Aldesleukin With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Melanoma
Recurrent Melanoma, Stage IIIA Skin Melanoma, Stage IIIB Skin Melanoma
About this trial
This is an interventional treatment trial for Recurrent Melanoma
Eligibility Criteria
Inclusion Criteria: Any patient with measurable metastatic (stage IV or locally advanced stage III) cutaneous melanoma and an expected survival of greater than three months will be considered Serum creatinine of 1.6 mg/dl or less Total bilirubin 1.6 mg/dl or less White blood cell (WBC) 3000/mm^3 or greater Platelet count 90,000 mm^3 or greater Serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less then three times normal Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Patients of both genders must be willing to practice effective birth control during this trial Pathologic confirmation of cutaneous melanoma; patients may enter the study with a pathologic diagnosis of cutaneous melanoma from any institution; all slides will be reviewed at National Institutes of Health (NIH) (department of Anatomic Pathology) and if the diagnosis is not confirmed, the patient will be excluded from the study Tissue type human leukocyte antigen (HLA) A0201 Exclusion Criteria: Patients who have types of melanoma other than cutaneous, i.e. ocular or mucosal Patients who are undergoing or have undergone in the past 4 weeks any other form of therapy except surgery for their cancer, including radiation therapy to any site Patients who have active systemic infections, coagulation disorders, autoimmune disease or history of other major medical illnesses such as insulin dependent diabetes mellitus, cardiac ischemia, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary diseases and inflammatory bowel disorders Patients who have significant psychiatric disease which in the opinion of the principal investigator would prevent adequate informed consent or render immunotherapy unsafe or contraindicated Patients who require steroid therapy or steroid-containing compounds, or have used systemic steroids in the past 4 weeks, or have used topical or inhalational steroids in the past 2 weeks Patients who are pregnant Patients who are known to be positive for viral hepatitis B or C (hepatitis B surface antigen [HBsAg] or anti hepatitis C virus [HCV]) or human immunodeficiency virus (HIV) (HIV antibody) Patients who have any form of primary or secondary immunodeficiency Patients who have received previous high dose IL-2 (> 600,000 IU/kg) Patients who have received previous gp100 vaccines Patients who have an abnormal stress cardiac test (stress thallium, stress multi gated acquisition scan [MUGA], dobutamine echocardiogram or other stress test that will rule out cardiac ischemia) Patients who have abnormal pulmonary function tests (forced expiratory volume in one second [FEV1] < 65% or forced vital capacity [FVC] < 65% of predicted) Patients who have brain metastasis or history of brain metastasis No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for 5 years
Sites / Locations
- University of Alabama at Birmingham
- Mayo Clinic in Arizona
- Kaiser Permanente Medical Center
- University of Colorado Cancer Center - Anschutz Cancer Pavilion
- Lakeland Regional Cancer Center
- Emory University/Winship Cancer Institute
- Northwestern University
- Rush University Medical Center
- Advocate Lutheran General Hospital.
- IU Health Goshen Center for Cancer Care
- The James Graham Brown Cancer Center at University of Louisville
- National Institutes of Health
- Carolinas Medical Center
- The Christ Hospital
- Ohio State University Comprehensive Cancer Center
- Saint Luke's University Hospital-Bethlehem Campus
- Penn State Milton S Hershey Medical Center
- M D Anderson Cancer Center
- Aurora Saint Luke's Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I (aldesleukin)
Arm II (gp100 antigen in Montanide IDA-51 and aldesleukin)
Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.
Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.