Clinical trial NCT00859495: Trimodal Lung-Sparing Treatment of Pleural Mesothelioma
Official title: Phase II, A Study of Lung-Sparing Combined Modality Protocol for the Treatment for Malignant Pleural Mesothelioma: The Columbia Protocol
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pleural Mesothelioma
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2009-03-11
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Exclusion Criteria:

* If any of the inclusion criteria was not met.

Primary outcomes:
measure: Number of Subjects Who Were Able to Complete Trimodal Therapy (Combination of Surgery, Intrapleural and Systemic Chemotherapy and P-32 Radiotherapy).
timeFrame: 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Robert N Taub, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: