The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma
Official Title: A Randomized Phase II Trial of Multi-Epitope Vaccination With Melanoma Peptides For Cytotoxic T Cells And Helper T Cells For Patients With Metastatic Melanoma
Study ID: NCT00071981
Brief Summary: RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. PURPOSE: This randomized phase II trial is studying four different vaccines using melanoma peptides from cytotoxic T cells and helper T cells to see how well they work in treating patients with metastatic melanoma.
Detailed Description: OBJECTIVES: * Compare the cytotoxic T-cell response to each of 12 melanoma peptides restricted by Human Leukocyte Antigen (HLA)-A1, -A2, or -A3 in patients with metastatic melanoma vaccinated with or without these 12 melanoma peptides and with or without helper peptides. * Compare the helper T-cell response to each of 6 melanoma helper peptides restricted by HLA-DR molecules in patients treated with these vaccinations. * Determine whether the addition of 6 melanoma helper peptides to a vaccine containing multiple class I Major histocompatibility complex (MHC)-restricted peptides augments T-cell responses to the class I restricted peptides in these patients. * Determine, preliminarily, whether booster vaccination maintains immune response in patients treated with these vaccinations. * Compare the rates of clinical response and survival in patients treated with these vaccinations. * Determine, preliminarily, whether cellular immune response correlates with clinical response and survival rates in patients treated with these vaccinations. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to HLA type (HLA-A1 vs HLA-A2 vs HLA-A1 and -A2 vs HLA-A3) and planned sentinel immunized node biopsy (yes vs no). Patients are randomized to 1 of 4 treatment arms. * Arm I: Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (Granulocyte-macrophage colony-stimulating factor, GM-CSF) and Montanide ISA-51 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. * Arm II: Patients receive 2 injections of multi-epitope peptide vaccine comprising 12MP and 1 tetanus helper peptide emulsified with GM-CSF and ISA-51 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. * Arm III (closed to accrual as of 5/19/08): Patients receive 2 injections of multi-epitope peptide vaccine comprising 12MP and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 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. * Arm IV: Patients receive 2 injections of multi-epitope peptide vaccine comprising 6HP emulsified with GM-CSF and ISA-51 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. In all arms, patients continue therapy in the absence of unacceptable toxicity or disease progression necessitating other urgent therapy. Patients are evaluated at 8 and 12 weeks. Beginning 2-3 weeks after the week-12 evaluation, patients with no evidence of disease progression may receive booster vaccinations according to their randomized treatment arm. Patients receive booster vaccination ID and SC once weekly for 3 weeks. Treatment repeats every 9 weeks for 1 course, every 12 weeks for 2 courses, and then every 24 weeks for 2 courses OR for up to 2 years (whichever comes first) provided the patient does not require an urgent change in therapy. After completion of study treatment, patients are followed every 6 months for 2 years and then for survival for 5 years from study randomization. ACTUAL ACCRUAL: A total of 175 patients were accrued for this study during March 2005 and January 2009.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Veterans Affairs Medical Center - Palo Alto, Palo Alto, California, United States
Stanford Cancer Center, Stanford, California, United States
Tunnell Cancer Center at Beebe Medical Center, Lewes, Delaware, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida, United States
Rush-Copley Cancer Care Center, Aurora, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
Hematology and Oncology Associates, Chicago, Illinois, United States
Midwest Center for Hematology/Oncology, Joliet, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville, Libertyville, Illinois, United States
Cancer Care and Hematology Specialists of Chicagoland - Niles, Niles, Illinois, United States
Hematology Oncology Associates - Skokie, Skokie, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
William N. Wishard Memorial Hospital, Indianapolis, Indiana, United States
Saint Anthony Memorial Health Centers, Michigan City, Indiana, United States
McCreery Cancer Center at Ottumwa Regional, Ottumwa, Iowa, United States
Greater Baltimore Medical Center Cancer Center, Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Union Hospital Cancer Program at Union Hospital, Elkton, Maryland, United States
Borgess Medical Center, Kalamazoo, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Bronson Methodist Hospital, Kalamazoo, Michigan, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota, United States
Minnesota Oncology Hematology, PA - Maplewood, Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
Park Nicollet Cancer Center, Saint Louis Park, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
St. Francis Cancer Center at St. Francis Medical Center, Shakopee, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Minnesota Oncology Hematology, PA - Woodbury, Woodbury, Minnesota, United States
CCOP - Northern New Jersey, Hackensack, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees, New Jersey, United States
Christ Hospital Cancer Center, Cincinnati, Ohio, United States
Case Comprehensive Cancer Center, Cleveland, Ohio, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest, Allentown, Pennsylvania, United States
St. Mary Regional Cancer Center, Langhorne, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia, Philadelphia, Pennsylvania, United States
UPMC Cancer Centers, Pittsburgh, Pennsylvania, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Medical X-Ray Center, PC, Sioux Falls, South Dakota, United States
Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota, United States
Center for Cancer Treatment & Prevention at Sacred Heart Hospital, Eau Claire, Wisconsin, United States
Marshfield Clinic Cancer Care at Regional Cancer Center, Eau Claire, Wisconsin, United States
Gundersen Lutheran Center for Cancer and Blood, La Crosse, Wisconsin, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin, United States
Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, United States
Saint Joseph's Hospital, Marshfield, Wisconsin, United States
Marshfield Clinic - Lakeland Center, Minocqua, Wisconsin, United States
Ministry Medical Group at Saint Mary's Hospital, Rhinelander, Wisconsin, United States
Marshfield Clinic - Indianhead Center, Rice Lake, Wisconsin, United States
Saint Michael's Hospital Cancer Center, Stevens Point, Wisconsin, United States
Marshfield Clinic - Wausau Center, Wausau, Wisconsin, United States
Marshfield Clinic - Weston Center, Weston, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center, Wisconsin Rapids, Wisconsin, United States
Name: Craig L. Slingluff, MD
Affiliation: University of Virginia
Role: STUDY_CHAIR