Phase III Randomized Study of Four Weeks High Dose IFN-2b in StageT3-T4 or N1 (Microscopic) Melanoma
Inclusion Criteria:
- Histologically confirmed primary melanoma of cutaneous origin
- Stage II (T3 N0 M0 1.5-4.0mm Breslow depth
- Clinically negative regional lymph node pathologic status unkown OR
- Histologically negative regional lymph nodes
- Stage III (T4 N0 M0)
- Greater than 4.0mm Breslow depth OR
- Stage III (T1-4 N1)
- One lymph node positive microscopically
- Patients must meet at least 1 of the following criteria
- T2b N0 primary melanoma 1.01-2.0mm with ulceration, node negative
- T3a-b N0 primary melanoma 2.01-4.0mm with and without ulceration, node
negative
- T4a-b N0 primary melanoma > 4.0mm with and without ulceration, node negative
- T1aN1a-2a (microscopic)-primary melanoma of any thickness with microscopically
positive lymph node (any number)
- Note EORTC patients who are node negative T2 or T3 are ineligible
- Patients with positive sentinel node should undergo complete lymphadenectomy of the
nodal basin prior to study
- Must complete all primary therapy (wide excision with or without lymphadenectomy) and
be randomized in the study within 84 days of wide excision
- No clinical, radiological/laboratory, or pathological evidence of incompletely
resected melanoma or any distant metastatic disease
- No clinically palpable lymphadenopathy
Age:
- 18 and over
Performance Status:
- ECOG 0-1
Life expectancy:
- Not specified Hematopoietic
- WBC at least 3,000/mm^3
- Platelet count at least 125,000/mm^3
- Hematocrit at least 30%
Hepatic:
- Bilirubin no greater than 2 times the upper limit of normal (ULN)
- AST, LDH, and Alkaline phosphate no greater than 2 times ULN
- If lactate dehydrogenase or alkaline phosphate is above normal, a contrast enhanced
CT scan or MRI of the liver is required to document the absence of tumor
Renal:
- BUN no greater than 33mg/dl OR
- Creatinine no greater than 1.8mg/dl
Cardiovascular:
- No history of active ischemic heart disease
- No cerebrovascular disease
- No congestive heart failure(New York Heart Association class III or IV heart disease)
Exclusion Criteria:
Biologic Therapy:
- No prior immunotherapy including tumor vaccines, interferon, interleukins,levamisole,
or other biologic response modifers for melanoma Chemotherapy
- No prior or concurrent chemotherapy Endocrine Therapy
- No concurrent systemic corticosteriods including oral steriods (i.e., prednisone,
dexamethasone), topical steroid creams or ointments, or any steriod-containing
inhalers.
Radiotherapy:
- No Prior or concurrent radiotherapy
Surgery:
- See Disease characteristics
Other:
- No other concurrent immunosuppressive medications
- No other history of invasive melanoma
- No autoimmune disorders or conditions of immunosuppression
- No other concurrent or prior malignancies within past 5 years
- Cancer in situ
- Lobular carcinoma in situ of breast
- Carcinoma in situ of the cervix
- Atypical melanocytic hyperplasia or Clark 1 melanoma in situ
- Basal or squamous cell skin cancer
- No evidence of organic brain syndrome or significant impairment of basal cognitive
function or any psychiatric disorder that would preclude study participation
- No other significant medical or surgical condition, or any medication or treatment
regimens, that would interfere with study participation.
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study