CTSU E1609 melanoma

CTSU E1609: A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon a-2b for Resected High-Risk Melanoma

Type of Study
Cancer (Oncology) - Melanoma
Location
Swedish Cancer Institute
Short Description

Purpose: This phase III clinical trial is studying ipilimumab or high-dose interferon alfa-2b in treating patients with high-risk stage III or stage IV melanoma that has been removed by surgery.

Status
Temporarily Closed
Principal Investigator
Gary Goodman, M.D.
Eligibility Notes
  • Diagnosis of melanoma of a cutaneous origin or unknown primary
    • No ocular melanoma or melanoma of mucosal origin
  • Stage IIIB, IIIC, or IV (M1a or M1b) disease (including recurrent disease)
    • Patients with stage IV melanoma must have normal LDH and distant skin, subcutaneous, lymph node, or lung metastases
    • No other visceral metastases allowed
  • Patients with unknown primary melanoms (Tx) who present with cutaneous, subcutaneous, nodal and/or lung metastases that re completely surgically resected with free margins are allowed
  • Disease that has been completely resected with negative margins on resected specimens within the past 12 weeks
  • Patients with clinically positive lymph nodes for melanoma involvement or those with positive lymph nodes identified through lymphoscintigraphic and/or dye lymphographic techniques in the groin, axilla, or neck should have additional lymphadenectomy in those sites
  • No documented history of inflammatory bowel disease, including ulcerative colitis and Crohn disease, or diverticulitis
  • No active or chronic infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV)
  • No prior adjuvant treatment (chemotherapy, biotherapy, or limb perfusion) after resection
  • At least 21 days since prior radiotherapy, including after surgical resection
  • No prior or concurrent anti-CTLA4 monoclonal antibodies, CTLA-4 inhibitor or agonist, CD137 agonist, or prior interferon-α
  • At least 4 weeks since prior aldesleukin (IL-2), anti-tumor vaccine, or chemotherapy given before randomization
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
Phone
(206) 215-3086
Email
CancerResearch@Swedish.org