Phase II Trial of TIL Following CCRT in Patients With Locoregionally Advanced NPC (TIL)

October 17, 2016 updated by: Hai-Qiang Mai,MD,PhD, Sun Yat-sen University

A Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes and Concurrent Chemoradiotherapy in Nasopharyngeal Carcinoma

This is a Phase II trial to study the effectiveness and security of cisplatin concurrent chemoradiotherapy plus TIL versus cisplatin concurrent chemoradiotherapy only with IMRT in treating patients with locoregionally advanced high risk nasopharyngeal carcinoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Nasopharyngeal carcinoma (NPC) is endemic in Southern China and Southeast Asia. For locoregionally advanced NPC,especially for the high risk NPC (EB virus DNA ≥ 4000 copies/ml) ,the incidence of treatment failure is still high. Although concurrent chemoradiotherapy (CCRT) can improve the treatment outcomes of these patients, approximately 25% of locoregionally advanced NPCs relapse. Adjuvant chemotherapy or inducing chemotherapy addition to CCRT did not significantly improve patient survival compared to CCRT alone. Hence, there is an urgent need for novel therapies to improve disease-free survival and reduce treatment-related toxicity in patients.

Accumulating evidence shows that tumor-infiltrating lymphocytes (TILs) selected for tumor recognition and greatly expanded in vitro are especially effective for treating cancer patients.The investigations phase I results showed that TILs following CCRT as a novel treatment strategy in locoregionally advanced NPC patients resulted in sustained anti-tumor activity and anti-EBV immune responses, associated with a good tolerance.

This is a Phase II trial to study the effectiveness and security of cisplatin CCRT plus TIL versus cisplatin CCRT only with IMRT in treating patients with locoregionally advanced high risk NPC.

Study Type

Interventional

Enrollment (Anticipated)

116

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Haiqiang Mai
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
  • Original clinical staged as T3-4N1-3 M0 or any T、N2-3M0（according to the 7th AJCC edition）
  • No evidence of distant metastasis (M0)
  • Plasm EB Virus DNA≥4000copies/ml
  • Male and no pregnant female
  • Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1
  • WBC ≥ 4×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
  • With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN)
  • With normal renal function test (Creatinine ≤ 1.5×ULN)

Exclusion Criteria:

  • Patients have evidence of relapse or distant metastasis
  • Histologically confirmed keratinizing squamous cell carcinoma (WHO I)
  • Receiving radiotherapy or chemotherapy previously
  • The presence of uncontrolled life-threatening illness
  • Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
  • Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
  • Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
  • Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).
  • Concurrent systemic steroid therapy
  • HIV positive
  • Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cisplatin+TIL
Cisplatin concurrent chemoradiotherapy(CCRT) combined with tumor-infiltrating lymphocyte (TIL)
Drug: Cisplatin+TIL
cisplatin 100mg/m2(every three weeks),D1,D22,D43 of radiotherapy,then TIL infusing following concurrent chemoradiotherapy
Other Names:
  • DDP
Active Comparator: Cisplatin
Cisplatin concurrent chemoradiotherapy(CCRT) only
Drug: Cisplatin
cisplatin 100mg/m2(every three weeks),D1,D22,D43 of radiotherapy only
Other Names:
  • DDP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progress-free survival
Time Frame: 3 years
Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response (CR)
Time Frame: after the completion of the chemoradiotherapy treatment (up to 9 weeks)
CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the chemoradiotherapy treatment. Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only.
after the completion of the chemoradiotherapy treatment (up to 9 weeks)
Overall Survival (OS)
Time Frame: 3 years
The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
3 years
Locoregional Relapse-Free Survival (LRRF)
Time Frame: 3 years
The LRRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit.
3 years
Distant Metastasis-Free Survival (DMFS)
Time Frame: 3 years
The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.
3 years
Determine the toxic effects in these patients.
Time Frame: 4 weeks
Patients will be monitored for clinical toxicity by standard NIH criteria. A time period of 4 weeks will constitute the time for clinical safety monitoring.
4 weeks
Determine the molecular expression of EBV DNA.
Time Frame: 12 weeks
The molecular expression responses of the patients, including their plasma EBV DNA load, IFN levels and the expansion of EBV-antigen specific T cells.
12 weeks
Determine the quality of life (QoL) of these regimens in these patients.
Time Frame: 4 weeks
Administration and Monitoring Patients will be evaluated in the clinic and eligibility and informed consent obtained. QoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30) and EORTC QLQ Head and Neck.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: HaiQiang Mai, MD,PhD, Cancer center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

April 11, 2015

First Submitted That Met QC Criteria

April 15, 2015

First Posted (Estimate)

April 20, 2015

Study Record Updates

Last Update Posted (Estimate)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 17, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPC and TIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

decided by the results

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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