GC Regimen Chemotherapy Plus CIK Cells for Metastatic Nasopharyngeal Carcinoma

Brief Title

GC Regimen Chemotherapy Plus CIK Cells for Metastatic Nasopharyngeal Carcinoma

Official Title

Autologous Cytokine-Induced Killer Cell Transfusion in Combination With Gemcitabine Plus Cisplatin Regimen Chemotherapy for Metastatic Nasopharyngeal Carcinoma

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 CD3+CD56+ 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
      chemotherapy(GC). 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 GC+CIK 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.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Complete remission (CR)

Secondary Outcome

 overall survival time (OS)

Condition

Stage IV Nasopharyngeal Carcinoma

Intervention

GC chemotherapy plus CIK cells (Gemcitabine, Cisplatin, Autologous CIK cells)

Study Arms / Comparison Groups

 GC chemotherapy plus CIK cells

Description:  A total of 40 patients enrolled will be accept 4 cycles GC chemotherapy(every 4 weeks),then they will randomized divided into two groups. 20 patients will maintain autologous CIK cells for 8 cycles (every 4 weeks); however,the other 20 patients will not accept CIK cells treatment. After the all 40 patients have accomplished 4 cycles GC regimen chemotherapy plus 8 cycles CIK cells treatment or 4 cycles GC chemotherapy alone, the early effects will be assessed and long-term efficacy such as OS and PFS will be evaluated.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

40

Start Date

July 2012

Completion Date

December 2014

Primary Completion Date

July 2014

Eligibility Criteria

        Inclusion Criteria:

          1. The primary lesions of all patients were classified as undifferentiated,
             non-keratinizing carcinoma at the initial stage for treatment (WHO, 1991 criteria) and
             no distant metastasis was observed based on imaging studies before radiotherapy ;

          2. all patients had received standard doses of radiotherapy, were regularly followed-up
             after radiotherapy, and had distant metastatic lesions revealed by imaging studies;

          3. metastases were found more than 6 months after the end of radiotherapy, with the
             expected survival time of more than 3 months;

          4. in each case, no more than 10 metastatic lesions were found in the imaging studies;

          5. Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1;

          6. the bone marrow functioned normally (WBC > 4.0×109/L, Hb > 120 g/L, PLT > 100×109/L);

          7. the ECG results were normal, and the liver and kidney were functional.

        Exclusion Criteria:

          1. Patients were excluded if they had central nervous system metastases;

          2. uncontrolled infection; underlying disease that was severe or life-threatening;

          3. the patients were pregnant or lactating;

          4. ECOG perform status ≥ 2;

          5. the patients who are suffering from auto immune diseases or patients who need to
             accept glucocorticoid treatment.
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Jian-jun Li, M.D., 86-2087343381, [email protected]

Location Countries

China

Location Countries

China

NCT ID

NCT01655628

Organization ID

20120704

Responsible Party

Principal Investigator

Study Sponsor

Sun Yat-sen University

Study Sponsor

Jian-jun Li, M.D., Principal Investigator, Sun Yat-sen University

Verification Date

July 2012