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

NCT ID: NCT01256801

Last Updated: 2015-07-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-12-31

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.

Detailed Description

1. 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.

2. Malignant pleural effusion from metastatic breast cancer patient is obtained through thoracentesis and is centrifugalized to enrich cancer cells before the therapy.

3. The enriched cancer cells are flash frozen and stored at -80℃ until processing.

4. The gene expression in pleural effusion is detected by microarray to screen gene markers that are differently expressed between groups .

5. Statistical analysis is performed using unsupervised hierarchical cluster.

Conditions

Breast Neoplasms; Neoplasm Metastasis; Gene Expression Profiling; Immunotherapy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

cytokine

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

cytokine

Intervention Type: BIOLOGICAL

interleukin 2 2 million unit every week

Interventions

cytokine

interleukin 2 2 million unit every week

Intervention Type: BIOLOGICAL

Other Intervention Names

interleukin 2 2 million unit every week

Eligibility Criteria

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

Exclusion Criteria

• previous history of other malignancies;
• previous surgery history on the needle biopsy organ;
• Serious or uncontrolled concurrent medical illness.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Jun Ren

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

JUN REN, MD

Role: STUDY_CHAIR

Peking University Cancer Hospital & Institute

Locations

Beijing Cancer Hospital

Beijing, , China

Countries

China

Other Identifiers

GMPE

Identifier Type: -

Identifier Source: org_study_id