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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01256801
Other study ID # GMPE
Secondary ID
Status Completed
Phase Phase 3
First received December 1, 2010
Last updated July 27, 2015
Start date November 2010
Est. completion date December 2013

Study information

Verified date July 2015
Source Beijing Cancer Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date December 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Biological:
cytokine
interleukin 2 2 million unit every week

Locations

Country Name City State
China Beijing Cancer Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary immunotherapy response Response of malignant pleural effusion to immunotherapy is evaluated with WHO guidelines 1 month Yes
Secondary immunological status compare the immunological status of pleural effusion before and after the therapy 1 month Yes
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