Heated Chemotherapy for Cancers That Have Spread to the Chest Cavity

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01163552
• Other study ID #: SLR IRB#09-207
• Status: Completed
• Phase: Phase 2
• First received: July 14, 2010
• Last updated: June 12, 2014
• Start date: June 2010
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma, Renal Cell
• Colon Cancer
• Ovarian Cancer
• Pleural Metastases
• Pleural Neoplasms
• Renal Cell Cancer
• Thymic Cancer
• Uterine Cancer
• Uterine Neoplasms

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	St. Luke's-Roosevelt Hospital Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

Iyoda A, Yusa T, Hiroshima K, Fujisawa T. Surgical resection combined with intrathoracic hyperthermic perfusion for thymic carcinoma with an intrathoracic disseminated lesion: a case report. Anticancer Res. 1999 Jan-Feb;19(1B):699-702. — View Citation

Matsuzaki Y, Shibata K, Yoshioka M, Inoue M, Sekiya R, Onitsuka T, Iwamoto I, Koga Y. Intrapleural perfusion hyperthermo-chemotherapy for malignant pleural dissemination and effusion. Ann Thorac Surg. 1995 Jan;59(1):127-31. — View Citation

Ratto GB, Civalleri D, Esposito M, Spessa E, Alloisio A, De Cian F, Vannozzi MO. Pleural space perfusion with cisplatin in the multimodality treatment of malignant mesothelioma: a feasibility and pharmacokinetic study. J Thorac Cardiovasc Surg. 1999 Apr;117(4):759-65. — View Citation

Refaely Y, Simansky DA, Paley M, Gottfried M, Yellin A. Resection and perfusion thermochemotherapy: a new approach for the treatment of thymic malignancies with pleural spread. Ann Thorac Surg. 2001 Aug;72(2):366-70. — View Citation

Yellin A, Simansky DA, Paley M, Refaely Y. Hyperthermic pleural perfusion with cisplatin: early clinical experience. Cancer. 2001 Oct 15;92(8):2197-203. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to disease progression	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.	1 year	No
Primary	Survival	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 overall survival period following treatment with this experimental modality.	1 year	No
Secondary	Systemic drug absorption	By perfusing the chest cavity with chemotherapy, higher doses can be safely administered as less drug is absorbed systemically and therefore toxicity should be lower. This end point will assess drug toxicity due to intrathoracic perfusion.	1 month	Yes
Secondary	Complications	Patients will undergo surgical debulking prior to intrathoracic chemotherapy perfusion. Complications from the surgery as well as inhibited wound healing from chemotherapy will be monitored as a secondary end point.	1 month	Yes