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Surgical Cytoreduction Followed by Intraoperative Intrathoracic Hyperthermic Chemotherapy Perfusion for the Management of Disseminated Pleural Malignancies


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Pleural Metastases, Breast Cancer, Colon Cancer, Ovarian Cancer, Uterine Cancer, Renal Cell Cancer, Thymic Cancer

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Trial Information

Surgical Cytoreduction Followed by Intraoperative Intrathoracic Hyperthermic Chemotherapy Perfusion for the Management of Disseminated Pleural Malignancies


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to disease progression

Outcome Description:

Most cancers that have spread to the chest cavity have limited survival. Response to systemic chemotherapy and radiation therapy is short-lived. This end point will determine the time to disease progression of this experimental treatment modality.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Cliff P Connery, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Luke's-Roosevelt Hospital Center, Division of Thoracic Surgery

Authority:

United States: Institutional Review Board

Study ID:

SLR IRB#09-207

NCT ID:

NCT01163552

Start Date:

June 2010

Completion Date:

June 2013

Related Keywords:

  • Pleural Metastases
  • Breast Cancer
  • Colon Cancer
  • Ovarian Cancer
  • Uterine Cancer
  • Renal Cell Cancer
  • Thymic Cancer
  • pleural metastases
  • Breast Neoplasms
  • Colonic Neoplasms
  • Carcinoma, Renal Cell
  • Neoplasm Metastasis
  • Ovarian Neoplasms
  • Thymus Neoplasms
  • Uterine Neoplasms
  • Pleural Neoplasms

Name

Location

St. Luke's-Roosevelt Hospital CenterNew York, New York