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(E1697) PHASE III RANDOMIZED STUDY OF FOUR WEEKS HIGH DOSE IFN-2b in Stage T2b No, T3a-b No, T4a-b No, and T1-4, N1a, 2a, 3 (microscopic) MELANOMA

NCT No.: NCT00003641

Study Type: INTERVENTIONAL

Phase: Phase III

Region: Colorado

Acronym: 

Official Title

(E1697) PHASE III RANDOMIZED STUDY OF FOUR WEEKS HIGH DOSE IFN-2b in Stage T2b No, T3a-b No, T4a-b No, and T1-4, N1a, 2a, 3 (microscopic) MELANOMA

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

Sex

Male & Female

Age Limit

Eligibility Criteria

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

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

Keywords and/or Specific Medical Conditions

  • Allergy and Immunology
  • Dermatology
  • Oncology (Adult)

Sponsors

  • ECOG-ACRIN Cancer Research Group

KP Clinical Facility

Clinical Area

  • Allergy and Immunology
  • Dermatology
  • Oncology (Adult)

Principal Investigator

Alex Menter  

Contact Information

 - CTP Team
- ctpcollaborate@kp.org
- Lone Tree Medical Offices - Lone Tree

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