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Last Modified: 1/7/2009     First Published: 10/24/2003  
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Phase II Randomized Study of Multi-Epitope Vaccination With Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Patients With Metastatic Melanoma

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase
 Type
 Status
 Age
 Sponsor
 Protocol IDs

Phase II
Treatment
Active
18 and over
NCI
ECOG-E1602
NCT00071981, E1602

Objectives

  1. 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.
  2. Compare the helper T-cell response to each of 6 melanoma helper peptides restricted by HLA-DR molecules in patients treated with these vaccinations.
  3. 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.
  4. Determine, preliminarily, whether booster vaccination maintains immune response in patients treated with these vaccinations.
  5. Compare the rates of clinical response and survival in patients treated with these vaccinations.
  6. Determine, preliminarily, whether cellular immune response correlates with clinical response and survival rates in patients treated with these vaccinations.

Entry 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


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

Patient Characteristics:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • WBC at least 4,000/mm3
  • Platelet count at least 100,000/mm3
  • Lymphocyte count at least 700/mm3

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

Expected Enrollment

169

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

Outcomes

Primary Outcome(s)

Immune response as measured by amount of peripheral blood T-cell lymphocytes present over the first 6 weeks

Secondary Outcome(s)

Clinical response as measured by amount of helper T-cells present at week 8

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 (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.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Craig Slingluff, MD, Protocol chair
Ph: 434-243-2611; 800-223-9173
Email: cls8h@virginia.edu
John Kirkwood, MD, Protocol co-chair
Ph: 412-692-4724

Trial Sites

U.S.A.
California
  Palo Alto
 Veterans Affairs Medical Center - Palo Alto
 Harlan Pinto, MD
Ph: 650-725-9057
  Stanford
 Stanford Cancer Center
 Clinical Trials Office - Stanford Cancer Center
Ph: 650-498-7061
 Email: cctoffice@stanford.edu
Connecticut
  Manchester
 Manchester Memorial Hospital
 Jeffrey Wasser, MD
Ph: 860-533-4000
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Clinical Trials Office - Tunnell Cancer Center
Ph: 302-645-3171
  Newark
 CCOP - Christiana Care Health Services
 Clinical Trial Office - CCOP - Christiana Care Health Services
Ph: 302-733-6227
Florida
  Jacksonville
 Baptist Cancer Institute - Jacksonville
 Clinical Trials Office - Baptist Cancer Institute - Jacksonville
Ph: 904-202-7051
 Mayo Clinic - Jacksonville
 Clinical Trials Office - All Mayo Clinic Locations
Ph: 507-538-7623
  Miami
 University of Miami Sylvester Comprehensive Cancer Center - Miami
 University of Miami Sylvester Comprehensive Cancer Center Clinical Trial Matching Service
Ph: 866-574-5124
 Email: Sylvester@emergingmed.com
Illinois
  Aurora
 Rush-Copley Cancer Care Center
 Kendrith Rowland, MD
Ph: 217-383-3019
  Chicago
 Hematology and Oncology Associates
 Clinical Trails Office - Hematology and Oncology Associates
Ph: 312-695-1301
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Clinical Trials Office - Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Ph: 312-695-1301
 Email: cancer@northwestern.edu
  Joliet
 Joliet Oncology-Hematology Associates, Limited - West
 Kendrith Rowland, MD
Ph: 217-383-3019
 Midwest Center for Hematology/Oncology
 Timothy Kuzel, MD
Ph: 312-695-6180
  Libertyville
 North Shore Oncology and Hematology Associates, Limited - Libertyville
 Timothy Kuzel, MD
Ph: 312-695-6180
  Niles
 Cancer Care and Hematology Specialists of Chicagoland - Niles
 Timothy Kuzel, MD
Ph: 312-695-6180
  Skokie
 Hematology Oncology Associates - Skokie
 Timothy Kuzel, MD
Ph: 312-695-6180
  Urbana
 Carle Cancer Center at Carle Foundation Hospital
 Clinical Trials Office - Carle Cancer Center
Ph: 800-446-5532
 CCOP - Carle Cancer Center
 Clinical Trials Office - CCOP - Carle Cancer Center
Ph: 800-446-5532
Indiana
  Indianapolis
 Indiana University Melvin and Bren Simon Cancer Center
 Clinical Trials Office - Indiana University Cancer Center
Ph: 317-274-2552
 William N. Wishard Memorial Hospital
 Theodore Logan, MD
Ph: 317-278-7576
  Michigan City
 Saint Anthony Memorial Health Centers
 Kendrith Rowland, MD
Ph: 217-383-3019
Iowa
  Ottumwa
 McCreery Cancer Center at Ottumwa Regional
 Roscoe Morton, MD, FACP
Ph: 515-282-2921
Louisiana
  Baton Rouge
 Ochsner Health Center - Bluebonnet
 Carl Kardinal, MD
Ph: 504-842-3910
  Covington
 Ochsner Health Center - Covington
 Carl Kardinal, MD
Ph: 504-842-3910
  New Orleans
 Ochsner Cancer Institute at Ochsner Clinic Foundation
 Carl Kardinal, MD
Ph: 504-842-3910
Maryland
  Baltimore
 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Ph: 410-955-8804
 Email: jhcccro@jhmi.edu
  Elkton MD
 Union Hospital Cancer Program at Union Hospital
 Gregory Masters, MD
Ph: 302-366-1200
Michigan
  Kalamazoo
 Borgess Medical Center
 Raymond Lord, MD
Ph: 269-373-7458
 Bronson Methodist Hospital
 Raymond Lord, MD
Ph: 269-373-7458
 West Michigan Cancer Center
 Clinical Trials Office - West Michigan Cancer Center
Ph: 269-373-7458
Minnesota
  Burnsville
 Fairview Ridges Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Edina
 Fairview Southdale Hospital
 Clinical Trials Office - Fairview Southdale Hospital
Ph: 612-625-3650
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Maplewood
 Minnesota Oncology Hematology, PA - Maplewood
 Patrick Flynn, MD
Ph: 612-863-8585
  Minneapolis
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Clinical Trials Office - Virginia Piper Cancer Institute
Ph: 612-863-5654
  Robbinsdale
 Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
 Clinical Trials Office - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Ph: 763-520-1893
  Rochester
 Mayo Clinic Cancer Center
 Clinical Trials Office - All Mayo Clinic Locations
Ph: 507-538-7623
  Saint Louis Park
 CCOP - Metro-Minnesota
 Patrick Flynn, MD
Ph: 612-863-8585
 Park Nicollet Cancer Center
 Patrick Flynn, MD
Ph: 612-863-8585
  Saint Paul
 United Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Shakopee
 St. Francis Cancer Center at St. Francis Medical Center
 Patrick Flynn, MD
Ph: 612-863-8585
  Waconia
 Ridgeview Medical Center
 Patrick Flynn, MD
Ph: 612-863-8585
  Woodbury
 Minnesota Oncology Hematology, PA - Woodbury
 Patrick Flynn, MD
Ph: 612-863-8585
Mississippi
  Hattiesburg
 Hattiesburg Clinic, PA at Forrest General
 Carl Kardinal, MD
Ph: 504-842-3910
 Hematology & Oncology Clinic
 Carl Kardinal, MD
Ph: 504-842-3910
New Jersey
  Hackensack
 CCOP - Northern New Jersey
 David Siegel
Ph: 201-996-5834
  New Brunswick
 Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
 Clinical Trials Office - Cancer Institute of New Jersey
Ph: 732-235-8675
  Red Bank
 Booker Cancer Center at Riverview Medical Center
 Denis Fitzgerald, MD
Ph: 732-530-8666
  Voorhees
 Cancer Institute of New Jersey at Cooper - Voorhees
 Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees
Ph: 856-325-6757
Ohio
  Cincinnati
 Christ Hospital Cancer Center
 Philip Leming, MD
Ph: 513-321-4333
  Cleveland
 Case Comprehensive Cancer Center
 Clinical Trials Office - Case Comprehensive Cancer Center
Ph: 800-641-2422
 MetroHealth Cancer Care Center at MetroHealth Medical Center
 Bruce Averbook, MD, FACS
Ph: 216-778-4795
  Lima
 St. Rita's Medical Center
 Clinical Trials Office - St. Rita's Medical Center
Ph: 419-226-9617
Pennsylvania
  Allentown
 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
 Eliot Friedman, MD
Ph: 610-402-0512
  Langhorne
 St. Mary Regional Cancer Center
 Clinical Trials Office - St. Mary Regional Cancer Center
Ph: 215-710-4585
  Philadelphia
 Fox Chase Cancer Center - Philadelphia
 Clinical Trials Office - Fox Chase Cancer Center - Philadelphia
Ph: 215-728-4790
  Pittsburgh
 UPMC Cancer Centers
 Clinical Trials Office - UPMC Cancer Centers
Ph: 412-647-8073
South Dakota
  Sioux Falls
 Avera Cancer Institute
 Loren Tschetter, MD
Ph: 605-328-8000
 Medical X-Ray Center, PC
 Loren Tschetter, MD
Ph: 605-328-8000
 Sanford Cancer Center at Sanford USD Medical Center
 Clinical Trials Office - Sanford Cancer Center
Ph: 605-328-1367
Wisconsin
  Eau Claire
 Center for Cancer Treatment & Prevention at Sacred Heart Hospital
 Seth Fagbemi, MD
Ph: 715-387-5426
 Marshfield Clinic Cancer Care at Regional Cancer Center
 Seth Fagbemi, MD
Ph: 715-387-5426
  La Crosse
 Gundersen Lutheran Center for Cancer and Blood
 Clinical Trials Office - Gundersen Lutheran Cancer Center
Ph: 608-775-2385
 Email: cancerctr@gundluth.org
  Madison
 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
 Clinical Trials Office - University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Ph: 608-262-5223
  Marshfield
 Marshfield Clinic - Marshfield Center
 Clinical Trials Office - Marshfield Clinic - Marshfield Center
Ph: 800-782-1581 ext. 94457
 Saint Joseph's Hospital
 Seth Fagbemi, MD
Ph: 715-387-5426
  Minocqua
 Marshfield Clinic - Lakeland Center
 Seth Fagbemi, MD
Ph: 715-387-5426
  Rhinelander
 Ministry Medical Group at Saint Mary's Hospital
 Seth Fagbemi, MD
Ph: 715-387-5426
  Rice Lake
 Marshfield Clinic - Indianhead Center
 Seth Fagbemi, MD
Ph: 715-387-5426
  Stevens Point
 Saint Michael's Hospital Cancer Center
 Seth Fagbemi, MD
Ph: 715-387-5426
  Wausau
 Marshfield Clinic - Wausau Center
 Seth Fagbemi, MD
Ph: 715-387-5426
  Weston
 Marshfield Clinic - Weston Center
 Seth Fagbemi, MD
Ph: 715-387-5426
  Wisconsin Rapids
 Marshfield Clinic - Wisconsin Rapids Center
 Seth Fagbemi, MD
Ph: 715-387-5426

Registry Information
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
Trial Start Date 2005-03-21
Trial Completion Date 2009-12-31 (estimated)
Registered in ClinicalTrials.gov NCT00071981
Date Submitted to PDQ 2003-09-11
Information Last Verified 2009-01-07
NCI Grant/Contract Number CA21115

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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