ECOG-1697

Phase III randomised adjuvant study of high-dose INF alfa-2b v observation for stage II or III melanoma. The objectives are to compare the effect on the relapsefree, overall, quality-adjusted survival and assess the toxicity. Target is 1420 patients.

Contact person: Dr Pauline Hanrahan, Newcastle Melanoma Unit ,phone: 02 4985 0179 or Sue-Ellen, Sydney West Cancer Trials Centre, Westmead Hospital, Phone: 02 9845 8988 Email: sue-ellen_delforce@wmi.usyd.edu.au

INCLUSION CRITERIA

  • Patients must meet at least 1 of the following criteria:
    • T2bN0 – primary melanoma 1.01 – 2.0 mm with ulceration, node -ve
    • T3a-bN0 - primary melanoma 2.01 – 4.0 mm with and without ulceration, node -ve
    • T4a-bN0 - primary melanoma > 4.0 mm with or without ulceration, node -ve
    • T1-4 N1a,2a,3 - primary any thickness with microscopically +ve LN (any number)
  • Patients with +ve SNB should undergo complete lymphadenectomy prior to study
  • Must complete all primary therapy (WE +/- LND) & randomised ≤ 84 days of WE
  • No evidence of incompletely resected melanoma or distant metastatic disease
  • No clinically palpable lymphadenopathy
  • No other history of invasive melanoma
  • No prior or concurrent immunotherapy, chemotherapy or radiotherapy
  • No concurrent systemic corticosteroids including oral, topical or any steroidcontaining inhalers or other immunosuppressive medications
  • Age ≥ 18 years with a Performance status ECOG 0 – 1
  • AST, LDH, ALP and Bilirubin ≤ 2 x ULN – CT or MRI of liver required if LDH or ALP > normal
  • BUN ≤ 33 mg/dL or Creatinine ≤ 1.8 mg/dL
  • WBC ≥ 3,000/mm3, Platelet ≥ 125,000/mm3 and Hematocrit ≥ 30%
  • No history of active ischemic heart/cerebrovascular disease or congestive heart failure
  • No autoimmune disorders or conditions of immunosuppression
  • No other concurrent or prior malignancies < 5 years except; lobular carcinoma in situ of the breast, carcinoma in situ of cervix, atypical melanocytic hyperplasia or Clark 1 melanoma in situ, BCC or SCC
  • 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 breast feeding.

 

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