malignant pleural mesothelioma
Conditions
Interventions
Three graded AdCMV NK4 doses, low dose group (1000000000vp), medium dose group (10000000000vp) and high dose group (100000000000vp), are examined as a dose-escalation study. One dose of AdCMV NK4 will
Sponsors
Graduate School of Medicine, Chiba University
Chiba cancer center Tokyo women'
s univesity Yachiyo medical center Toho university omori medical center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients pathologically diagnosed as malignant pleural mesothelioma Unresectable cases, including recurrence after surgery, or those who reject surgery Recurrent cases or refractory cases to chemotherapies (At least four weeks intervals are required from the last course of chemotherapy) Patients who reject chemotherapies Patients who have not underwent thoracic radiotherapy previously Patients with written informed consent, those fully explained about the study using a document ECOG Performance status 0 to 1 Patients with not being pregnant nor lactating. Patients who agree to contraception during the study period, and/or those agree to inform their doctors whenever they or their spouse get pregnant Patients with life expectancy longer than 3 months Patients who have an enough space in thoracic cavity for viral injection Patients who are considered safe to participate to the study, approved by the principle investigator or the collaborators Patients with enough organic functions and laboratory findings as follows White Blood Cell >= 3000/mm3, or Neutrophils >=2000/mm3 Platelet >=10x104/mm3 Hemoglobin <=9.0/dl Total Bilirubin <= x 1.5 of upper-limit of normal range ALT(GOT)/AST(GPT) <= x 2 of upper-limit of normal range Alkaline phosphatase <=x5 of upper-limit of normal range Creatinine <1.5mg/dl PT and APTT: within normal range SPO2 at breathing room air >=92% Electric cardiogram: within normal range
Exclusion criteria
Exclusion criteria: Patients with active or uncontrolled infectious diseases and /or the severe complications Patients who have another malignancy besides malignant mesothelioma, synchronous or metachronous. Patients who have achieved complete cure or have progression free interval longer than 2 years are acceptable Patients who have symptomatic brain metastatic foci and / or require a treatment for it Patients who do not have enough intra-thoracic room for viral injection Patients who have participated in other clinical trial with approved or unapproved medicine within 4 weeks before the entry in this study Patients who are scheduled to receive another anticancer drug during the study period Patients who have already treated with pleurodesis for mesothelioma Patients who have peripheral nerve palsy more than grade 2 in CTCAE vers 4.0 at the entry Patients who have apparent interstitial diseases and pulmonary fibrosis on chest X ray Patients who have any problems including mental, familial, social or geographic issues that prevent good compliance to achieve this study Patients who have already undergone a treatment using adenoviral vectors Patients who have a treatment history of auto or allograft organ transplantation Patients who are positive for HIV antigen, HBV antigen, HCV antibody, and HTLV 1 antibody Patients who are judged as inappropriate to participate this study by the principal investigator and the collaborators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of frequency of the adverse events and limiting toxicity (DLT) | — |
Secondary
| Measure | Time frame |
|---|---|
| antitumor effect (response to the treatment) | — |
Countries
Japan
Contacts
Public ContactYuji Tada
Graduate School of Medicine, Chiba University Department of Respirology
Outcome results
None listed