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:
Beijing Cancer Hospital
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
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | July 14, 2011 | ||||||||
| Last Updated Date | January 10, 2012 | ||||||||
| Start Date ICMJE | July 2011 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
||||||||
| Original Primary Outcome Measures ICMJE |
response to chemotherapy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] | ||||||||
| Change History | Complete list of historical versions of study NCT01395056 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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). |
||||||||
| Original Secondary Outcome Measures ICMJE |
|
||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study of Chemotherapy With Adoptive Cellular Therapy With DC-CIK Cells in Triple Negative Breast Cancer Patients | ||||||||
| Official Title ICMJE | Study of Chemotherapy Combined With Adoptive Cellular Therapy With Dendritic and Cytokine-induced Killer Cells in Triple Negative Breast Cancer Patients | ||||||||
| Brief Summary | 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 |
||||||||
| Detailed Description |
|
||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: None Retained Description: about 4ml peripheral vein blood,paraffin section on metastatic tissue, |
||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | female patients with metastatic breast cancer |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||
| Estimated Completion Date | December 2014 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Female | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | China | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01395056 | ||||||||
| Other Study ID Numbers ICMJE | CTX+TSPA+CBP | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Jun Ren, Beijing Cancer Hospital | ||||||||
| Study Sponsor ICMJE | Beijing Cancer Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Beijing Cancer Hospital | ||||||||
| Verification Date | January 2012 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||