Trimodal Lung-Sparing Treatment of Pleural Mesothelioma

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedDoxorubicin and Cisplatin

Plus 2 other study approaches.

Who it may be forMesothelioma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 25, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Columbia University

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Columbia University
Interventions being studied: Drug: Doxorubicin; Drug: Cisplatin; Drug: Pemetrexed; Radiation: Radiotherapy

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Mesothelioma→

Treatment approach

Chemotherapy→Radiation therapy→Surgery→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion criteria

If any of the inclusion criteria was not met.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Columbia University Medical CenterNew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 25, 2020. Always confirm current availability with the study team.

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