Study of Cytolytic Viral Activation Therapy (CVAT) for Recurrent/Metastatic Nasopharyngeal Carcinoma

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Brief Title

Study of Cytolytic Viral Activation Therapy (CVAT) for Recurrent/Metastatic Nasopharyngeal Carcinoma

Official Title

Phase I Study of Cytolytic Viral Activation Therapy (CVAT) for Recurrent/Metastatic Nasopharyngeal Carcinoma

Brief Summary

      Nasopharyngeal carcinoma (NPC) is an Epstein-Barr virus(EBV) related malignancy and is an
      endemic disease in Southeast Asian countries. EBV had been identified as a therapeutic target
      in some EBV related cancer such as lymphoma and NPC. In cancer cell, EBV was in latent phase
      and expressed 8-11 genes for maintaining EBV proliferation. After switching to lytic phase,
      almost all the EBV encoding genes were expressed including thymidine kinase (TK) and some
      highly immunogenetic genes. These latent-lytic phase swifter included DNA methyltransferase
      inhibitors, various histone deacetylase (HDAC) inhibitors, radiotherapy and chemotherapy.
      Recently, combined chemotherapy and viral lytic therapy, cytolytic viral activation therapy
      (CVAT) had been shown some promising result in pilot study of NPC. In our patient derived
      xenograft (PDX) animal model drug sensitivity screening, gemcitabine (GEM) was shown to be
      the most effective drug. Furthermore, CVAT with GEM + Valproic acid (VPA) + ganciclovir (GCV)
      maintaining chemotherapy may benefit but reduce chemotherapy related side effect and
      prolonging treatment response duration. The following phase I clinical trial will be proposed
      to test the optimal combination of these drugs.

        1. Number of patients: total 18 patients are needed

        2. Inclusion criteria:(1) used as 2nd line regimen in recurrence/metastasis NPC patients
           with tissue proved of World Health Organization (WHO) type II or type III.(2)
           Performance status: eastern cooperative oncology group performance status (ECOG PS) ≤2.

        3. Chemotherapy regimen: Gemcitabine (GEM, TTY) + Valproic acid (VPA, generic medicine) for
           viral activation + Valganciclovir (VGC, Roche) for antiviral medication

        4. This treatment cycle of 28 days was repeated maximum 6 times. (Q4wks/cycle, max: 6
           cycles)

        5. Dosage:

      (1) GEM: 600, 800, 1000, 1250 mg/m^2, D1 & D8, intravenously. (2) VPA 12.5 mg/kg/day D1~14,
      per os. (3) VGC (2-3) x 450 mg/day D9~15, per os. 6. Objectives:

        1. primary: to find the best combination of these 3 drugs in recurrent/metastatic NPC
           patients.

        2. second: to evaluate the response and disease control rate in this pilot study.

      Key words: NPC, cytolytic viral activation therapy, gemcitabine, valproic acid, ganciclovir.
    

Detailed Description

      1. Introduction to investigational treatment(s) and other study treatment(s)

           1.1 Overview of gemcitabine Gemcitabine (29,29-difluoro 29-deoxycytidine, dFdC) which
           developed from cytosine arabinoside (Ara-C) is an nucleoside analog used as
           chemotherapy. It was intended as an antiviral drug in initial, but preclinical testing
           showed that it killed leukemia cells and a spectrum of solid tumor in vitro. In cell,
           gemcitabine undergoes complex intracellular conversion to the active forms of
           nucleotides gemcitabine diphosphate (dFdCDP) and triphosphate (dFdCTP) that will
           influence DNA synthesis. dFdCTP competes with deoxycytidine triphosphate (dCTP) and
           dFdCDP is a potent inhibitor of ribonucleoside reductase (1). Gemcitabine is
           administered by the intravenous route with dose ranges from 0.6-1.2 g/m^2 of body
           surface area (2), and has been used in a broad spectrum cancer management including
           lung, breast, pancrease, and bladder (3).

           The toxic profile of gemcitabine was major in hematopoietic system especially
           neutropenia and thrombocytopenia (4). In NPC treatment, gemcitabine had been the focus
           of several reports, with interesting OR rates in the range of 23-48% and median
           progression-free survival (PFS) of between 3.6 and 5.1 months (5). In combination
           chemotherapy with cisplatin, the OR rate 42.7 to 73% had been reported and median PFS
           were 5.6 to 10.6 months (6). In combined with oxaliplatin, the OR rate was 56.1 % and
           median PFS was 9 months (6). In combined with vinorelbine, OR rate 36 to 37.7% had been
           reported and median PFS were 5.2 to 5.6 months. In multiple drugs combination with
           carboplatin, paclitaxel, 5-Fluoro-Uracil/LeucoVorin, high OR rate with 86% had been
           reported but with median PFS of 8 months (6). Still these trials were done in small
           series and lacking randomized large scale phase III trial.

           1.2 Valproic acid (VPA) Valproic acid (VPA), a branched short-chain fatty acid, is
           widely used in clinical as an antiepileptic drug and a mood stabilizer, primarily in the
           treatment of epilepsy, bipolar disorder, and prevention of migraine headaches (7). The
           antiepileptic properties of VPA have been attributed to inhibition of Gamma Amino
           Butyrate (GABA) trans aminobutyrate and of ion channels.

           VPA was recently classified among the Histone Deacetylase (HDAC) inhibitors, acting
           directly at the level of gene transcription by inhibiting histone deacetylation and
           making transcription sites more accessible. Chromatin is formed of DNA packaged in
           nucleosome structures. The condensed form of chromatin (heterochromatin) is inactive in
           terms of transcription whereas the decondensed form (euchromatin) corresponds to an
           active form. The histone acetylation leads to relaxation of the nucleosome structure,
           releasing the DNA and allowing transcription. Inhibition of histone deacetylases (HDACs)
           promotes decondensed chromatin formation, thereby promoting the expression of genes (7).

           Valproic acid (VPA), as a HDAC inhibitor, can specifically target at class I a, I b, and
           II a HDACs (8). VPA also down regulates expression of proteins essential for chromatin
           maintenance: Structural Maintenance of chromatin (SMC), DNA methyl transferase-1
           (DNMT1), and heterochromatin protein-1 (HP1) (9). VPA had been shown to induce histone 3
           methylation which would increase transcriptional activity (8). VPA had been shown some
           anticancer effect, major through its HDAC inhibitor, in single agent or combined with
           other anticancer medication including myeloid and lymphoid malignancies, breast cancer,
           prostate cancer, and NPC (10-13) Long-term VPA treatment may cause central nervous
           system (CNS) dysfunction, liver toxicity, and coagulopathy including thrombocytopenia
           and platelet dysfunction (7).

           1.3 Ganciclovir (GCV) and Valganciclovir (VGC) GCV was an antiviral agent had been used
           in treatment or prophylaxis of cytomegalovirus infection in solid organ transplantation
           recipients or bone marrow transplantation (14). GCV is a synthetic analogue of
           2'-deoxy-guanosine and can be phosphorylated to ganciclovir triphosphate, a competitive
           inhibitor of deoxyguanosine triphosphate (dGTP) incorporation into DNA and
           preferentially inhibits viral DNA polymerases more than cellular DNA polymerases, by
           viral and cell kinase. In addition, ganciclovir triphosphate serves as a poor substrate
           for chain elongation, thereby disrupting viral DNA synthesis by a second route (15).

           VGC, a valyl ester prodrug of GCV, had a high oral bioavailability of about 60% with
           similar efficacy of GCV in management of cytomegalovirus infection (16). The most common
           side effect of IV GCV is fever and leukopenia (16).

           1.4 Combination of GEM, VPA and GCV in NPC treatment In EBV-related malignancy,
           antiviral drugs exhibit no direct effect on cancer cell except when used combined with
           epigenetically active agents (17, 18). Recently, Wildeman et al, had shown some efficacy
           by combining chemotherapy of GEM with VPA and GCV in control of locally
           advanced/metastatic NPC patients (13). In this article, both GEM and VPA could shift EBV
           from latent phase into lytic phase and had synergetic effect when combined used. Further
           adding GCV in this regimen could suppress virion formation. The combination therapy had
           been tested in three locally advanced/metastatic NPC patients showing promising results
           with tumor regressing/stable in image and plasma EBV DNA load monitoring with few side
           effects Similar manageable side effects of these three drugs combined treatment were
           also proved by Stoker et al (19). These results encouraged us to develop a more
           practical regimen in this trial.

        2. Test products, dosage, and mode of administration:

      2.1. Chemotherapy regimen: Gemcitabine (Gemmis injection,200 mg) (GEM, TTY) + Valproic acid
      (Depakine gastro-resistant tablet,200 mg) (VPA, Sanofi) for viral activation + Valganciclovir
      (Valcyte film-coated tablets,450 mg) (VGC, Roche) for antiviral medication

      2.2. Dosage GEM: 600~1250 mg/m^2, D1 & D8, intravenously. VPA: 12.5 mg/kg/day D1~14, per os.
      VGC: (2~3) x 450mg/day D9~15, per os.

        1. This treatment cycle of 28 days will be repeated maximum 6 times. (Q4wks/cycle, max: 6
           cycles)

        2. Four dosage of GEM combined with fixed dosage of VPA and VGC will be tested

        3. The rationale of seven days treatment duration of VGC come from (A) 7 days treatment
           duration of valacyclovir in herpes zoster in immunocompetent patients (20) (B) overlap
           side effect of myelosuppression between GEM and VGC(13).

        4. Efficient dose intensity chemotherapy (gemcitabine) is essential in this three combined
           drugs regimen (21) and this trial will be started with dose level 0 (Gemcitabine 800
           mg/m^2)

      2.3. Concomitant treatment

      2.3.1 Permitted: The related treatment for relieve symptoms caused from tumor.

      2.3.2 Prohibited:

        1. Radiation therapy, operation, and other chemotherapy for eradicating tumor

        2. Valganciclovir concomitant with Imipenem-cilastatin could result in convulsion; with
           zidovudine could result in neutropenia; with Probenecid would increase toxicity of
           ganciclovir

        3. Co-administration of valproate with amitryptyline/nortryptyline, and warfarin need to be
           adjusted if necessary

        4. Co-administration of valganciclovir with didanosine, Mycophenolate mofetil, and bone
           marrow suppression drugs (e.g., dapsone, pentamidine, flucytosine, vincristine,
           vinblastine, adriamycin, amphotericin B, nucleoside analogues, hydroxyurea) would need
           to be monitored more seriously because of their toxicity might increase

        5. All other drugs prohibited co-administration with valproic acid absolutely

      3. Duration of treatment: This treatment cycle of 28 days will be repeated maximum 6 times.
      (Q4wks/cycle, max: 6 cycles) A standard 3 + 3 phase I dose escalation study design was used
      (22). A minimum of three evaluable patients were to be treated at each dose level. According
      to Worst Toxicity CTCAE v4.03 Grade and FDA indication of gemcitabine, the dose limiting
      toxicity (DLT) of this trial was determined in the first treatment cycle.

      In the absence of DLT, patients were enrolled in the next dose level. If 1 of three patients
      had a DLT, the cohort was expanded to include six patients. If ≥2 patients experienced DLT,
      maximum tolerated dose (MTD) was exceeded and further enrollment at that dose level was
      stopped. MTD was defined as the highest dose level at which ≤1 of 6 patients experienced a
      DLT. Only DLT that occurred during the first treatment cycle were used to determine the MTD.

      4. Patient examination and re-evaluation: Laboratory data of complete blood count
      (CBC)/differential count (DC), creatinine, alanine aminotransferase (ALT) will be routine
      checked every weeks during the first 3 treatment cycles. During all treatment courses, if
      grade 4 neutropenia or grade 4 thrombocytopenia attacked, the laboratory will be checked
      every 3 days until recovered to pre-treatment baseline. Around 70% responsive and stable
      cases could be enrolled in the 4th treatment cycle will be routine checked the laboratory
      data before gemcitabine administration. Plasma EBV DNA copies number will be monitored before
      each cycle treatment. Systemic re-evaluation will be performed after every three cycles
      treatment. Re-evaluation including physical examination, image studies including CT/MRI for
      head and neck area, chest x-ray, abdominal echo, and Gallium whole body tumor scan, and blood
      exam including complete CBC count, biochemical profile, and plasma EBV DNA copies number.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Number of participants suffered dose limiting toxicity (DLT) that are related to this treatment

Secondary Outcome

 Safety and tolerability assessed by adverse events, serious adverse events

Condition

Nasopharyngeal Carcinoma

Intervention

Gemcitabine

Study Arms / Comparison Groups

 gemcitabine dose escalation
Description:  In three combined drugs used in nasopharyngeal carcinoma, the valproic acid and valganciclovir administration will be followed by indication to find the maximum tolerance dose of gemcitabine.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

18

Start Date

May 2016


Primary Completion Date

June 2017

Eligibility Criteria

        Inclusion Criteria:

          1. Have the ability to understand and willingness to sign a written informed consent
             document

          2. Identified as recurrent nasopharyngeal carcinoma or distant metastases of male or
             female subjects who had failed in 1st line therapy including radiotherapy, not
             suitable for radiotherapy or unwilling to receive radiotherapy, 1st line chemotherapy
             excluding gemcitabine, and no curative treatment options

          3. Biopsy confirmed belong to World Health Organization classification of nasopharyngeal
             carcinoma type II or type III

          4. Men and women between aged 20 to 80 years of age; female patients with childbearing
             potential will routinely consult obstetric doctor for contraception and need to have
             contraception at least 6 months after finished this trial

          5. Adequate internal organs including liver, kidney and bone marrow function

               -  white blood cell count of >3,000/µL; platelet count of ≥100,000/µL; absolute
                  neutrophil count >1,500/µL

               -  total bilirubin <2.0 mg/dL, aspartate aminotransferase (AST), alanine
                  transaminase(ALT) <2.5x upper limit of normal range (ULN)

               -  serum creatinine <2.0 mg/dL

          6. The daily performance status ECOG ≤ 2 points

        Exclusion Criteria:

          1. Pregnancy or breast-feeding women, and plans within six months of pregnancy

          2. Contraindication to Gemmis injection, Depakine gastro-resistant tablet, and Valcyte
             film-coated tablets, including:

               -  Allergy to Gemmis injection, Depakine gastro-resistant tablet, Valcyte
                  film-coated tablets, and other similar drugs

               -  Patients with hepatic B or C, patients with human immunodeficiency virus, or
                  viral related disease receiving anti-viral treatment

               -  Acute or chronic hepatitis not related to NPC with liver metastasis

               -  Using drugs which ineligible combination with valproic acid, including
                  mefloquine, St.-John's-Wort, lamotrigine, Topiramate, quetiapine, cyclosporin,
                  hepatic enzyme-inducing drugs (e.g., phenytoin, carbamazepine phenobarbital,
                  primidone, rifampin), enzyme inhibitors (e.g., felbamate), aspirin, cimetidine,
                  erythromycin, carbapenem (e.g., Panipenem, Aztreonam, Imipenem, Meropenem),
                  diazepam, ethosuximide, lamotrigine, phenytoin, nimodipine

          3. With insomnia, anxiety or spiritual concerns, or are receiving mental illness
             treatment

          4. Has been diagnosed with a second cancer, except to basal cell carcinoma

          5. Patients unsuitable to this trial, including:

               -  Patients with significant disease

               -  PI evaluated with high risk group patients

               -  Patients not recovered from previous anti-cancer treatment

               -  Recent major surgery

          6. Patients with creatinine clearance rate <40 ml/min
      

Gender

All

Ages

20 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Cheng-Lung Hsu, Physican, (886)3-3281200, [email protected]

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations


NCT ID

NCT02761291

Organization ID

104-4750A


Responsible Party

Sponsor

Study Sponsor

Chang Gung Memorial Hospital

Collaborators

 TTY Biopharm

Study Sponsor

Cheng-Lung Hsu, Physican, Principal Investigator, Chang Gung Memorial Hospital


Verification Date

March 2016