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Study of Chemotherapy With Adoptive Cellular Therapy With DC-CIK Cells in Triple Negative Breast Cancer Patients (DCCIK)

This study is currently recruiting participants.
Verified January 2012 by Beijing Cancer Hospital
Sponsor:
Information provided by (Responsible Party):
Jun Ren, Beijing Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01395056
First received: July 14, 2011
Last updated: January 10, 2012
Last verified: January 2012
History of Changes
  Purpose

To access the effectiveness of cyclophosphamide combined thiotepa and carboplatin chemotherapy combined with adoptive cellular therapy with dendritic and cytokine-induced killer cells in triple negative metastatic breast cancer patients


Condition
Breast Neoplasms
Neoplasm Metastasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Chemotherapy Combined With Adoptive Cellular Therapy With Dendritic and Cytokine-induced Killer Cells in Triple Negative Breast Cancer Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beijing Cancer Hospital:

Primary Outcome Measures:
  • progression-free survival [ Time Frame: six months to two year ] [ Designated as safety issue: Yes ]
    progression-free survivalis measured from the date therapy is initiated to the date of documented disease progression or death


Secondary Outcome Measures:
  • clinical benefit response and overall survival [ Time Frame: six months to two year ] [ Designated as safety issue: Yes ]
    clinical benefit response include complete release(CR), partial release (PR), stable disease (SD).


Biospecimen Retention:   None Retained

about 4ml peripheral vein blood，paraffin section on metastatic tissue，


Estimated Enrollment: 50
Study Start Date: July 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed Description:
  1. Metastatic breast cancer patients should be definitively diagnosis based on histopathology, with ER-negative and PR-negative, FISH testing for her-2-negative
  2. All the patients enrolled will be given standard cyclophosphamide combined thiotepa and carboplatin chemotherapy and cellular therapy.Cellular therapy consisting of one cycle of chemotherapy followed by an apheresis and ex vivo cultures to generate DC and CIK, followed by low-dose Oral Cyclophosphamide .
  3. The response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines.
  4. Estimate time to progression, survival rates and clinical benefit response on patients.
  5. Find biomarkers associated with drug response.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

female patients with metastatic breast cancer

Criteria

Inclusion Criteria:

  • Failure to anthracycline and/or taxol chemotherapy;
  • metastatic tumor is histologically confirmed by immunohistochemical staining to be ER-negative and PR-negative. FISH testing for her-2-negative;
  • Metastatic tumor can not be removed through surgery procedure;
  • An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  • Normal cardiac, hepatic, renal and bone marrow functions;
  • Life expectancy ≥3 months.

Exclusion Criteria:

  • Central nervous system metastases;
  • Serious or uncontrolled concurrent medical illness;
  • History of other malignancies;
  • Having been enrolled in some other clinal trials within a month;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01395056

Contacts
Contact: Jun Ren, MD, PhD +86-10-88196356 renjun9688@yahoo.com
Contact: Jing Yu, MD, PhD +86-10-88196380 2004yujing@163.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
Principal Investigator: Jing Yu, MD, PhD Beijing Cancer Hospital
  More Information

No publications provided

Responsible Party: Jun Ren, Director of the Medical Oncology, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT01395056     History of Changes
Other Study ID Numbers: CTX+TSPA+CBP
Study First Received: July 14, 2011
Last Updated: January 10, 2012
Health Authority: China: Ministry of Health

Keywords provided by Beijing Cancer Hospital:
breast neoplasm
Neoplasm Metastasis
Drug Therapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasm Metastasis
Neoplasms by Site
 Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013