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

July 14, 2011
January 10, 2012
July 2011
December 2013   (final data collection date for primary outcome measure)
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
response to chemotherapy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01395056 on ClinicalTrials.gov Archive Site
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).
  • Time to disease progression [ Time Frame: six months to one year ] [ Designated as safety issue: Yes ]
    Time to disease progression is measured from the date therapy is initiated to the date of documented disease progression
  • clinical benefit response [ Time Frame: six months to one year ] [ Designated as safety issue: Yes ]
    clinical benefit response include CR,PR,SD
Not Provided
Not Provided
 
Study of Chemotherapy With Adoptive Cellular Therapy With DC-CIK Cells in Triple Negative Breast Cancer Patients
Study of Chemotherapy Combined With Adoptive Cellular Therapy With Dendritic and Cytokine-induced Killer Cells in Triple Negative Breast Cancer Patients

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

  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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:

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

Non-Probability Sample

female patients with metastatic breast cancer

  • Breast Neoplasms
  • Neoplasm Metastasis
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2014
December 2013   (final data collection date for primary outcome measure)

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;
Female
18 Years to 80 Years
No
Contact: Jun Ren, MD, PhD +86-10-88196356 renjun9688@yahoo.com
Contact: Jing Yu, MD, PhD +86-10-88196380 2004yujing@163.com
China
 
NCT01395056
CTX+TSPA+CBP
Yes
Jun Ren, Beijing Cancer Hospital
Beijing Cancer Hospital
Not Provided
Principal Investigator: Jing Yu, MD, PhD Beijing Cancer Hospital
Beijing Cancer Hospital
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP