Clinical trial NCT01655628: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stage IV Nasopharyngeal Carcinoma
Keywords: nasopharyngeal carcinoma
metastasis
gemcitabine
CIK cells
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2012-08-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Complete remission (CR)
timeFrame: Participants will accept 4cycles GC regimen chemotherapy (every 4 weeks) plus 8 cycles CIK cells treatment (every 4 weeks), a total of therapy time will be 12 months.
measure: Partial remission (PR)
timeFrame: Participants will accept 4cycles GC regimen chemotherapy (every 4 weeks) plus 8 cycles CIK cells treatment (every 4 weeks), a total of therapy time will be 12 months.
measure: Stable disease (SD)
timeFrame: Participants will accept 4cycles GC regimen chemotherapy (every 4 weeks) plus 8 cycles CIK cells treatment (every 4 weeks), a total of therapy time will be 12 months.
measure: Progressive disease (PD)
timeFrame: Participants will accept 4cycles GC regimen chemotherapy (every 4 weeks) plus 8 cycles CIK cells treatment (every 4 weeks), a total of therapy time will be 12 months.
Secondary outcomes:
measure: overall survival time (OS)
timeFrame: Paticipants will be follow-up 2 years afer they have accomplished 4 cycles GC chemotharapy /or GC chemotharapy plus CIK cells treatment.
measure: time to progression (TTP)
timeFrame: Paticipants will be follow-up 2 years afer they have accomplished 4 cycles GC chemotharapy /or GC chemotharapy plus CIK cells treatment.
measure: progression free survival(PFS)
timeFrame: Paticipants will be follow-up 2 years afer they have accomplished 4 cycles GC chemotharapy /or GC chemotharapy plus CIK cells treatment.
Other outcomes:
Locations:
city: Guangzhou city
country: China
facility: Cancer Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Jian-jun Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References: