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

NCT00071981 | Completed Phase 2 Results

• 3 other identifiers: CDR0000335055U10CA021115E1602
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 65

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.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Outcome Measures

Primary Outcomes (1)

• Cytotoxic T-cell Lymphocytes (CTL) Response Rate

  Assessment of CTL response was based on a fold-increase in T cell response measure by interferon-gamma ELIspot assay.

  Immune response was assessed at pre-registrtion, in weeks 1, 3, 5, 7, 8

Secondary Outcomes (4)

• Helper T-cells Response to 6MHP

  Immune response was assessed at pre-registration, in weeks 1,3,5,7,8

• Helper T Cell Response to Tetanus

  Immune response was assessed at pre-registration, in weeks 1,3,5,7,8

• Objective Response Rate

  Tumor response was assessed in weeks 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 6 months after last vaccination

• Median Overall Survival (OS)

  assessed every 3 month within 2 years and every 6 months betwen 2 and 5 years

Study Arms (4)

Arm I (12MP)

EXPERIMENTAL

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.

Biological: incomplete Freund's adjuvant; Biological: multi-epitope melanoma peptide vaccine; Biological: sargramostim

Arm II (12MP/Tet)

EXPERIMENTAL

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.

Biological: incomplete Freund's adjuvant; Biological: multi-epitope melanoma peptide vaccine; Biological: sargramostim; Biological: tetanus peptide melanoma vaccine

Arm III (12MP/6MHP)

EXPERIMENTAL

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.

Biological: incomplete Freund's adjuvant; Biological: melanoma helper peptide vaccine; Biological: multi-epitope melanoma peptide vaccine; Biological: sargramostim

Arm IV (6MHP)

EXPERIMENTAL

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.

Biological: incomplete Freund's adjuvant; Biological: melanoma helper peptide vaccine; Biological: sargramostim

Interventions

incomplete Freund's adjuvant BIOLOGICAL

Given by injection

Also known as: Montanide ISA-51

Arm I (12MP); Arm II (12MP/Tet); Arm III (12MP/6MHP); Arm IV (6MHP)

melanoma helper peptide vaccine BIOLOGICAL

Given by injection

Also known as: 6 melanoma helper peptides restricted by class II MHC molecules, restricted by, HLADR molecules,, 6 class II MHC-Restricted Melanoma-Associated Peptides

Arm III (12MP/6MHP); Arm IV (6MHP)

multi-epitope melanoma peptide vaccine BIOLOGICAL

Given by injection

Also known as: 12 Melanoma peptides from melanocyte differentiation protein (MDP) and cancer testis antigen (CTA),, 12 melanoma peptides restricted by class I MHC molecules,restricted by HLA-A1, A2, or A3 molecules

Arm I (12MP); Arm II (12MP/Tet); Arm III (12MP/6MHP)

sargramostim BIOLOGICAL

Given by injection

Also known as: rhu GM-CSF,, Leukine,, Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)

Arm I (12MP); Arm II (12MP/Tet); Arm III (12MP/6MHP); Arm IV (6MHP)

tetanus peptide melanoma vaccine BIOLOGICAL

Given by injection

Also known as: Modified Tetanus p2 peptide restricted by class II MHC molecules,, Peptide-Tet

Arm II (12MP/Tet)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (65)

Veterans Affairs Medical Center - Palo Alto

Palo Alto, California, 94304, United States

Location

Stanford Cancer Center

Stanford, California, 94305-5824, United States

Location

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

Location

Rush-Copley Cancer Care Center

Aurora, Illinois, 60504, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Hematology and Oncology Associates

Chicago, Illinois, 60611, United States

Location

Midwest Center for Hematology/Oncology

Joliet, Illinois, 60432, United States

Location

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, 60435, United States

Location

North Shore Oncology and Hematology Associates, Limited - Libertyville

Libertyville, Illinois, 60048, United States

Location

Cancer Care and Hematology Specialists of Chicagoland - Niles

Niles, Illinois, 60714, United States

Location

Hematology Oncology Associates - Skokie

Skokie, Illinois, 60076, United States

Location

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

William N. Wishard Memorial Hospital

Indianapolis, Indiana, 46202, United States

Location

Saint Anthony Memorial Health Centers

Michigan City, Indiana, 46360, United States

Location

McCreery Cancer Center at Ottumwa Regional

Ottumwa, Iowa, 52501, United States

Location

Greater Baltimore Medical Center Cancer Center

Baltimore, Maryland, 21204, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Union Hospital Cancer Program at Union Hospital

Elkton, Maryland, 21921, United States

Location

Borgess Medical Center

Kalamazoo, Michigan, 49001, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007-3731, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, 55432, United States

Location

Minnesota Oncology Hematology, PA - Maplewood

Maplewood, Minnesota, 55109, United States

Location

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

Robbinsdale, Minnesota, 55422-2900, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Park Nicollet Cancer Center

Saint Louis Park, Minnesota, 55416, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

St. Francis Cancer Center at St. Francis Medical Center

Shakopee, Minnesota, 55379, United States

Location

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

Location

Minnesota Oncology Hematology, PA - Woodbury

Woodbury, Minnesota, 55125, United States

Location

CCOP - Northern New Jersey

Hackensack, New Jersey, 07601, United States

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

Christ Hospital Cancer Center

Cincinnati, Ohio, 45219, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

Allentown, Pennsylvania, 18105, United States

Location

St. Mary Regional Cancer Center

Langhorne, Pennsylvania, 19047, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

UPMC Cancer Centers

Pittsburgh, Pennsylvania, 15232, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Medical X-Ray Center, PC

Sioux Falls, South Dakota, 57105, United States

Location

Sanford Cancer Center at Sanford USD Medical Center

Sioux Falls, South Dakota, 57117-5039, United States

Location

Center for Cancer Treatment & Prevention at Sacred Heart Hospital

Eau Claire, Wisconsin, 54701, United States

Location

Marshfield Clinic Cancer Care at Regional Cancer Center

Eau Claire, Wisconsin, 54701, United States

Location

Gundersen Lutheran Center for Cancer and Blood

La Crosse, Wisconsin, 54601, United States

Location

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449, United States

Location

Saint Joseph's Hospital

Marshfield, Wisconsin, 54449, United States

Location

Marshfield Clinic - Lakeland Center

Minocqua, Wisconsin, 54548, United States

Location

Ministry Medical Group at Saint Mary's Hospital

Rhinelander, Wisconsin, 54501, United States

Location

Marshfield Clinic - Indianhead Center

Rice Lake, Wisconsin, 54868, United States

Location

Saint Michael's Hospital Cancer Center

Stevens Point, Wisconsin, 54481, United States

Location

Marshfield Clinic - Wausau Center

Wausau, Wisconsin, 54401, United States

Location

Marshfield Clinic - Weston Center

Weston, Wisconsin, 54476, United States

Location

Marshfield Clinic - Wisconsin Rapids Center

Wisconsin Rapids, Wisconsin, 54494, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

incomplete Freund's adjuvant; montanide ISA 51; dipeptidase 1; sargramostim; Colony-Stimulating Factors; Granulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Study Statistician
• Organization: Eastern Cooperative Oncology Group (ECOG) Statistical Office

617-632-3012

Study Officials

• Craig L. Slingluff, MD

  University of Virginia

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2003
• First Posted: November 6, 2003
• Study Start: May 9, 2005
• Primary Completion: August 1, 2011
• Study Completion: January 1, 2014
• Last Updated: June 28, 2023
• Results First Posted: January 3, 2013

Record last verified: 2023-06

Locations

US (65)