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

Completed · Phase 2

Conditions studied: Melanoma (Skin)

In brief

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.

Key facts

Study ID

NCT00071981

Run by

Eastern Cooperative Oncology Group

People needed

175

Starts

2005-05-09

Expected to finish

2014-01-01

Last updated by the study team

2023-06-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

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:
• 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

Where it is running

• 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
• Veterans Affairs Medical Center - Palo Alto — Palo Alto, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.