Trimodal Lung-Sparing Treatment of Pleural Mesothelioma
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/2/2016 |
| Start Date: | February 2008 |
| End Date: | December 2014 |
| Contact: | Herbert Irving Comprehensive Cancer Center Clinical Research Management Office |
| Phone: | 212-305-8615 |
Phase II, A Study of Lung-Sparing Combined Modality Protocol for the Treatment for Malignant Pleural Mesothelioma: The Columbia Protocol
The primary objective of the study is to determine the feasibility (as determined by lack of
serious adverse events) and tolerability (as determined by patient's ability to complete the
study) of a multimodal lung sparing regimen of surgery, interpleural and intravenous
chemotherapy, and local P-32 irradiation for malignant pleural mesothelioma.
serious adverse events) and tolerability (as determined by patient's ability to complete the
study) of a multimodal lung sparing regimen of surgery, interpleural and intravenous
chemotherapy, and local P-32 irradiation for malignant pleural mesothelioma.
Current surgical and/or chemotherapeutic approaches for malignant pleural mesothelioma are
unsatisfactory and have not been shown to significantly prolong survival, and often lead to
worsened pulmonary function and quality of life. We will investigate whether a prospective
trial of trimodal (surgery, pleural chemotherapy, and pleural radiation) therapy can improve
the overall 1 year survival in patients with malignant pleural mesothelioma. The proposed
treatment will include exploratory thoracoscopy, placement of Mediport catheters into the
pleural space, intraoperative chemotherapy, repeated intraperitoneal chemotherapy, and
intrapleural instillation of radioactive P32 to radiate the pleural surfaces. In addition,
because this study is randomized, half the patients will receive an additional three
intravenous systemic chemotherapy treatments of cisplatin and pemetrexed (Alimta) in tandem
with their intrapleural chemotherapy (weeks 3, 6, and 9 only).
The potential significance of this research is that such treatment may render it less
necessary to surgically remove the affected lungs in whole or in part, in order to achieve
significant disease cytoreduction. We hope to alter the currently accepted paradigm that
major lung surgery is an inescapable component of such treatment, and advance the concept
that a combination of judicious preparative surgery, systemic chemotherapy, and locoregional
drug treatment of the pleural surfaces may offer the best hope for prolongation of survival
with intact lung function.
unsatisfactory and have not been shown to significantly prolong survival, and often lead to
worsened pulmonary function and quality of life. We will investigate whether a prospective
trial of trimodal (surgery, pleural chemotherapy, and pleural radiation) therapy can improve
the overall 1 year survival in patients with malignant pleural mesothelioma. The proposed
treatment will include exploratory thoracoscopy, placement of Mediport catheters into the
pleural space, intraoperative chemotherapy, repeated intraperitoneal chemotherapy, and
intrapleural instillation of radioactive P32 to radiate the pleural surfaces. In addition,
because this study is randomized, half the patients will receive an additional three
intravenous systemic chemotherapy treatments of cisplatin and pemetrexed (Alimta) in tandem
with their intrapleural chemotherapy (weeks 3, 6, and 9 only).
The potential significance of this research is that such treatment may render it less
necessary to surgically remove the affected lungs in whole or in part, in order to achieve
significant disease cytoreduction. We hope to alter the currently accepted paradigm that
major lung surgery is an inescapable component of such treatment, and advance the concept
that a combination of judicious preparative surgery, systemic chemotherapy, and locoregional
drug treatment of the pleural surfaces may offer the best hope for prolongation of survival
with intact lung function.
Inclusion Criteria:
- Histologically confirmed malignant mesothelioma, < 20% sarcomatoid type
- No radiographic or other imaging evidence of Stage IV (cardiac, mediastinal,
peritoneal, other distant) disease.
- Ineligible for other high priority national or institutional study.
- Age >18 years [to physiologic 75 years].
- Life expectancy > 3 months.
- Performance status, PS 0-2 [Karnofsky Performance Status, KPS=70-100 %].
- Prior therapy allowed (one prior systemic regimen) meeting the following parameters.
- No prior chest radiation therapy within 6 weeks of treatment
- No prior chemotherapy regimens within four weeks of treatment
- Non pregnant, non-lactating. (serum HCG test will be performed in patients in whom
there is a possibility of pregnancy.)
- Required initial laboratory data/clinical parameters (see also Sec. 8.0) White cell
count: >3000/ul. Platelet count: >100,000/ul. Creatinine clearance: ≥ 45 ml/min
Bilirubin: < 2 x ULN SGOT or SGPT: < 2 x ULN
- Informed Consent: Each patient must be completely aware of the nature of his/her
disease process and must willingly give consent after being informed of the procedure
to be followed, the experimental nature of the therapy, alternatives, potential
benefits, side-effects, risks, and discomforts.
- No other coexistent malignancy. However, curatively treated or fully controlled solid
tumors (other than mesothelioma) may be eligible if in the judgement of the PI, the
benefit of treatment outweighs the risk.
- No serious medical or psychiatric illness preventing informed consent or intensive
treatment (e.g., serious infection, congestive heart failure, angina pectoris,
cardiac arrhythmia(s), or uncontrolled hypertension). HIV status or other severe
illnesses will be assessed using medical records.
We found this trial at
1
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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