High-Dose Interferon Alfa in Treating Patients With Stage II or Stage III Melanoma

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

DISEASE CHARACTERISTICS:

  • 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:
    • T_2b N_0 - primary melanoma 1.01-2.0 mm with ulceration, node negative
    • T_3a-b N_0 - primary melanoma 2.01-4.0 mm with and without ulceration, node negative
    • T_4a-b N_0 - primary melanoma > 4.0 mm with or without ulceration, node negative
    • T_1-a N_1a-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
  • No clinical, radiological/laboratory, or pathological evidence of incompletely resected melanoma or any distant metastatic disease
  • No clinically palpable lymphadenopathy

PATIENT CHARACTERISTICS:

  • 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 upper limit of normal (ULN)
    • AST, LDH, and alkaline phosphatase no greater than 2 times ULN
    • If lactate dehydrogenase or alkaline phosphatase 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 33 mg/dL OR
    • Creatinine no greater than 1.8 mg/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)
  • Other:
    • No other history of invasive melanoma
    • No autoimmune disorders or conditions of immunosuppression
    • 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
    • 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

PRIOR CONCURRENT THERAPY:

  • Biologic therapy: No prior immunotherapy including tumor vaccines, interferon, interleukins, levamisole, or other biologic response modifiers for melanoma
  • Chemotherapy: No prior or concurrent chemotherapy
  • Endocrine therapy: No concurrent systemic corticosteroids including oral steroids (i.e., prednisone, dexamethasone), topical steroid creams or ointments, or any steroid-containing inhalers
  • Radiotherapy: No prior or concurrent radiotherapy
  • Surgery: See Disease Characteristics
  • Other: No other concurrent immunosuppressive medications

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Svetomir Markovic, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Svetomir Markovic, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Svetomir Markovic, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions