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Melanoma (Skin)Phase 2NCT00071981

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

A Phase 2 study testing incomplete Freund's adjuvant, melanoma helper peptide vaccine and multi-epitope melanoma peptide vaccine in people with Melanoma (Skin), run by Eastern Cooperative Oncology Group at 65 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma (Skin)
What is being tested?
incomplete Freund's adjuvant, melanoma helper peptide vaccine and multi-epitope melanoma peptide vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
175 participants
Where
65 sitesUnited States
Study dates
9 May 2005to Jan 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • More than 3 brain metastases
  • Metastatic lesions greater than 2 cm
  • Concurrent radiotherapy
  • Prior radiotherapy to measurable disease
  • Concurrent surgery
  • Concurrent corticosteroids
Show all 19Show fewer
  • 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

Trial locations and contacts

65 sites in 1 country.

65 sites in 1 country

United States65 sites

  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18105

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60504

  • Greater Baltimore Medical Center Cancer Center

    Baltimore, Maryland, 21204

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • Hematology and Oncology Associates

    Chicago, Illinois, 60611

  • Christ Hospital Cancer Center

    Cincinnati, Ohio, 45219

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Center for Cancer Treatment & Prevention at Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

  • Marshfield Clinic Cancer Care at Regional Cancer Center

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Union Hospital Cancer Program at Union Hospital

    Elkton, Maryland, 21921

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • CCOP - Northern New Jersey

    Hackensack, New Jersey, 07601

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202-5289

  • William N. Wishard Memorial Hospital

    Indianapolis, Indiana, 46202

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Midwest Center for Hematology/Oncology

    Joliet, Illinois, 60432

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Gundersen Lutheran Center for Cancer and Blood

    La Crosse, Wisconsin, 54601

  • St. Mary Regional Cancer Center

    Langhorne, Pennsylvania, 19047

  • Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, 19958

  • North Shore Oncology and Hematology Associates, Limited - Libertyville

    Libertyville, Illinois, 60048

  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • Minnesota Oncology Hematology, PA - Maplewood

    Maplewood, Minnesota, 55109

  • Marshfield Clinic - Marshfield Center

    Marshfield, Wisconsin, 54449

  • Saint Joseph's Hospital

    Marshfield, Wisconsin, 54449

  • University of Miami Sylvester Comprehensive Cancer Center - Miami

    Miami, Florida, 33136

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Marshfield Clinic - Lakeland Center

    Minocqua, Wisconsin, 54548

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

    New Brunswick, New Jersey, 08903

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Cancer Care and Hematology Specialists of Chicagoland - Niles

    Niles, Illinois, 60714

  • McCreery Cancer Center at Ottumwa Regional

    Ottumwa, Iowa, 52501

  • Veterans Affairs Medical Center - Palo Alto

    Palo Alto, California, 94304

  • Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, 19111-2497

  • UPMC Cancer Centers

    Pittsburgh, Pennsylvania, 15232

  • Ministry Medical Group at Saint Mary's Hospital

    Rhinelander, Wisconsin, 54501

  • Marshfield Clinic - Indianhead Center

    Rice Lake, Wisconsin, 54868

  • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

    Robbinsdale, Minnesota, 55422-2900

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Cancer Center

    Saint Louis Park, Minnesota, 55416

  • United Hospital

    Saint Paul, Minnesota, 55102

  • St. Francis Cancer Center at St. Francis Medical Center

    Shakopee, Minnesota, 55379

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Medical X-Ray Center, PC

    Sioux Falls, South Dakota, 57105

  • Sanford Cancer Center at Sanford USD Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • Hematology Oncology Associates - Skokie

    Skokie, Illinois, 60076

  • Stanford Cancer Center

    Stanford, California, 94305-5824

  • Saint Michael's Hospital Cancer Center

    Stevens Point, Wisconsin, 54481

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois, 61801

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Marshfield Clinic - Wausau Center

    Wausau, Wisconsin, 54401

  • Marshfield Clinic - Weston Center

    Weston, Wisconsin, 54476

  • Marshfield Clinic - Wisconsin Rapids Center

    Wisconsin Rapids, Wisconsin, 54494

  • Minnesota Oncology Hematology, PA - Woodbury

    Woodbury, Minnesota, 55125

Other trials in United States

About this study

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

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.

Read the 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 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 Major histocompatibility complex (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 (Granulocyte-macrophage colony-stimulating factor, 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.

ACTUAL ACCRUAL: A total of 175 patients were accrued for this study during March 2005 and January 2009.

Conditions
Melanoma (Skin)
Being tested
incomplete Freund's adjuvant, melanoma helper peptide vaccine, multi-epitope melanoma peptide vaccine, sargramostim, tetanus peptide melanoma vaccine
Keywords
stage IV melanoma, recurrent melanoma
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • incomplete Freund's adjuvantBiological

    Also called Montanide ISA-51

    Given by injection

  • melanoma helper peptide vaccineBiological

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

    Given by injection

  • multi-epitope melanoma peptide vaccineBiological

    Also called 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

    Given by injection

  • sargramostimBiological

    Also called rhu GM-CSF,, Leukine,, Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)

    Given by injection

  • tetanus peptide melanoma vaccineBiological

    Also called Modified Tetanus p2 peptide restricted by class II MHC molecules,, Peptide-Tet

    Given by injection

Study groups in NCT00071981
Study groupRoleWhat they receive
Arm I (12MP)ExperimentalPatients 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.
Receives: Biological: incomplete Freund's adjuvant; Biological: multi-epitope melanoma peptide vaccine; Biological: sargramostim
Arm II (12MP/Tet)ExperimentalPatients 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.
Receives: Biological: incomplete Freund's adjuvant; Biological: multi-epitope melanoma peptide vaccine; Biological: sargramostim; Biological: tetanus peptide melanoma vaccine
Arm III (12MP/6MHP)ExperimentalPatients 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.
Receives: Biological: incomplete Freund's adjuvant; Biological: melanoma helper peptide vaccine; Biological: multi-epitope melanoma peptide vaccine; Biological: sargramostim
Arm IV (6MHP)ExperimentalPatients 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.
Receives: Biological: incomplete Freund's adjuvant; Biological: melanoma helper peptide vaccine; Biological: sargramostim

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)

  1. Helper T-cells Response to 6MHP

    Helper T cell response was evaluated by tritiated thymidine proliferation assay with fresh/cryopreserved PBL in the presence of each of the helper peptides.

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

  2. Helper T Cell Response to Tetanus

    Helper T cell response was evaluated by tritiated thymidine proliferation assay with fresh/cryopreserved PBL in the presence of each of the helper peptides.

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

  3. Objective Response Rate

    Tumor response was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Objective response rate is calculated as the number of patients with complete response (disappearance of all lesions) or partial response () divided by total number of evaluable patients.

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

  4. Median Overall Survival (OS)

    OS was defined as the time from registration to death from any cause.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2003 (estimated)
  2. Study start9 May 2005
  3. Primary completionAug 2011
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00071981
Sponsor's protocol ID
CDR0000335055
Other IDs
U10CA021115, E1602
Status last verified
Jun 2023
First submitted
4 Nov 2003
Last updated
28 Jun 2023
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing incomplete Freund's adjuvant, melanoma helper peptide vaccine and multi-epitope melanoma peptide vaccine in people with Melanoma (Skin), run by Eastern Cooperative Oncology Group at 65 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 35 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cytotoxic T-cell Lymphocytes (CTL) Response Rate (time frame: Immune response was assessed at pre-registrtion, in weeks 1, 3, 5, 7, 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00071981.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.

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