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Trimodal Lung-Sparing Treatment of Pleural Mesothelioma

Primary Purpose

Pleural Mesothelioma

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Doxorubicin

Cisplatin

Pemetrexed

Radiotherapy

About this trial

This is an interventional treatment trial for Pleural Mesothelioma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Columbia University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Multimodal lung sparing regimen

Arm Description

Intrapleural chemotherapy plus systemic chemotherapy: Thoracoscopy to implant two intrapleural catheters followed by intrapleural chemotherapy with doxorubicin and cisplatin (weeks 1, 2, 4, 5, 7, and 8). Systemic chemotherapy treatments with cisplatin and pemetrexed during weeks 3, 6, and 9. Intrapleural radiotherapy with P-32 will be given 3 weeks after last dose of chemotherapy and 11 to 12 weeks after initial thoracoscopy.

Outcomes

Primary Outcome Measures

Number of Subjects Who Were Able to Complete Trimodal Therapy (Combination of Surgery, Intrapleural and Systemic Chemotherapy and P-32 Radiotherapy).

To determine the feasibility of multimodal lung sparing regimen. 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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00859495

First Posted

March 9, 2009

Last Updated

August 12, 2020

Sponsor

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT00859495

Brief Title

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

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Terminated

Study Start Date

February 2008 (Actual)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Columbia University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pleural Mesothelioma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Multimodal lung sparing regimen

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Doxorubicin

Other Intervention Name(s)

Doxil

Intervention Description

A medication used in cancer chemotherapy, derived by chemical semisynthesis from a bacterial species.

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

Cisplatinum, Platinol

Intervention Description

Platinum-based antineoplastic

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Other Intervention Name(s)

Alimta

Intervention Description

Folate Analog Metabolic Inhibitor

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Other Intervention Name(s)

Intrapleural radiotherapy with P-32

Intervention Description

Standard procedure given 3 weeks after last dose of chemotherapy

Primary Outcome Measure Information:

Title

Number of Subjects Who Were Able to Complete Trimodal Therapy (Combination of Surgery, Intrapleural and Systemic Chemotherapy and P-32 Radiotherapy).

Description

Time Frame

20 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert N Taub, MD, PhD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Trimodal Lung-Sparing Treatment of Pleural Mesothelioma

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