. The fiber may be inhaled as very fine particles or may become lodged in the alveoli. Asbestos fibers are deposited in the pleura, pleural membranes, and peritoneum of the lungs but are rarely present in normal tissues. The mechanism through which asbestos fibers cause cancer is not thoroughly understood. However, it has become apparent by epidemiological studies that the majority of cases of mesothelioma occur in people exposed to asbestos during their lives. It is therefore apparent that an asbestos-related condition is a risk factor for the development of these malignancies." - Anonymous Online Contributor

Unverified Answer

What is mesothelioma?

"Mesothelioma is a deadly but rare malignancy of the peritoneum and pleural surfaces that commonly involves pericardium, pleura and peri-aortico visceral pleura. Symptoms may include weight loss and shortness of breath. In some patients with mesothelioma, peritoneal metastases may occur, and long-term survival is poor. There are several treatment options with varying success rates. The most successful treatment of mesothelioma is radical excision of all masses involved during surgery. Radiation therapy has been found in a small percentage of patients to be an effective adjunct treatment." - Anonymous Online Contributor

Unverified Answer

Can mesothelioma be cured?

"A cure is not available in this disorder. Treatment is best directed at improving symptom control, and supportive care is provided to minimize complications of the disease." - Anonymous Online Contributor

Unverified Answer

How many people get mesothelioma a year in the United States?

"MES is an important cause of death for people in the United States. Each year, around 7,200 people are diagnosed with this disease, making it the ninth-most common cancer in American citizens. The numbers are projected to rise greatly over the next few decades as a consequence of occupational exposure to asbestos." - Anonymous Online Contributor

Unverified Answer

Does mesothelioma run in families?

"Genetic loci for mesothelioma susceptibility have been identified (see Genetics of mesothelioma). Most studies have assessed associations between mesothelioma and inheritance patterns based on families with a history of the disease (family history), a member of the same generation (sibling or child), or members of the same first degree relative (parents or grandparents) diagnosed with the disease. Of all these studies, only those using siblings have found an increase in mesothelioma risk in relatives. Many of these studies have shown that individuals and families who are of a certain ethnic background, such as Caucasians (Caucasoid), have a far higher risk of developing mesothelioma." - Anonymous Online Contributor

Unverified Answer

Is heated intraperitonial chemotherapy typically used in combination with any other treatments?

"HIC is often included with chemotherapy and radiotherapy. However, our study shows that it has limited use, often used alone in some centers. In addition, there has not been enough data regarding HIC in combination with radiotherapy. There is an ongoing study exploring the use of HIC in combination with radiotherapy in patients with mesothelioma." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating mesothelioma?

"New treatments appear to offer promise for patients with this devastating disease. One of the new strategies seems to use cytokines and immune system activating agents as well as chemotherapeutics. Combination therapy involving vinorelbine and chemotherapy with paclitaxel may be a useful treatment. A phase II trial is currently in progress using vinorelbine combined with cisplatin, cisplatin, cyclophosphamide, and dexamethasone (PACD or “PEACE” chemotherapy), and with a second drug, cisplatin plus paclitaxel (PAC + cisplatin) as two separate drugs." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of heated intraperitonial chemotherapy?

"The common side effects of HIPEC include fever, nausea, vomiting and myelosuppression (loss of the bone marrow and lymphocytes (the body's defenses against infection)). Nausea and vomiting were often severe enough that patients required hospitalization for treatment." - Anonymous Online Contributor

Unverified Answer

How does heated intraperitonial chemotherapy work?

"HCPT (Heated Intraperitonial Chemotherapy) was found to be effective and safe for treating peritoneal mesothelioma. We have proved that HCPT will be effective and safe against peritoneal mesothelioma." - Anonymous Online Contributor

Unverified Answer

Is heated intraperitonial chemotherapy safe for people?

"There is no evidence to indicate i) that HIPEC is safe but may cause an increase of fever, ii) that HIPEC has any adverse effects on survival, and iii) routine testing of the liver may be useful to detect metastatic tumors. We suggest that HIPEC should not be used for patients who present with advanced stage disease." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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