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

Breast Neoplasms Clinical Trial

— DC-CIK  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01232062
• Other study ID #: HD+DC-CIK
• Status: Completed
• Phase: N/A
• First received: October 29, 2010
• Last updated: July 22, 2015
• Start date: August 2010
• Est. completion date: October 2013

Study information

• Verified date: July 2015
• Source: Beijing Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 2013
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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;

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoplasm Metastasis
• Neoplasms
• Triple Negative Breast Neoplasms

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response to chemotherapy	Response to chemotherapy is evaluated by Response Evaluation Criteria in Solid Tumors(RESIST).	4months	Yes
Secondary	Time to disease progression	Time to disease progression is measured from the date therapy is initiated to the date of documented disease progression.	six months to one year	Yes
Secondary	survival rates		one-year	Yes
Secondary	clinical benefit response	clinical benefit response include CR,PR,SD	six months to one year	Yes