Clinical Trial: Cancer

Melanoma Study with Interferon

Full Name
Melanoma (ECOG #E1609): A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon a-2b for Resected High-Risk Melanoma (2_PRO00000797 - CIRB)

Description

Participants will be randomly assigned to one of three arms. A computer program will place you in one of the arms. Neither the participant nor their doctor will be able to choose to which arm they are assigned. Participants assigned to Arm A will receive ipilimumab at 10 mg/kg. Participants assigned to Arm C will receive ipilimumab at 3 mg/kg. For participants on Arms A and C, the ipilimumab will be given in 2 stages. In the first stage, ipilimumab is given every 3 weeks for a maximum of 4 doses. In the second stage, ipilimumab is given every 12 weeks, beginning at week 24, for a maximum of 4 doses. Participants assigned to Arm B will receive interferon alfa-2b, which will be given in two stages. In the first stage, participants will receive interferon alfa-2b five consecutive days out of 7 every week for 4 weeks by intravenous infusion. In the second stage, participants will receive interferon alpha-2b 3 times a week (every other day) for 48 weeks by subcutaneous (under the skin) injections. In addition to taking the study drug, participants will complete quality of life questionnaires, fill in a study calendar diary, have blood tests, and have physical exams.

Eligibility

Inclusion Criteria
  • Must be >18 years old
  • Must have disease that is completely surgically resected
  • Must be randomized within 84 days (12 weeks) of surgical resection
  • Must not have an active infection requiring treatment with parenteral antibiotics
  • Must not have a documented history of inflammatory bowel disease
Doctor(s) Running This Study

Specialties

  • Hematology/Medical Oncology

Area of focus i

  • Lung Cancer
  • Lymphoma
  • Gastrointestinal Cancer
  • Testicular Cancer

Affiliated with

LVPG Cliniciani

Accepting New Patients