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



Status:Completed
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2005
End Date:January 2014

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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.

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.

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
We found this trial at
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220 North 24th St S
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Marshfield Clinic - Wisconsin Rapids Center Marshfield Clinic Wisconsin Rapids Center offers services in family...
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
(610) 402-8000
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Lehigh Valley Hospital provides a...
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Baltimore, Maryland 21231
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
2302
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675 N Saint Clair St # 21-100
Chicago, Illinois 60611
(312) 695-1156
Robert H. Lurie Comprehensive Cancer Center at Northwestern University The cancer center was first established...
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Chicago, IL
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106 Bow Street
Elkton MD, Maryland 21921
2341
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Elkton MD, MD
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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
1837
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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1900 South Avenue
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902 Savannah Road
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3900 W Avera Drive
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42 E Laurel Rd # 2545
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Aurora, Illinois 60507
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6701 North Charles Street
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Cincinnati, Ohio 45219
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11100 Euclid Avenue
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11850 Blackfoot St. NW Suite 130
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6401 France Ave S
Edina, Minnesota 55435
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Hackensack, New Jersey 07601
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Indianapolis, Indiana 46202
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535 Barnhill Dr
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Joliet, IL
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1521 Gull Rd
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Langhorne, Pennsylvania 19047
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1800 Hollister Drive, Suite 112
Libertyville, Illinois 60048
847-367-6781
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1654
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Madison, WI
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Maplewood, Minnesota 55109
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1000 N Oak Ave
Marshfield, Wisconsin 54449
(715) 387-5511
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611 Saint Joseph Avenue
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301 W Homer St
Michigan City, Indiana 46360
(219) 879-8511
Saint Anthony Memorial Health Centers Franciscan St. Anthony Health - Michigan City is proud to...
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800 E 28th St
Minneapolis, Minnesota 55407
612-863-4000
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195 Little Albany St
New Brunswick, New Jersey 08903
(732) 235-2465
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4701 Ogletown-Stanton Road
Newark, Delaware 19713
302-623-4450
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8915 W Golf Rd
Niles, Illinois 60714
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1001 PENNSYLVANIA AVENUE
Ottumwa, Iowa 52501
641.684.2300
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Palo Alto, California 94304
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Philadelphia, Pennsylvania 19111
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Pittsburgh, Pennsylvania 15232
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2251 North Shore Drive
Rhinelander, Wisconsin 54501
715.361.2000
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Rice Lake, Wisconsin 54868
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Rice Lake, WI
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1507
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
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3931 Louisiana Ave S
Saint Louis Park, Minnesota 55426
(952) 993-3248
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333 Smith Ave
Saint Paul, Minnesota 55102
(651) 241-8000
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1455 St. Francis Ave.
Shakopee, Minnesota 55379
952.428.2031
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Sioux Falls, South Dakota 57117
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Skokie, IL
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Stanford, California 94305
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Stanford, CA
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Stevens Point, Wisconsin 54481
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Stevens Point, WI
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1685
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Urbana, IL
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509 W. University Avenue
Urbana, Illinois 61801
(217) 383-3516
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Urbana, IL
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500 S Maple Street
Waconia, Minnesota 55387
952-442-2191
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Waconia, MN
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2727 Plaza Dr
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(715) 847-3000
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1675
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3501 Cranberry Blvd
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1522
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Woodbury, MN
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