Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Active | 18 to 85 | Other | SLR IRB#09-207 NCT01163552 |
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.
Eligibility Criteria
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
Trial Lead Organizations/Sponsors
St. Luke's-Roosevelt Hospital Center - Roosevelt Division
| Cliff P. Connery |  | Principal Investigator |
| Cliff P Connery, MD | | Ph: 2125237475 |
| Email: cconnery@chpnet.org | ||
Trial Sites
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| U.S.A. | |||
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| New York | |||
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| New York | |||
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| St. Luke's-Roosevelt Hospital Center - Roosevelt Division | |||
| Cliff P. Connery | Principal Investigator | ||
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01163552
Information obtained from ClinicalTrials.gov on November 20, 2012
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