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

This study is currently recruiting participants.
Verified November 2010 by Beijing Cancer Hospital
Sponsor:
Information provided by:
Beijing Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01256801
First received: December 1, 2010
Last updated: December 8, 2010
Last verified: November 2010
History of Changes
  Purpose

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 Intervention Phase
Breast Neoplasms
Neoplasm Metastasis
Gene Expression Profiling
Immunotherapy
 Biological: cytokine
 Phase 3

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beijing Cancer Hospital:

Primary Outcome Measures:
  • immunotherapy response [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Response of malignant pleural effusion to immunotherapy is evaluated with WHO guidelines


Secondary Outcome Measures:
  • immunological status [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    compare the immunological status of pleural effusion before and after the therapy


Biospecimen Retention:   Samples Without DNA

The cancer cells are taken from the malignant pleural effusion of breast cancer patiets.


Estimated Enrollment: 40
Study Start Date: November 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
cytokine
The patients are randomized to receive the cytokine infusion in the pleural cavity
 Biological: cytokine
interleukin 2 2 million unit every week
Other Name: interleukin 2 2 million unit every week

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The breast cancer patiets present with pleural effusion and can receive chemotherapy.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256801

Contacts
Contact: JUN REN, MD +86-10-88196356 renjun9688@yahoo.com
Contact: BIN SHAO, MD +86-10-88196380 xinxuange87911@yahoo.com

Locations
China
Beijing Cancer Hospital Recruiting
Beijing, China, 100142
Contact: JUN REN, MD and PhD     +86-10-88196356     renjun9688@yahoo.com    
Sponsors and Collaborators
Beijing Cancer Hospital
Investigators
Study Chair: JUN REN, MD Beijing Cancer Hospital
  More Information

No publications provided

Responsible Party: Jun Ren/Director of the Medical Oncology Department, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT01256801     History of Changes
Other Study ID Numbers: GMPE
Study First Received: December 1, 2010
Last Updated: December 8, 2010
Health Authority: China: Ministry of Health

Keywords provided by Beijing Cancer Hospital:
Metastatic Breast Neoplasms
Gene Expression Profiling
immunotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasm Metastasis
Pleural Effusion
Pleural Effusion, Malignant
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
 Respiratory Tract Neoplasms
Thoracic Neoplasms
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013