GC Regimen Chemotherapy Plus CIK Cells for Metastatic Nasopharyngeal Carcinoma

NCT ID: NCT01655628

Last Updated: 2012-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-12-31

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.

Conditions

Stage IV Nasopharyngeal Carcinoma

Keywords

nasopharyngeal carcinoma; metastasis; gemcitabine; CIK cells

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GC chemotherapy plus CIK cells

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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);the other 20 patients will not accept CIK cells treatment. Afer the all 40 patients have accomplished 4 cycles GC regimen chemotherapy plus 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.

GC chemotherapy

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);the other 20 patients will not accept CIK cells treatment. After the all 40 patients have accomplished 4 cycles GC regimen chemotherapy plus 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.

Group Type: ACTIVE_COMPARATOR

GC chemotherapy (Gemcitabine, Cisplatin)

Intervention Type: DRUG

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);the other 20 patients will not accept CIK cells treatment. Afer the all 40 patients have accomplished 4 cycles GC regimen chemotherapy plus 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.

Interventions

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

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);the other 20 patients will not accept CIK cells treatment. Afer the all 40 patients have accomplished 4 cycles GC regimen chemotherapy plus 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.

Intervention Type: DRUG

GC chemotherapy (Gemcitabine, Cisplatin)

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);the other 20 patients will not accept CIK cells treatment. Afer the all 40 patients have accomplished 4 cycles GC regimen chemotherapy plus 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.

Intervention Type: DRUG

Other Intervention Names

Gemcitabine (Zefei) and Cisplatin(Nuoxin) ; Autologous CIK cells; Gemcitabine (Zefei) and Cisplatin (Nuoxin)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Jian-jun Li

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian-jun Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jian-jun Li, M.D. Ph.D

Role: CONTACT

Phone: 86-2087343381

Email: lijj@sysucc.org.cn

Facility Contacts

Jian-jun Li, M.D. Ph.D

Role: primary

Other Identifiers

20120704

Identifier Type: -

Identifier Source: org_study_id