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Status:

COMPLETED

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

Lead Sponsor:

Eastern Cooperative Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Melanoma (Skin)

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 pepti...

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    May 9 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2014

    Estimated Enrollment :

    175 Patients enrolled

    Trial Details

    Trial ID

    NCT00071981

    Start Date

    May 9 2005

    End Date

    January 1 2014

    Last Update

    June 28 2023

    Active Locations (65)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 17 (65 locations)

    1

    Veterans Affairs Medical Center - Palo Alto

    Palo Alto, California, United States, 94304

    2

    Stanford Cancer Center

    Stanford, California, United States, 94305-5824

    3

    Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, United States, 19958

    4

    CCOP - Christiana Care Health Services

    Newark, Delaware, United States, 19713