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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
Overall Recruitment Status: Active, enrollment completed
 
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
ECOG-ACRIN Cancer Research Group
 
Acronym KP IRB No.
CN-03LFehr-11-B
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Melanoma (Skin);
 
Purpose
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not yet known whether treatment with interferon alfa is more effective than observation alone for stage II or stage III melanoma that has been completely removed surgically. 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
 
Gender Age Limit
Male & Female
 
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.
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study
  • Please contact study personnel for more Inclusion Criteria
 
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

 
Keywords and/or Specific Medical Conditions
  • Melanoma
  • Oncology (Adult)
 
KP Clinical Facility
  • Fremont Medical Center
  • Hayward Medical Center
  • Oakland Medical Center
  • Redwood City Medical Center
  • Richmond Medical Center
  • Roseville Medical Center
  • Sacramento Medical Center
  • San Francisco Medical Center
  • San Rafael Medical Center
  • Santa Clara Medical Center-Homestead
  • Santa Rosa Medical Center
  • Vallejo Medical Center
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Tatjana Kolevska, MD
Contact Information:


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