Advanced Melanoma
Conditions
Interventions
open-label ,multicenter trial Patients receive GEN0101 (30,000m NAU/day or 60,000 mNAU/day) intratumorally 2 triweekly every 4 weeks (week 1 and 2). One such cycle is repeated 2 cycles.
Sponsors
Department of Dermatology Course of Integrated Medicine Graduate School of Medicine, Osaka University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The patient is Able to understand and sign the Informed Consent Document. 2) The patient is at least more than 20 years and less than 86 years old. 3) The patient has a diagnosis of malignant tumor as confirmed by histopathology or cytology. 4) The patient has a diagnosis of malignant melanoma progressive melanoma in AJCC stage IIIC or stage IV who meets either below condition; Recurrent Refractory or inapplicable to a standard treatment The patient refuses a standard treatment. 5) The patient has measurable or evaluable superficial skin lesions, 10 mm or larger (more than 3 sites and each site must be more than 3mm). 6) The patient has a life expectancy for at least 8 weeks or more. 7) The patient has a ECOG Performance Status Scale of 0 or 2. 8) The organs function adequately evaluated by the following lab values; WBC: equal or more than 2,000/uL PLT: equal or more than 75,000/uL Hemoglobin: equal or more than 8.0 g/dL AST:<local reference range 2.5 ALT:<local reference range 2.5 T-Bil:<local reference range 2 Serum creatinine:<local reference range 2
Exclusion criteria
Exclusion criteria: 1) The patient has multiple brain metastases. 2) The patient shows positive immune response by GEN0101 prick test at screening. 3) The patient has a uncontrolled serious complication such as active infection. 4) Chemotherapy, radiotherapy, local IFN-b therapy, and/or any other therapy with established or suggested anti-cancer effects within 4 weeks (in case of Nitrosoureas or Mitomycin C: within 6 not 4 weeks). 5) Participation in another clinical trial of another investigational medical product within 4 weeks. 6) History of a second independent malignancy within 5 years. 7) History of active autoimmune disease 8) The patient is undergoing on systemic corticosteroids or immunosuppressive agents except for the use of maximum 10 mg/day oral prednisolone over 6 months. 9) The patient is a pregnant or lactating female. 10) The patient has any serious psychiatric disorders that may be unwilling or unable to comply with protocol requirements and scheduled visits. 11) The patient has a history of a transplantation of the allogeneic ogan, the autologous ogan or tissue. 12) The patient shows adequate blood property with PT and APTT more than 1.5 times of the upper limit of local reference range. 13) The patient has hepatitis Be antigen, hepatitis C antibody or human immunodeficiency virus (HIV1,2) antibody positive status. 14) The Patient is inappropriate to be enrolled in this study judged by the doctors in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessing the Safety and Tolerability of GEN0101 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessing the antitumor immunity and validity of GEN0101 | — |
Countries
Japan
Contacts
Public ContactAtsushi Tanemura
Osaka University Hospital Dermatology
Outcome results
None listed