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

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), August 2008

Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00071981
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin)
Drug: incomplete Freund's adjuvant
Drug: melanoma helper peptide vaccine
Drug: multi-epitope melanoma peptide vaccine
Drug: sargramostim
Drug: tetanus peptide melanoma vaccine
Phase II

MedlinePlus related topics:   Cancer    Melanoma   

ChemIDplus related topics:   Sargramostim    Granulocyte-macrophage colony-stimulating factor    Freund's adjuvant    Montanide ISA 51   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Active Control
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Immune response as measured by amount of peripheral blood T-cell lymphocytes present over the first 6 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical response as measured by amount of helper T-cells present at week 8 [ Designated as safety issue: No ]

Estimated Enrollment:   176
Study Start Date:   March 2005
Estimated Primary Completion Date:   February 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Arm I: 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 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.
Drug: incomplete Freund's adjuvant
Given by injection
Drug: multi-epitope melanoma peptide vaccine
Given by injection
Drug: sargramostim
Given by injection
Arm II: Experimental
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.
Drug: incomplete Freund's adjuvant
Given by injection
Drug: multi-epitope melanoma peptide vaccine
Given by injection
Drug: sargramostim
Given by injection
Drug: tetanus peptide melanoma vaccine
Given by injection
Arm III: Experimental
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.
Drug: incomplete Freund's adjuvant
Given by injection
Drug: melanoma helper peptide vaccine
Given by injection
Drug: multi-epitope melanoma peptide vaccine
Given by injection
Drug: sargramostim
Given by injection
Arm IV: Experimental
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.
Drug: incomplete Freund's adjuvant
Given by injection
Drug: melanoma helper peptide vaccine
Given by injection
Drug: sargramostim
Given by injection

Detailed Description:

OBJECTIVES:

  • Compare the cytotoxic T-cell response to each of 12 melanoma peptides restricted by 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 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 (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: 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.

PROJECTED ACCRUAL: A total of 176 patients (44 per treatment arm) will be accrued for this study within 3 years.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage IV melanoma

    • Multiple primary melanomas allowed
    • Metastasis may be from a cutaneous, mucosal, ocular, or unknown primary site
  • Measurable disease by 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
  • HLA-A1, -A2, or -A3 positive
  • Prior brain metastases allowed provided all of the following are true:

    • No more than 3 brain metastases
    • Metastatic lesions no greater than 2 cm
    • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • WBC at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Lymphocyte count at least 700/mm^3

Hepatic

  • SGOT and 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

Renal

  • Creatinine no greater than 1.8 mg/dL

Immunologic

  • No known or suspected major allergy to any components of the study vaccine
  • No significant detectable infection
  • No immunosuppression conditions
  • No prior or active autoimmune disorder requiring cytotoxic or immunosuppressive therapy, except for any of the following:

    • Presence of laboratory evidence of autoimmune disease (e.g., positive ANA titer) without symptoms
    • Clinical evidence of vitiligo or other forms of depigmenting illness
    • Mild arthritis requiring nonsteroidal anti-inflammatory medication
  • No autoimmune disorder with visceral involvement

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No recent (within the past year) or concurrent addiction to alcohol or illicit drugs
  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 4 weeks since prior sargramostim (GM-CSF), interferon alfa-2b, or interleukin-2
  • No prior vaccination with any of the study peptides

Chemotherapy

  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • 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
  • No concurrent corticosteroids
  • No concurrent topical or systemic steroids

Radiotherapy

  • See Disease Characteristics
  • No prior radiotherapy to measurable disease
  • At least 4 weeks since prior local control or palliative radiotherapy and recovered
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics
  • Recovered from prior major surgery
  • No concurrent surgery
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071981

Show 62 study locations  Show 62 Study Locations

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Craig L. Slingluff, MD     University of Virginia    
Investigator:     John M. Kirkwood, MD     UPMC Cancer Centers    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000335055, ECOG-E1602
First Received:   November 4, 2003
Last Updated:   August 28, 2008
ClinicalTrials.gov Identifier:   NCT00071981
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma  
recurrent melanoma  

Study placed in the following topic categories:
Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Freund's Adjuvant
Nevus
Recurrence
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Adjuvants, Immunologic
Nevi and Melanomas
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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