GMPE: Gene Expression Profiling of Breast Cancer Cells Predict the Response of Malignant Pleural Effusion

Sponsor

Peking University Cancer Hospital & Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01256801

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators want to develop a gene expression profile for the prediction of immunotherapy response of patients with metastatic breast cancer presenting malignant pleural effusion.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms Neoplasm Metastasis Gene Expression Profiling Immunotherapy	Biological: cytokine

Detailed Description

The patiets with malignant pleural effusion are randomizned to be treated with cytokins(inteleukin 2) or dendritic cells(DC) plus cytokine induced killer cells(CIK) locally.
Malignant pleural effusion from metastatic breast cancer patient is obtained through thoracentesis and is centrifugalized to enrich cancer cells before the therapy.
The enriched cancer cells are flash frozen and stored at -80℃ until processing.
The gene expression in pleural effusion is detected by microarray to screen gene markers that are differently expressed between groups .
Statistical analysis is performed using unsupervised hierarchical cluster.

Study Design

Study Type:

Observational

Actual Enrollment :

36 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Gene Expression Profiling of Breast Cancer Cells in Pleural Effusion Prodict the Response of Malignant Pleural Effusion to Immunotherapy

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
cytokine The patients are randomized to receive the cytokine infusion in the pleural cavity	Biological: cytokine interleukin 2 2 million unit every week Other Names: interleukin 2 2 million unit every week

Arm

Intervention/Treatment

cytokine

The patients are randomized to receive the cytokine infusion in the pleural cavity

Biological: cytokine

interleukin 2 2 million unit every week

Other Names:

interleukin 2 2 million unit every week

Outcome Measures

Primary Outcome Measures

immunotherapy response [1 month]
Response of malignant pleural effusion to immunotherapy is evaluated with WHO guidelines

Secondary Outcome Measures

immunological status [1 month]
compare the immunological status of pleural effusion before and after the therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients should be histologically confirmed with metastatic breast cancer and malignant pleural effusion
an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
At least one measurable lesion;
Normal cardiac, hepatic, renal and bone marrow functions;
Life expectancy ≥3 months;
Discontinuity of previous chemotherapy for a minimum of 4 weeks.
Not receive chemotherapy in pleural cavity