NCT01163552

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 13, 2014

Status Verified

June 1, 2014

Enrollment Period

3.9 years

First QC Date

July 14, 2010

Last Update Submit

June 12, 2014

Conditions

Pleural MetastasesBreast CancerColon CancerOvarian CancerUterine CancerRenal Cell CancerThymic Cancer

Keywords

pleural metastases

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (2)

  • Systemic drug absorption

    1 month

  • Complications

    1 month

Study Arms (1)

Surgical Debulking and Intrathoracic Hyperthermic Chemotherapy

EXPERIMENTAL

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

Procedure: Surgical debulking and Intrathoracic Hyperthermic Chemotherapy

Interventions

Surgical debulking and Intrathoracic Hyperthermic ChemotherapyPROCEDURE

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

Surgical Debulking and Intrathoracic Hyperthermic Chemotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18-75 years
  • Radiographic evidence of pleural dissemination with histologically or cytologically confirmed diagnosis.
  • Primary source control (breast, ovarian, uterine, colon, renal cell, thymic cancer)
  • 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.
  • Absolute neutrophil count (ANC) of ≥1,500/mm3 and a platelet count ≥100,000/mm3.
  • A Karnofsky Performance Status score of ≥60

You may not qualify if:

  • Patients without satisfactory oncological control of their primary cancer.
  • Radiographic evidence of abdominal, pelvic, or intracranial metastatic disease.
  • 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.
  • 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.
  • Pregnant or lactating women.
  • Allergy to intravenous contrast

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Luke's-Roosevelt Hospital Center

New York, New York, 10019, United States

Location

Related Publications (5)

  • 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. doi: 10.1016/0003-4975(94)00614-D.

    PMID: 7818311BACKGROUND

  • 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. doi: 10.1016/S0022-5223(99)70297-7.

    PMID: 10096972BACKGROUND

  • Yellin A, Simansky DA, Paley M, Refaely Y. Hyperthermic pleural perfusion with cisplatin: early clinical experience. Cancer. 2001 Oct 15;92(8):2197-203. doi: 10.1002/1097-0142(20011015)92:83.0.co;2-f.

    PMID: 11596038BACKGROUND

  • 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.

    PMID: 10216479BACKGROUND

  • 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. doi: 10.1016/s0003-4975(01)02786-2.

    PMID: 11515868BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsColonic NeoplasmsOvarian NeoplasmsUterine NeoplasmsCarcinoma, Renal CellThymus Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersUterine DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeKidney NeoplasmsUrologic NeoplasmsKidney DiseasesUrologic DiseasesMale Urogenital DiseasesThoracic NeoplasmsLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Cliff P Connery, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 14, 2010

First Posted

July 15, 2010

Study Start

June 1, 2010

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

June 13, 2014

Record last verified: 2014-06

Locations

US(1)