Status:
COMPLETED
Heated Chemotherapy for Cancers That Have Spread to the Chest Cavity
Lead Sponsor:
St. Luke's-Roosevelt Hospital Center
Conditions:
Pleural Metastases
Breast Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 o...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01163552
Start Date
June 1 2010
End Date
May 1 2014
Last Update
June 13 2014
Active Locations (1)
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1
St. Luke's-Roosevelt Hospital Center
New York, New York, United States, 10019