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A Phase III Trial Evaluating Chemotherapy and Immunotherapy for Advanced Nasopharyngeal Carcinoma (NPC) Patients
Not Recruiting
Trial ID: NCT02578641
Purpose
This study is a multi-center, randomized, open label, Phase III clinical trial for advanced
Nasopharyngeal Carcinoma(NPC) Patients.
Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to
stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving an infusion of a person's cytotoxic T cells (CTL) that have been treated in
the laboratory may help the body build an effective immune response to kill tumor cells.
Giving combination chemotherapy together with laboratory-treated T cells may kill more tumor
cells. This Phase III trial is to assess if combined gemcitabine-carboplatin (GC) followed by
adoptive T-cell therapy would improve clinical outcome for patients with advanced
nasopharyngeal carcinoma (NPC). It is also the world's first, and largest, Phase 3 T-cell
therapy cancer trial ever conducted, and enrollment is ongoing for 330 patients from 30
hospital centers across Asia and the United States.
This clinical trial is conducted on the back of a successful Phase 2 NPC trial involving 38
patients at the National Cancer Centre, Singapore. This trial produced the best published
2-year (62.9%), and median overall survival (OS) data (29.9 months) in 35 patients with
advanced NPC who received autologous EBV-specific CTL. Kindly see
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3978790/ for the Phase 2 publication titled
"Adoptive T-cell Transfer and Chemotherapy in the First line treatment of Metastatic and/or
Locally Recurrent Nasopharyngeal Carcinoma".
Official Title
A Multicentre, Randomized, Open-Label, Phase III Clinical Trial Of Gemcitabine And Carboplatin Followed By Epstein-Barr Virus-Specific Autologous Cytotoxic T Lymphocytes Versus Gemcitabine And Carboplatin As First Line Treatment For Advanced Nasopharyngeal Carcinoma(NPC) Patients
Stanford Investigator(s)
A. Dimitrios Colevas, MD
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
Eligibility
Key Inclusion Criteria
1. Metastatic or locally recurrent EBV-positive, non-keratinizing and/ or
undifferentiated NPC* who do not have curative options such as chemo-radiation or
surgery
*Subjects will be enrolled based on confirmed histology diagnosis of the NPC
2. Radiologically measurable disease as per RECIST 1.1
3. Human Immunodeficiency Virus (HIV) negative*
* Status of HIV must be confirmed via a HIV antibody test or other confirmatory tests
available within 4 weeks of screening
4. Bilirubin <2 x upper limit of normal (ULN) and aspartate aminotransferase (AST),
alanine aminotransferase (ALT) <3 x ULN
5. Calculated creatinine clearance (CRCL) ≥40 mL/min. Glomerular Filtration Rate (GFR) is
calculated based on Cockcroft-Gault method.
6. Normal corrected calcium levels
7. Absolute neutrophil count >1200/mm3, hemoglobin (Hb) ≥10 g/dL and platelets
≥100,000/mm3
8. Male or female
9. Age ≥ 18 years or according to local legal age of consent
10. Eastern Cooperative Oncology Group Performance Scale (ECOG-PS) ≤2
11. Written informed consent
12. Life expectancy >6 months
Key Exclusion Criteria
1. Severe concomitant illness i.e. chronic obstructive pulmonary disease (COPD), ischemic
heart disease (IHD), active congestive cardiac failure (CCF), active angina pectoris,
uncontrolled arrhythmia, uncontrolled hypertension
2. HIV Positive*
* Status of HIV must be confirmed via a HIV antibody test or other confirmatory tests
available within 4 weeks of screening
3. Pregnant or lactating females
4. Refuse of use of contraception during trial (both male and female patients)
5. Investigational therapy less than one month prior to study entry
6. Pre-existing peripheral neuropathy (National Cancer Institute Common Terminology
Criteria for Adverse Events [NCI CTCAE] ≥2)
7. Central nervous system metastasis
8. Previous or concurrent cancer that is distinct in primary site or histology from the
cancer being evaluated in this study, EXCEPT cervical carcinoma in situ, treated basal
cell carcinoma, superficial bladder tumors [Ta, Tis and T1] or any cancer curatively
treated >3 years prior to study entry
9. Positive hepatitis B surface antigen (HBsAg) results
10. Known history of hepatitis C and recovery status has not been determined at time of
screening
11. Prior anti-cancer treatment for metastatic or locally recurrent disease, EXCEPT:
For metastatic or locally recurrent disease, localised palliative radiotherapy is
allowed.
For locally recurrent disease, the following treatment is allowed
- Prior radiotherapy with curative intent
- Prior chemo-radiotherapy with curative intent
- Adjuvant chemotherapy
- Localised palliative radiotherapy Prior chemotherapy must be > 6 months before
screening
12. Severe intercurrent infections
13. Prior immunotherapy for metastatic or locally recurrent disease
The following is allowable:
• Adjuvant immunotherapy/ biologics Prior adjuvant immunotherapy/ biologics must be > 6
months before screening
Intervention(s):
drug: combination IV gemcitabine and IV carboplatin (AUC2)
biological: autologous EBV specific Cytotoxic T cells
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Elizabeth Winters
650-721-6509