Cutaneous melanoma
Conditions
Interventions
A: Patients receive intra or sub-cutaneous injection of interferon beta at a flat dose of 3MU around primary site once a day. Treatment repeats for 10 consecutive days every 8 weeks for a total of 3 c
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients must be histologically confirmed as having primary cutaneous melanoma. 2) Patients must belong to pathological stage of II or III in the 7th AJCC-TNM classification. 3) Patients must have undergone curative surgery within 9 weeks prior to enrollment. 4) Primary melanoma must be completely resected with clear margins. 5) Patients who underwent sentinel lymph node (SLN) biopsy must fulfill one of the following conditions: a) SLNs were examined using immunohistochemistry (HMB-45 and/or MART-1/Melan A) in addition to routine H&E stain, and histologically confirmed as negative for metastasis. b) Patients with positive SLNs must have undergone an adequate complete lymph node dissection (CLND). The number of harvested lymph nodes must be equal or more than 15 in neck, 10 in axilla, and 5 in groin. 6) Patients with clinically positive lymph nodes must have undergone an adequate CLND. The number of harvested lymph nodes must be equal or more than 15 in neck, 10 in axilla, and 5 in groin. 7) No history of previous treatment for malignancy. 8) No history of treatment using any kind of interferon. 9) Patients are aged from 20 to 80 years old at the time of enrollment. 10) Patients with the ECOG performance status 0 or 1. 11) Patients must have adequate organ and marrow function as defined below within 28 days prior to enrollment: a) Absolute neutrophil count >= 1,200 /mm3 b) Hemoglobin >= 8.0 g/dL c) Platelets >= 10X104 /mm3 d) Total bilirubin =< 2.0 mg/dL e) AST=< 100 IU/L f) ALT=< 100 IU/L g) Creatinine =< 1.5 mg/dL 12) Patients who provide a personally signed and dated informed consent document.
Exclusion criteria
Exclusion criteria: 1) Patients with a concurrent malignancy (within 5 years) except for carcinoma in situ or basal cell carcinomas which were curatively treated with local therapy. 2) Patients with ongoing or active infection which requires systemic therapy. 3) Patients with a fever at equal or more than 38 degree Celsius. 4) Pregnant, possible pregnant, or lactating women. Within 28 days after childbirth. 5) Patients with a psychiatric illness or social situations that would limit compliance with study requirements. 6) Patients who are receiving systemic administration of steroid or other immunosuppressants. 7) Patients with an unstable angina pectoris or history of cardiac infarction within 6 months. 8) Patients with an uncontrolled diabetes mellitus, or continuously treated with insulin. 9) Patients with positive HIV antibody. 10) Patients with interstitial pneumonia, severe pulmonary fibrosis, or emphysema. 11) Patients have a history of an autoimmune hepatitis. 12) Patients who are taking Shosaikoto (a herbal drug). 13) Patients who have a history of allergy to materials of interferon beta, materials derived from cow, or biological drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence-free survival, Distant metastasis-free survival, pattern of recurrence, adverse events | — |
Countries
Japan
Contacts
Public ContactKenjiro Namikawa
JCOG1309 Coordinating Office Department of Dermatologic Oncology, National Cancer Center Hospital
Outcome results
None listed