Ignite Creation Date:
2024-05-06 @ 12:46 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01655628
Status:
UNKNOWN
Last Update Posted:
2012-08-02
First Post:
2012-07-26
Brief Title:
GC Regimen Chemotherapy Plus CIK Cells for Metastatic Nasopharyngeal Carcinoma
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Autologous Cytokine-Induced Killer Cell Transfusion in Combination With Gemcitabine Plus Cisplatin Regimen Chemotherapy for Metastatic Nasopharyngeal Carcinoma
Status:
UNKNOWN
Status Verified Date:
2012-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nasopharyngeal carcinoma NPC is one of the most common malignant tumors in Southern China and South Asia After radiotherapy some patients with nasopharyngeal carcinoma still had distant metastasis In recent years some chemotherapeutic agents such as gemcitabine cisplatin were used to treat patients with advanced nasopharyngeal carcinoma including those with local recurrence and distant metastases with a certain short-term effect However chemotherapy alone is still not ideal for effectively improving the prognosis of patients with advanced nasopharyngeal carcinoma Therefore it is necessary to develop more-effective adjuvant therapies
CIK cells cytokine induced killer cells CIK are a population of heterogeneous cells generated by the in vitro amplification of mononuclear cells in peripheral blood The cells are co-induced with multiple cytokines the lymphocytes with co-expression of CD3CD56 have the strongest anti-tumor effect Because of their non-MHC restricted tumor killing activity CIK cells have a powerful anti-tumor effect both in vitro and in vivo which spans a broad anti-tumor spectrum
In this study the patients with post-radiotherapy distant metastasis of NPC will be treated with autologous CIK cells in combination with Gemcitabine plus Cisplatin regimen chemotherapyGC The purpose of this study is to observe and evaluate the toxic side effects and the short- and long-term efficacy of CIK used in combination with GC chemotherapy to treat NPC in patients with distant metastasis after radiotherapy Patients and Methods 40 patients with distant metastasis after radiotherapy will accept 4 cycles chemotherapy of Gemcitabine plus cisplatin regimen and then are randomized divided into 2 groups The 20 patients in GCCIK group will be treated with maintaining therapy of adoptive autologous CIK cell transfusion sequentially the other 20 patients will be followed-up only without CIK cells treatment The safety of chemotherapy and CIK cells transfusion and the tumor regression status will be observed The early response and long-term efficacy of two groups patients who accept GC chemotherapy or GC CIK bio-therapy will be investigated
CIK cells cytokine induced killer cells CIK are a population of heterogeneous cells generated by the in vitro amplification of mononuclear cells in peripheral blood The cells are co-induced with multiple cytokines the lymphocytes with co-expression of CD3CD56 have the strongest anti-tumor effect Because of their non-MHC restricted tumor killing activity CIK cells have a powerful anti-tumor effect both in vitro and in vivo which spans a broad anti-tumor spectrum
In this study the patients with post-radiotherapy distant metastasis of NPC will be treated with autologous CIK cells in combination with Gemcitabine plus Cisplatin regimen chemotherapyGC The purpose of this study is to observe and evaluate the toxic side effects and the short- and long-term efficacy of CIK used in combination with GC chemotherapy to treat NPC in patients with distant metastasis after radiotherapy Patients and Methods 40 patients with distant metastasis after radiotherapy will accept 4 cycles chemotherapy of Gemcitabine plus cisplatin regimen and then are randomized divided into 2 groups The 20 patients in GCCIK group will be treated with maintaining therapy of adoptive autologous CIK cell transfusion sequentially the other 20 patients will be followed-up only without CIK cells treatment The safety of chemotherapy and CIK cells transfusion and the tumor regression status will be observed The early response and long-term efficacy of two groups patients who accept GC chemotherapy or GC CIK bio-therapy will be investigated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None