Heated Chemotherapy for Cancers That Have Spread to the Chest Cavity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2014-05-31

Brief Summary

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Cancers that have spread to the inner lining of the chest are classified as Stage IV and bear a poor prognosis. Surgery is rarely an option, with palliative chemotherapy and/or radiation therapy the only treatment options. This study intends to evaluate whether surgical removal of all visible tumor on the chest wall followed by bathing the chest cavity in heated chemotherapy solution will improve outcomes for these advanced cancers.

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Detailed Description

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Conditions

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Pleural Metastases Breast Cancer Colon Cancer Ovarian Cancer Uterine Cancer Renal Cell Cancer Thymic Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgical Debulking and Intrathoracic Hyperthermic Chemotherapy

Patients in this trial will undergo surgical debulking followed by intrathoracic hyperthermic chemotherapy perfusion.

Group Type EXPERIMENTAL

Surgical debulking and Intrathoracic Hyperthermic Chemotherapy

Intervention Type PROCEDURE

Surgical debulking of intrathoracic metastases will be performed, followed by perfusion of the chest with heated Cisplatin for 60 minutes.

Interventions

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Surgical debulking and Intrathoracic Hyperthermic Chemotherapy

Surgical debulking of intrathoracic metastases will be performed, followed by perfusion of the chest with heated Cisplatin for 60 minutes.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Adults aged 18-75 years
2. Radiographic evidence of pleural dissemination with histologically or cytologically confirmed diagnosis.
3. Primary source control (breast, ovarian, uterine, colon, renal cell, thymic cancer)
4. Adequate liver and renal function defined as a bilirubin of \< 2.0 mg/dl, albumin \> 3.0g/dl, and a creatinine of \< 1.5 mg/dl, respectively.
5. Absolute neutrophil count (ANC) of ≥1,500/mm3 and a platelet count ≥100,000/mm3.
6. A Karnofsky Performance Status score of ≥60

Exclusion Criteria

1. Patients without satisfactory oncological control of their primary cancer.
2. Radiographic evidence of abdominal, pelvic, or intracranial metastatic disease.
3. Chemotherapy and/or radiotherapy must have been completed at least one month prior to entry in the study. Patients may not receive concurrent chemotherapy, immunotherapy, radiotherapy, or any investigational drugs while participating in this study.
4. Significant active medical disease including, but not limited to:

* Cardiac disease, including: congestive heart failure or angina pectoris; recent (within 1 year) history of a myocardial infarction; uncontrolled hypertension; arrhythmias.
* Active infections
* Uncontrolled diabetes mellitus
* Chronic renal insufficiency
* HIV/AIDS - routine HIV testing will not be performed, but patients known to be HIV positive will be excluded.
5. Pregnant or lactating women.
6. Allergy to intravenous contrast

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No