Trial Search Results

A Phase III Trial Evaluating Chemotherapy and Immunotherapy for Advanced Nasopharyngeal Carcinoma (NPC) Patients

The purpose of this study is to evaluate the efficacy of T-cell therapy following first line chemotherapy (Gemcitabine And Carboplatin) for recurrent/metastatic disease, in prolonging overall survival of patients with advanced NPC compared to just chemotherapy alone. The other purposes of the study are to determine the efficacy of T-cell therapy versus chemotherapy alone, in delaying disease progression, improve quality of life and overall response and clinical benefit in patients with advanced NPC.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Tessa Therapeutics

Stanford Investigator(s):

Intervention(s):

  • Biological: autologous EBV specific Cytotoxic T cells
  • Drug: combination IV gemcitabine and IV carboplatin (AUC2)

Phase:

Phase 3

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Elizabeth Winters
650-721-6509
Not Recruiting