Sargramostim, Vaccine Therapy, or Sargramostim and Vaccine Therapy in Preventing Disease Recurrence in Patients With Melanoma That Has Been Removed By Surgery
Iris Melanoma, Medium/Large Size Posterior Uveal Melanoma, Mucosal Melanoma
About this trial
This is an interventional prevention trial for Iris Melanoma
Eligibility Criteria
Inclusion Criteria:
- Patients must have HLA-A2 status known prior to randomization; typing may be obtained through a local laboratory facility or through a reference lab utilized by the initiating institution; if typing is not available through these means, it may be obtained from the University of Pittsburgh
All patients must have disease completely resected with one of the following in order to be eligible:
- Completely resected disease
- Any locoregional recurrence after prior adjuvant interferon or failure on S008
- Any local recurrence of disease after adequate surgical excision of the original primary
- Mucosal melanoma
- Stage IV melanoma (cutaneous, ocular, mucosal, or unknown primary)
The following groups of patients may be entered onto this trial only if they are ineligible for S0008 or are, in the opinion of the managing physician, medically unfit to receive standard high-dose interferon:
- Any clinically evident satellite or in-transit disease
- Stage II disease with gross extracapsular extension
- Recurrence in a previously resected nodal basin
- Four or more involved lymph nodes or matted lymph nodes
Ulcerated primary melanoma and any involved lymph nodes
- NOTE: Patients who are eligible for S0008 will be strongly encouraged to participate in that study in preference to this one
- Patients must have been surgically rendered free of disease with negative margins on resected specimens; patients rendered free of disease by non-surgical means are not eligible
- Patients must be randomized within 112 days (16 weeks) of surgical resection; if more than one surgical procedure is required to render the patient disease-free, all required surgeries must be accomplished within this 16 week time period
- Patients must not have received any adjuvant treatment (chemotherapy, biotherapy, or limb perfusion) after the resection(s) that make(s) them eligible for this trial; one systemic treatment after a prior surgery is allowed, and must have been completed >= 8 weeks prior to randomization; (when chemotherapy and biotherapy are given together as one planned treatment [biochemotherapy], this counts as one regimen); NOTE: Previous radiation therapy, including after the resection, is allowed as long as 30 days elapse between the radiation and initiation of therapy
- Prior treatment with GM-CSF or any peptides used in this protocol, is not allowed
- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Patients must not have an active infection requiring treatment with parenteral antibiotics
- Patients must not have other significant medical, surgical, or psychiatric conditions or require any medication or treatment that may interfere with compliance on any of the E4697 treatment regimens
- Patients must not have a diagnosis or evidence of organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that might preclude participation in the full protocol
- Patients must be able to self-administer or arrange for administration of subcutaneous injections
- Patients who have other current malignancies are not eligible
- Patients with prior history at any time of any in situ cancer, lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ are eligible; patients who meet this criteria must be disease-free at time of randomization
- Patients with prior history of basal or squamous skin cancer are eligible; patients who meet this criteria must be disease-free at time of randomization
- Patients who have had multiple primary melanomas are eligible
- Patients with other malignancies are eligible if they have been continuously disease free for > 5 years prior to the time of randomization
- Patients must not have autoimmune disorders, conditions of immunosuppression or treatment with systemic corticosteroids, including oral steroids (i.e., prednisone, dexamethasone), continuous use of topical steroid creams or ointments, or any steroid containing inhalers; replacement doses of steroids for patients with adrenal insufficiency are allowed; patients who discontinue use of these classes of medication for at least 2 weeks prior to randomization are eligible if, in the judgment of the treating physician, the patient is not likely to require these classes of drugs during the study
- Women of childbearing potential must not be pregnant (negative beta human chorionic gonadotropin [bHCG] within 2 weeks prior to randomization) or breast-feeding
- Women of childbearing potential and sexually active males must be counseled to use an accepted and effective method of contraception (including abstinence) while on treatment and for a period of 18 months after completing or discontinuing treatment
- All patients must have brain computed tomography (CT) or magnetic resonance imaging (MRI), chest CT or chest x-ray (CXR), and abdominal (liver) CT or MRI within 4 weeks prior to randomization; positron emission tomography (PET) scans are also acceptable in place of CT, CXR and/or abdominal MRI if obtained within 4 weeks prior to randomization; patients with lesions on the lower extremity must also have pelvic imaging within this time period; this is also strongly recommended for patients with lesions on the lower trunk; PET scans are acceptable
- Patients with resection of visceral disease must have imaging of the affected area/organ documenting disease-free status within 2 weeks prior to randomization
- White blood cells (WBC) >= 3,000/mm?
- Platelet count >= 100,000/mm?
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2 x institutional upper limit (IUL) of normal
- Bilirubin =< 2 x IUL of normal
- Serum creatinine =< 1.8 mg/dl
- Alkaline phosphatase and lactate dehydrogenase (LDH) must be performed within 4 weeks prior to randomization; LDH must be normal; patients with abnormal alkaline phosphatase which is =< 1.25 times the institutional upper limit of normal who have a negative CT or MRI of the liver and negative bone scan or a negative PET scan are eligible
- Patients with bone pain must have a bone scan within 4 weeks prior to randomization to document the absence of tumor
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- Mobile Infirmary Medical Center
- Mayo Clinic in Arizona
- Banner University Medical Center - Tucson
- University of Arkansas for Medical Sciences
- Alta Bates Summit Medical Center-Herrick Campus
- City of Hope Comprehensive Cancer Center
- UC San Diego Moores Cancer Center
- Saint Joseph Hospital - Orange
- Stanford Cancer Institute Palo Alto
- VA Palo Alto Health Care System
- University of California Davis Comprehensive Cancer Center
- Kaiser Permanente-San Diego Mission
- Naval Medical Center -San Diego
- Veterans Administration-San Diego Medical Center
- The Medical Center of Aurora
- Boulder Community Hospital
- SCL Health Saint Joseph Hospital
- Swedish Medical Center
- Saint Mary's Hospital and Regional Medical Center
- Manchester Memorial Hospital
- Southwest Florida Regional Medical Center
- Baptist MD Anderson Cancer Center
- Mayo Clinic in Florida
- Jupiter Medical Center
- Lakeland Regional Health Hollis Cancer Center
- Mount Sinai Medical Center
- AdventHealth Orlando
- Florida Cancer Specialists-West Palm Beach
- Cleveland Clinic-Weston
- Emory University Hospital/Winship Cancer Institute
- Augusta University Medical Center
- Atlanta VA Medical Center
- Eisenhower Army Medical Center
- Medical Center of Central Georgia
- South Georgia Medical Center/Pearlman Cancer Center
- Saint Luke's Mountain States Tumor Institute
- Rush - Copley Medical Center
- Northwestern University
- University of Chicago Comprehensive Cancer Center
- Loyola University Medical Center
- Memorial Medical Center
- Carle Cancer Center
- Indiana University/Melvin and Bren Simon Cancer Center
- IU Health Methodist Hospital
- IU Health Ball Memorial Hospital
- McFarland Clinic PC - Ames
- Genesis Medical Center - East Campus
- Iowa Methodist Medical Center
- Iowa-Wide Oncology Research Coalition NCORP
- Medical Oncology and Hematology Associates-Des Moines
- Siouxland Regional Cancer Center
- University of Kansas Cancer Center
- Wichita NCI Community Oncology Research Program
- The James Graham Brown Cancer Center at University of Louisville
- Ochsner Health Center-Summa
- Ochsner Medical Center Jefferson
- Eastern Maine Medical Center
- Anne Arundel Medical Center
- Greater Baltimore Medical Center
- Sinai Hospital of Baltimore
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Tufts Medical Center
- Massachusetts General Hospital Cancer Center
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Institute
- Franklin Medical Center
- Baystate Medical Center
- University of Michigan Comprehensive Cancer Center
- Cancer Research Consortium of West Michigan NCORP
- West Michigan Cancer Center
- North Memorial Medical Health Center
- Mayo Clinic
- Hattiesburg Clinic - Hematology/Oncology Clinic
- University of Missouri - Ellis Fischel
- Saint Louis-Cape Girardeau CCOP
- Cancer Research for the Ozarks NCORP
- Saint Vincent Healthcare
- Montana Cancer Consortium NCORP
- CHI Health Saint Francis
- Nebraska Methodist Hospital
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Creighton University Medical Center
- University of Nebraska Medical Center
- University Medical Center of Southern Nevada
- Nevada Cancer Research Foundation CCOP
- Dartmouth Hitchcock Medical Center
- Veterans Adminstration New Jersey Health Care System
- The Cancer Institute of New Jersey Hamilton
- Rutgers Cancer Institute of New Jersey
- University of New Mexico Cancer Center
- Montefiore Medical Center-Wakefield Campus
- Glens Falls Hospital
- Orange Regional Medical Center
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- Interlakes Foundation Inc-Rochester
- University of Rochester
- Stony Brook University Medical Center
- New York Medical College
- Carolinas Medical Center/Levine Cancer Institute
- Novant Health Presbyterian Medical Center
- Duke University Medical Center
- Wayne Memorial Hospital
- Southeast Clinical Oncology Research (SCOR) Consortium NCORP
- Mid Dakota Clinic
- Sanford Bismarck Medical Center
- Aultman Health Foundation
- University of Cincinnati/Barrett Cancer Center
- Case Western Reserve University
- MetroHealth Medical Center
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- Dayton NCI Community Oncology Research Program
- Cancer Centers of Southwest Oklahoma Research
- Saint John Medical Center
- Natalie Warren Bryant Cancer Center at Saint Francis
- Providence Portland Medical Center
- Lehigh Valley Hospital-Cedar Crest
- Saint Luke's University Hospital-Bethlehem Campus
- Geisinger Medical Center
- Delaware County Memorial Hospital
- Saint Mary Medical and Regional Cancer Center
- Paoli Memorial Hospital
- University of Pennsylvania/Abramson Cancer Center
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- University of Pittsburgh Cancer Institute (UPCI)
- Pottstown Hospital
- Guthrie Medical Group PC-Robert Packer Hospital
- Medical University of South Carolina
- Sanford Cancer Center Oncology Clinic
- East Tennessee State University
- Vanderbilt University/Ingram Cancer Center
- Medical City Dallas Hospital
- Huntsman Cancer Institute/University of Utah
- University of Vermont and State Agricultural College
- Skagit Valley Hospital
- Kaiser Permanente Washington
- Swedish Medical Center-First Hill
- West Virginia University Charleston Division
- Aurora Cancer Care-Glendale
- Saint Vincent Hospital Cancer Center Green Bay
- University of Wisconsin Hospital and Clinics
- Holy Family Memorial Hospital
- Marshfield Medical Center-Marshfield
- ProHealth Oconomowoc Memorial Hospital
- ProHealth Waukesha Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm I (sargramostim, peptide vaccine)
Arm II (sargramostim placebo, peptide vaccine)
Arm III (sargramostim, peptide placebo)
Arm IV (placebo, peptide placebo)
Arm V (sargramostim)
Arm VI (sargramostim placebo)
Patients receive sargramostim SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
Patients receive sargramostim placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
Patients receive sargramostim SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
Patients receive placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
Patients receive sargramostim SC on days 1-14.
Patients receive sargramostim placebo SC on days 1-14.