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High-Dose Interferon Alfa in Treating Patients With Stage II or Stage III Melanoma
Bu çalışma, evre II veya evre III melanom (melanoma) olan hastalarda yüksek doz interferon alfa-2b tedavisini gözlem ile karşılaştırmaktadır. Çalışmaya, cerrahi ile çıkarılmış cilt kaynaklı melanomu olan, 18 yaş ve üzeri (ECOG hastalarında 10 yaş ve üzeri) hastalar katılabilmiştir. Çalışma Faz 3 aşamasındadır; şu an katılımcı almamakta ancak devam etmektedir (active, not recruiting).
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
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Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria:
* Histologically confirmed primary melanoma of cutaneous origin
* Stage II (T3 N0 M0 1.5-4.0 mm Breslow depth)
* Clinically negative regional lymph node pathologic status unknown OR
* Histologically negative regional lymph nodes
* Stage III (T4 N0 M0)
* Greater than 4.0 mm 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 1.01-2.0 mm with ulceration, node negative
* T3a-b N0 - primary melanoma 2.01-4.0 mm with and without ulceration, node negative
* T4a-b N0 - primary melanoma \> 4.0 mm with or without ulceration, node negative
* T1a N1a-2a (microscopic) - primary melanoma of any thickness with microscopically positive lymph node (any number)
* Patients with a 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 this study within 84 days of wide excision
* Must have undergone an adequate wide excision of the primary lesion
* Age 18 and over (For ECOG patients only, patients must be \>=10 years)
* Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1
* Adequate hematopoietic, hepatic, and renal function based on the following tests:
* White blood cell (WBC) cout at least 3,000/mm\^3
* Platelet count at least 125,000/mm\^3
* Hematocrit at least 30%
* Bilirubin no greater than 2 times upper limit of normal (ULN)
* Aspartate aminotransferase (AST), lactate dehydrogenase (LDH), and alkaline phosphatase no greater than 2 times ULN
* If lactate dehydrogenase or alkaline phosphatase is above normal, a contrast-enhanced computed tomography (CT) scan or Magnetic resonance imaging (MRI) of the liver is required to document the absence of tumor
* Blood urea nitrogen (BUN) no greater than 33 mg/dL OR Creatinine no greater than 1.8 mg/dL
* No other concurrent or prior malignancies within the past 5 years except:
* Cancer in situ
* Lobular carcinoma in situ of the breast
* Carcinoma in situ of the cervix
* Atypical melanocytic hyperplasia or Clark 1 melanoma in situ
* Basal or squamous cell skin cancer
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study
Exclusion Criteria:
* Clinical, radiological/laboratory, or pathological evidence of incompletely resected melanoma or any distant metastatic disease
* Clinically palpable lymphadenopathy
* Evidence of organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that would preclude study participation
* Other significant medical or surgical condition, or any medication or treatment regimens, that would interfere with study participation
* Pregnant or nursing
* Other history of invasive melanoma
* Autoimmune disorders or conditions of immunosuppression
* History of active ischemic heart disease
* Cerebrovascular disease
* Congestive heart failure (New York Heart Association class III or IV heart disease)
* Prior or concurrent chemotherapy
* Prior immunotherapy including tumor vaccines, interferon, interleukins, levamisole, or other biologic response modifiers for melanoma
* Concurrent systemic corticosteroids including oral steroids (i.e., prednisone, dexamethasone), topical steroid creams or ointments, or any steroid-containing inhalers
* Prior or concurrent radiotherapy
* Other concurrent immunosuppressive medications