|
| Overall Recruitment Status: Enrollment complete |
| |
| Official Title |
| Phase III Randomized Study of Four Weeks of High Dose Interferon Alfa-2b in Stage T2bN0, T3a-bN0, T4a-bN0, and T1-4, N1a,2a (Microscopic) Melanoma
|
| |
| Region |
Sponsors |
| California - Northern |
|
| |
| Acronym |
NCT No. |
|
NCT00003641 |
| |
| Study Type |
Phase |
| INTERVENTIONAL |
|
| |
| Purpose |
| PURPOSE: This randomized phase III trial is studying high dose interferon alfa to see how well it works compared to observation only in treating patients with stage II or stage III melanoma that has been completely removed by surgery.
|
| |
| Detailed Description |
|
| |
| |
| |
- 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
|
|
| |
- 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
|
|
| |
|
|
| |
|