Study of High-dose Chemotherapy (HDC) Combined With Adoptive Cellular Therapy With DC-CIK Cells in Triple Negative Breast Cancer Patients

This study is currently recruiting participants.
Verified August 2010 by Beijing Cancer Hospital
Sponsor:
Information provided by:
Beijing Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01232062
First received: October 29, 2010
Last updated: August 17, 2011
Last verified: August 2010
  Purpose

To access the effectiveness of High-dose Cyclophosphamide Combined Chemotherapy combined with adoptive cellular therapy with dentritic 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: Retrospective
Official Title: Study of High-dose Chemotherapy Combined With Adoptive Cellular Therapy With Dentritic and Cytokine-induced Killer Cells in Triple Negative Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Beijing Cancer Hospital:

Primary Outcome Measures:
  • response to chemotherapy [ Time Frame: 4months ] [ Designated as safety issue: Yes ]
    Response to chemotherapy is evaluated by Response Evaluation Criteria in Solid Tumors(RESIST).


Secondary Outcome Measures:
  • 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.

  • survival rates [ Time Frame: one-year ] [ Designated as safety issue: Yes ]
  • clinical benefit response [ Time Frame: six months to one year ] [ Designated as safety issue: Yes ]
    clinical benefit response include CR,PR,SD


Biospecimen Retention:   None Retained

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


Estimated Enrollment: 50
Study Start Date: August 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 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 HDC and cellular therapy.HDC and cellular therapy consisting of one cycle of HDC followed by an apheresis and ex vivo cultures to generate DC and CIK. DC-CIK infusions were given to each patient, followed by two cycles HDC, plus low-dose Oral Cyclophosphamide.
  3. PET-CT scans were done on each patients at baseline and after chemotherapy. 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 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   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;
  • Metastatic tumor measured by PET-CT scan is at least 1cm;
  • 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:

  • Do not finish twice PET-CT scan;
  • 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: NCT01232062

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
Principal Investigator: CHAO YING WANG, MD, PhD Beijing Cancer Hospital
Study Chair: JUN REN, MD, PhD Beijing Cancer Hospital
Principal Investigator: YU LIN ZHU, MD, PhD Bei jing Cancer Hospital
Principal Investigator: Jie Zhang, 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: NCT01232062     History of Changes
Other Study ID Numbers: HD+DC-CIK
Study First Received: October 29, 2010
Last Updated: August 17, 2011
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 April 15, 2014