Know Cancer

forgot password

Phase II, A Study of Lung-Sparing Combined Modality Protocol for the Treatment for Malignant Pleural Mesothelioma: The Columbia Protocol

Phase 2
18 Years
75 Years
Open (Enrolling)
Pleural Mesothelioma

Thank you

Trial Information

Phase II, A Study of Lung-Sparing Combined Modality Protocol for the Treatment for Malignant Pleural Mesothelioma: The Columbia Protocol

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.

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the feasibility of multimodal lung sparing regimen

Outcome Description:

Intrapleural chemotherapy (12 weeks) will be administered within two weeks after surgery. Approximately 30 days post last dose of chemotherapy (+/- 14 days), the patient should be reassessed for resolution of any treatment-related toxicity which may have occurred during the course of study participation.

Outcome Time Frame:

20 weeks

Safety Issue:


Principal Investigator

Robert N Taub, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University


United States: Institutional Review Board

Study ID:

AAAB9658 (A6)



Start Date:

February 2008

Completion Date:

December 2014

Related Keywords:

  • Pleural Mesothelioma
  • Mesothelioma



Columbia University Medical CenterNew York, New York  10032