Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma
Melanoma (Skin)

About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma, recurrent melanoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed stage IV melanoma Multiple primary melanomas allowed Metastasis may be from a cutaneous, mucosal, ocular, or unknown primary site Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST criteria) Must have 2 extremities uninvolved with tumor Must have at least 2 intact (undissected) axillary and/or inguinal lymph node basins Prior sentinel node biopsy may not have violated the integrity of a nodal basin This extremity may still be considered for vaccination Human Lymphocyte Antigen (HLA)-A1, -A2, or -A3 positive Prior brain metastases allowed provided all of the following are true: Surgically resected or treated with gamma-knife or stereotactic radiosurgery No disease progression in the brain for the past 3 months More than 30 days since prior steroids for the management of brain metastases Age: 18 and over Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Adequate organ function measured within 4 weeks before randomization: White blood cell (WBC) at least 4,000/mm^3 Platelet count at least 100,000/mm^3 Lymphocyte count at least 700/mm^3 Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) no greater than 2 times upper limit of normal (ULN) Bilirubin no greater than 2 times ULN Alkaline phosphatase no greater than 2 times ULN Lactic dehydrogenase no greater than 2 times ULN Creatinine no greater than 1.8 mg/dL Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except nonmetastatic squamous cell or basal cell skin cancer, ductal or lobular carcinoma in situ of the breast, or carcinoma in situ of the cervix At least 4 weeks since prior sargramostim (GM-CSF), interferon alfa-2b, or interleukin-2 More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) More than 30 days since prior systemic corticosteroids, including any of the following: Therapeutic doses of oral steroids (e.g., prednisone or dexamethasone) Steroid inhalers (e.g., Advair) Topical steroids and nasal steroids with low systemic absorption (e.g., fluticasone) or steroids with low systemic absorption (e.g., triamcinolone hexacetonide) injected into a joint space allowed At least 4 weeks since prior local control or palliative radiotherapy and recovered Recovered from prior major surgery Exclusion criteria: More than 3 brain metastases Metastatic lesions greater than 2 cm Concurrent radiotherapy Prior radiotherapy to measurable disease Concurrent surgery Concurrent corticosteroids Concurrent topical or systemic steroids Concurrent chemotherapy Prior vaccination with any of the study peptides Recent (within the past year) or concurrent addiction to alcohol or illicit drugs Pregnant or nursing Known or suspected major allergy to any components of the study vaccine Significant detectable infection Immunosuppression conditions Prior or active autoimmune disorder requiring cytotoxic or mmunosuppressive therapy, except for any of the following: Presence of laboratory evidence of autoimmune disease (e.g., positive antinuclear antibody (ANA) titer) without symptoms Clinical evidence of vitiligo or other forms of depigmenting illness Mild arthritis requiring nonsteroidal anti-inflammatory medication Autoimmune disorder with visceral involvement
Sites / Locations
- Veterans Affairs Medical Center - Palo Alto
- Stanford Cancer Center
- Tunnell Cancer Center at Beebe Medical Center
- CCOP - Christiana Care Health Services
- Mayo Clinic - Jacksonville
- University of Miami Sylvester Comprehensive Cancer Center - Miami
- Rush-Copley Cancer Care Center
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- Hematology and Oncology Associates
- Midwest Center for Hematology/Oncology
- Joliet Oncology-Hematology Associates, Limited - West
- North Shore Oncology and Hematology Associates, Limited - Libertyville
- Cancer Care and Hematology Specialists of Chicagoland - Niles
- Hematology Oncology Associates - Skokie
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- Indiana University Melvin and Bren Simon Cancer Center
- William N. Wishard Memorial Hospital
- Saint Anthony Memorial Health Centers
- McCreery Cancer Center at Ottumwa Regional
- Greater Baltimore Medical Center Cancer Center
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Union Hospital Cancer Program at Union Hospital
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Minnesota Oncology Hematology, PA - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
- Mayo Clinic Cancer Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- United Hospital
- St. Francis Cancer Center at St. Francis Medical Center
- Ridgeview Medical Center
- Minnesota Oncology Hematology, PA - Woodbury
- CCOP - Northern New Jersey
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
- Cancer Institute of New Jersey at Cooper - Voorhees
- Christ Hospital Cancer Center
- Case Comprehensive Cancer Center
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
- St. Mary Regional Cancer Center
- Fox Chase Cancer Center - Philadelphia
- UPMC Cancer Centers
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sanford Cancer Center at Sanford USD Medical Center
- Center for Cancer Treatment & Prevention at Sacred Heart Hospital
- Marshfield Clinic Cancer Care at Regional Cancer Center
- Gundersen Lutheran Center for Cancer and Blood
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
- Marshfield Clinic - Marshfield Center
- Saint Joseph's Hospital
- Marshfield Clinic - Lakeland Center
- Ministry Medical Group at Saint Mary's Hospital
- Marshfield Clinic - Indianhead Center
- Saint Michael's Hospital Cancer Center
- Marshfield Clinic - Wausau Center
- Marshfield Clinic - Weston Center
- Marshfield Clinic - Wisconsin Rapids Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Arm I (12MP)
Arm II (12MP/Tet)
Arm III (12MP/6MHP)
Arm IV (6MHP)
Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.
Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.