deltatrials
Terminated PHASE2 INTERVENTIONAL 1-arm NCT00165503

Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate

A Phase II Feasibility Study of Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate Followed ny Adjuvant ALIMTA/Cisplatin

Sponsor: Brigham and Women's Hospital

Updated 7 times since 2017 Last updated: Jul 25, 2016 Started: Apr 30, 2004 Primary completion: Jul 31, 2010 Completion: Jul 31, 2010
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

lack of acurral

Listed as NCT00165503, this PHASE2 trial focuses on Malignant Pleural Mesothelioma and Pleural Mesothelioma and remains terminated or withdrawn. Sponsored by Brigham and Women's Hospital, it has been updated 7 times since 2004, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Study Description(click to expand)

OBJECTIVES: Primary * To determine the feasibility of administering adjuvant cisplatin plus Alimta to patients undergoing surgery with hyperthermic cisplatin. Secondary * To determine the morbidity and mortality of this treatment protocol * To determine time to tumor recurrence and patient survival * To evaluate the pharmacokinetics of intraoperatively administered cisplatin DETAILS: * Patients will undergo surgery, which is part of the standard care for mesothelioma, by a procedure called pleurectomy/decortication. This involves removal of the lining of the lung and all visible disease. Resection of the lining of the heart and the muscle that separates the chest and abdomen is occasionally necessary. * Mesothelioma samples will be taken during the surgery. These samples will be used in a laboratory study to better understand the genetic makeup of the mesothelioma and to improve our ability to diagnose this disease. * After the conclusion of the surgery, if a patient has less than 1cm thickness of residual gross disease in one or more areas, then the patient will continue on this study. If more than this volume of tumor is present, then the patient will receive additional treatment off-study. * Heated chemotherapy (cisplatin) will be given in the operating room immediately...

OBJECTIVES:

Primary

* To determine the feasibility of administering adjuvant cisplatin plus Alimta to patients undergoing surgery with hyperthermic cisplatin.

Secondary

* To determine the morbidity and mortality of this treatment protocol * To determine time to tumor recurrence and patient survival * To evaluate the pharmacokinetics of intraoperatively administered cisplatin

DETAILS:

* Patients will undergo surgery, which is part of the standard care for mesothelioma, by a procedure called pleurectomy/decortication. This involves removal of the lining of the lung and all visible disease. Resection of the lining of the heart and the muscle that separates the chest and abdomen is occasionally necessary. * Mesothelioma samples will be taken during the surgery. These samples will be used in a laboratory study to better understand the genetic makeup of the mesothelioma and to improve our ability to diagnose this disease. * After the conclusion of the surgery, if a patient has less than 1cm thickness of residual gross disease in one or more areas, then the patient will continue on this study. If more than this volume of tumor is present, then the patient will receive additional treatment off-study. * Heated chemotherapy (cisplatin) will be given in the operating room immediately following surgery. This treatment consists of a one-hour lavage of the chest and abdominal cavity with heated cisplatin through the surgical incision. At the completion of the hour, sodium thiosulfate is given intravenously for 6 hours to reduce potential side effects. * During the surgery and for four hours following the completion of the cisplatin lavage, blood samples, urine samples, chest wall muscle samples, and samples of the chemotherapy solution will be taken in order to measure the concentration of chemotherapy and the impact of cisplatin in these samples. * Patients will remain in the hospital until they have recovered from surgery (7-14 days). In addition to standard post-operative care, blood tests will be done on a daily basis. Following discharge from the hospital, patients will be seen 1-2 weeks post-operatively for additional blood work. An echocardiogram will be done 6 weeks and 6 months post-operatively to assess heart function. * Chemotherapy treatment consists of ALIMTA plus cisplatin on Day 1 of every 21-day chemotherapy cycle. A total of 3 cycles will be given starting 6-10 weeks after surgery. * Folic acid, vitamin B12 and dexamethasone will be given in addition to the chemotherapy to help reduce side effects of the chemotherapy drugs. * Approximately 30 days after the last dose of ALIMTA plus cisplatin, a CT scan(s) and blood work will be performed. In addition, patients will get a CT scan(s) every 3 months for approximately 24 months from the completion of study treatment. * Long term follow-up will consist of clinic visits every 3 months for 2 years, every 6 months for 2 years, and then once a year.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotTerminated~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotTerminated~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 19 months · monthly snapshotTerminated

Change History

7 versions recorded
  1. Sep 2024 — Present [monthly]

    Terminated PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2

  3. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE2

  4. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE2

  5. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE2

Show 2 earlier versions
  1. Feb 2017 — Jun 2018 [monthly]

    Terminated PHASE2

  2. Jan 2017 — Feb 2017 [monthly]

    Terminated PHASE2

    First recorded

Apr 2004

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute
Data source: Dana-Farber Cancer Institute

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations