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Spots Global Cancer Trial Database for Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma

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Trial Identification

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

Conditions

Melanoma (Skin)

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Craig L. Slingluff, MD

Affiliation: University of Virginia

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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