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CompletedNCT00071981Updated Jun 28, 2023Results posted

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

A Phase 2 interventional study of incomplete Freund's adjuvant and melanoma helper peptide vaccine in Melanoma (Skin), sponsored by Eastern Cooperative Oncology Group. Completed at 65 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-28.

Sponsored by Eastern Cooperative Oncology Group · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
175
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Melanoma (Skin)

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Keywords

  • stage IV melanoma
  • recurrent melanoma
03

In context

Melanoma

3,005 studies on the registry are indexed under Melanoma; 519 are open to participants now.

This study's enrollment of 175 is above the median of 38 across 2,350 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

Eastern Cooperative Oncology Group is the lead sponsor of 173 studies on the registry; 7 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
175 participants (actual)

Study arms

  • Experimental
    Arm I (12MP)

    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 (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.

    Biological: incomplete Freund's adjuvant · Biological: multi-epitope melanoma peptide vaccine · Biological: sargramostim

  • Experimental
    Arm II (12MP/Tet)

    Patients 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.

    Biological: incomplete Freund's adjuvant · Biological: multi-epitope melanoma peptide vaccine · Biological: sargramostim · Biological: tetanus peptide melanoma vaccine

  • Experimental
    Arm III (12MP/6MHP)

    Patients 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.

    Biological: incomplete Freund's adjuvant · Biological: melanoma helper peptide vaccine · Biological: multi-epitope melanoma peptide vaccine · Biological: sargramostim

  • Experimental
    Arm IV (6MHP)

    Patients 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.

    Biological: incomplete Freund's adjuvant · Biological: melanoma helper peptide vaccine · Biological: sargramostim

Interventions

  • Biologicalincomplete Freund's adjuvant

    Given by injection

    Also known as: Montanide ISA-51

  • Biologicalmelanoma helper peptide vaccine

    Given by injection

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

  • Biologicalmulti-epitope melanoma peptide vaccine

    Given by injection

    Also known as: 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

  • Biologicalsargramostim

    Given by injection

    Also known as: rhu GM-CSF,, Leukine,, Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)

  • Biologicaltetanus peptide melanoma vaccine

    Given by injection

    Also known as: Modified Tetanus p2 peptide restricted by class II MHC molecules,, Peptide-Tet

06

What researchers measure

Primary outcomes

  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.

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

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

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

07

Results

Posted Jan 3, 2013

Participant flow

This study was activated on March 21, 2005, accrued its first patient on May 9, 2005, and terminated on January 12, 2009 with the final accrual of 175 patients.22 ECOG institutions participated in the study.

Participant flow — Overall Study
MilestoneArm I (12MP)Arm II (12MP/Tet)Arm III (12MP/6MHP)Arm IV (6MHP)
Started47433748
Eligible43363342
Treated45383648
Eligible and treated41333242
Have ctl response data40302941
Have helper t cell response data37272539
Completed1203
Not completed46413745
Withdrew: Lack of efficacy37293043
Withdrew: Adverse event4431
Withdrew: Death0011
Withdrew: Withdrawal by subject3100
Withdrew: No protocol therapy2510
Withdrew: Others (not specified in the study)0220

Outcome measures

PrimaryCytotoxic 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.

Time frame:
Immune response was assessed at pre-registrtion, in weeks 1, 3, 5, 7, 8
Reported as:
Number · percentage of participants
Cytotoxic T-cell Lymphocytes (CTL) Response Rate
percentage of participantsArm I (12MP)Arm II (12MP/Tet)Arm III (12MP/6MHP)Arm IV (6MHP)
Cytotoxic T-cell Lymphocytes (CTL) Response Rate43 (27 to 59)47 (28 to 66)28 (13 to 47)5 (0.6 to 16.5)
Statistical analysis
  • Arm I (12MP) vs Arm II (12MP/Tet) vs Arm III (12MP/6MHP) vs Arm IV (6MHP) · Fisher Exact · p = <0.001
SecondaryHelper 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.

Time frame:
Immune response was assessed at pre-registration, in weeks 1,3,5,7,8
Reported as:
Number · percentage of participants
Helper T-cells Response to 6MHP
percentage of participantsArm I (12MP)Arm II (12MP/Tet)Arm III (12MP/6MHP)Arm IV (6MHP)
Helper T-cells Response to 6MHP3 (0 to 14)0 (0 to 13)40 (21 to 61)41 (26 to 58)
Statistical analysis
  • Arm I (12MP) vs Arm II (12MP/Tet) vs Arm III (12MP/6MHP) vs Arm IV (6MHP) · Fisher Exact · p = <0.001
SecondaryHelper 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.

Time frame:
Immune response was assessed at pre-registration, in weeks 1,3,5,7,8
Reported as:
Number · percentage of participants
Helper T Cell Response to Tetanus
percentage of participantsArm I (12MP)Arm II (12MP/Tet)Arm III (12MP/6MHP)Arm IV (6MHP)
Helper T Cell Response to Tetanus11 (3 to 25)59 (39 to 79)4 (0 to 20)0 (0 to 9)
Statistical analysis
  • Arm I (12MP) vs Arm II (12MP/Tet) vs Arm III (12MP/6MHP) vs Arm IV (6MHP) · Fisher Exact · p = <0.001
SecondaryObjective 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.

Time frame:
Tumor response was assessed in weeks 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 6 months after last vaccination
Reported as:
Number · percentage of participants
Objective Response Rate
percentage of participantsArm I (12MP)Arm II (12MP/Tet)Arm III (12MP/6MHP)Arm IV (6MHP)
Objective Response Rate2.4 (0.06 to 12.8)3.0 (0.08 to 15.8)6.3 (0.8 to 20.8)7.1 (1.5 to 19.5)
Statistical analysis
  • Arm I (12MP) vs Arm II (12MP/Tet) vs Arm III (12MP/6MHP) vs Arm IV (6MHP) · Fisher Exact · p = 0.741
SecondaryMedian Overall Survival (OS)

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

Time frame:
assessed every 3 month within 2 years and every 6 months betwen 2 and 5 years
Reported as:
Median · months
Median Overall Survival (OS)
monthsArm I (12MP)Arm II (12MP/Tet)Arm III (12MP/6MHP)Arm IV (6MHP)
Median Overall Survival (OS)14.9 (10.1 to 18.6)10.2 (6.7 to 12.2)12.4 (4.8 to 16.8)11.1 (8.8 to 14.2)
Statistical analysis
  • Arm I (12MP) vs Arm II (12MP/Tet) vs Arm III (12MP/6MHP) vs Arm IV (6MHP) · Log Rank · p = 0.532

Adverse events

Collected over Assessed at the end of each cycle while on treatment and at 30 days following the last dose of treatment. Reported every 3 months within 2 years of study entry, and every 6 months between 2-5 years of study entry. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm I (12MP)—6/45 (13.3%)36/45 (80%)
Arm II (12MP/Tet)—9/38 (23.7%)28/38 (73.7%)
Arm III (12MP/6MHP)—6/36 (16.7%)28/36 (77.8%)
Arm IV (6MHP)—4/48 (8.3%)33/48 (68.8%)
Most frequent serious events
Showing 10 of 25
Most frequent serious events
EventArm I (12MP)Arm II (12MP/Tet)Arm III (12MP/6MHP)Arm IV (6MHP)
FatigueGeneral disorders0/454/385/361/48
Injection site reactionGeneral disorders2/453/380/362/48
Alanine aminotransferase (ALT, SGPT)Investigations0/450/382/360/48
TinnitusEar and labyrinth disorders0/450/381/360/48
LymphopeniaInvestigations1/451/381/360/48
UlcerationSkin and subcutaneous tissue disorders0/451/381/360/48
NauseaGastrointestinal disorders0/450/381/360/48
VomitingGastrointestinal disorders0/450/381/360/48
Aspartate aminotransferase (AST, SGOT)Investigations0/450/381/360/48
Blood bilirubin increasedInvestigations0/450/381/360/48
Most frequent other events
Showing 10 of 28
Most frequent other events
EventArm I (12MP)Arm II (12MP/Tet)Arm III (12MP/6MHP)Arm IV (6MHP)
Injection site reactionGeneral disorders28/4520/3818/3618/48
FatigueGeneral disorders9/4511/3810/367/48
LymphopeniaInvestigations2/458/386/364/48
NauseaGastrointestinal disorders1/456/383/362/48
Rash/desquamationSkin and subcutaneous tissue disorders1/452/385/361/48
Metabolic/Laboratory-otherInvestigations2/452/385/363/48
Muscle, painMusculoskeletal and connective tissue disorders6/451/382/361/48
Leukopenia (Leukocytes decreased)Investigations3/455/381/360/48
Rigors/chillsGeneral disorders1/455/384/362/48
Aspartate aminotransferase increased (AST, SGOT)Investigations3/455/382/361/48

Baseline characteristics

Age, Continuous
Age, Continuous(years)Arm I (12MP)Arm II (12MP/Tet)Arm III (12MP/6MHP)Arm IV (6MHP)Total
Median65 (35 to 86)69 (31 to 88)66 (32 to 89)64 (40 to 82)66 (31 to 89)
Sex: Female, Male
Sex: Female, Male(Participants)Arm I (12MP)Arm II (12MP/Tet)Arm III (12MP/6MHP)Arm IV (6MHP)Total
Female1814111760
Male2319212588
Region of Enrollment
Region of Enrollment(participants)Arm I (12MP)Arm II (12MP/Tet)Arm III (12MP/6MHP)Arm IV (6MHP)Total
United States41333242148
08

Study locations

65 sites
  • Veterans Affairs Medical Center - Palo Alto
    Palo Alto, California 94304, United States
  • Stanford Cancer Center
    Stanford, California 94305-5824, United States
  • Tunnell Cancer Center at Beebe Medical Center
    Lewes, Delaware 19958, United States
  • CCOP - Christiana Care Health Services
    Newark, Delaware 19713, United States
  • Mayo Clinic - Jacksonville
    Jacksonville, Florida 32224, United States
  • University of Miami Sylvester Comprehensive Cancer Center - Miami
    Miami, Florida 33136, United States
  • Rush-Copley Cancer Care Center
    Aurora, Illinois 60504, United States
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
    Chicago, Illinois 60611-3013, United States
  • Hematology and Oncology Associates
    Chicago, Illinois 60611, United States
  • Midwest Center for Hematology/Oncology
    Joliet, Illinois 60432, United States
  • Joliet Oncology-Hematology Associates, Limited - West
    Joliet, Illinois 60435, United States
  • North Shore Oncology and Hematology Associates, Limited - Libertyville
    Libertyville, Illinois 60048, United States
  • Cancer Care and Hematology Specialists of Chicagoland - Niles
    Niles, Illinois 60714, United States
  • Hematology Oncology Associates - Skokie
    Skokie, Illinois 60076, United States
  • Carle Cancer Center at Carle Foundation Hospital
    Urbana, Illinois 61801, United States
  • CCOP - Carle Cancer Center
    Urbana, Illinois 61801, United States
  • Indiana University Melvin and Bren Simon Cancer Center
    Indianapolis, Indiana 46202-5289, United States
  • William N. Wishard Memorial Hospital
    Indianapolis, Indiana 46202, United States
  • Saint Anthony Memorial Health Centers
    Michigan City, Indiana 46360, United States
  • McCreery Cancer Center at Ottumwa Regional
    Ottumwa, Iowa 52501, United States
  • Greater Baltimore Medical Center Cancer Center
    Baltimore, Maryland 21204, United States
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    Baltimore, Maryland 21231-2410, United States
  • Union Hospital Cancer Program at Union Hospital
    Elkton, Maryland 21921, United States
  • Borgess Medical Center
    Kalamazoo, Michigan 49001, United States
  • West Michigan Cancer Center
    Kalamazoo, Michigan 49007-3731, United States
  • Bronson Methodist Hospital
    Kalamazoo, Michigan 49007, United States
  • Fairview Ridges Hospital
    Burnsville, Minnesota 55337, United States
  • Mercy and Unity Cancer Center at Mercy Hospital
    Coon Rapids, Minnesota 55433, United States
  • Fairview Southdale Hospital
    Edina, Minnesota 55435, United States
  • Mercy and Unity Cancer Center at Unity Hospital
    Fridley, Minnesota 55432, United States
  • Minnesota Oncology Hematology, PA - Maplewood
    Maplewood, Minnesota 55109, United States
  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
    Minneapolis, Minnesota 55407, United States
  • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
    Robbinsdale, Minnesota 55422-2900, United States
  • Mayo Clinic Cancer Center
    Rochester, Minnesota 55905, United States
  • CCOP - Metro-Minnesota
    Saint Louis Park, Minnesota 55416, United States
  • Park Nicollet Cancer Center
    Saint Louis Park, Minnesota 55416, United States
  • United Hospital
    Saint Paul, Minnesota 55102, United States
  • St. Francis Cancer Center at St. Francis Medical Center
    Shakopee, Minnesota 55379, United States
  • Ridgeview Medical Center
    Waconia, Minnesota 55387, United States
  • Minnesota Oncology Hematology, PA - Woodbury
    Woodbury, Minnesota 55125, United States
  • CCOP - Northern New Jersey
    Hackensack, New Jersey 07601, United States
  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
    New Brunswick, New Jersey 08903, United States
  • Cancer Institute of New Jersey at Cooper - Voorhees
    Voorhees, New Jersey 08043, United States
  • Christ Hospital Cancer Center
    Cincinnati, Ohio 45219, United States
  • Case Comprehensive Cancer Center
    Cleveland, Ohio 44106-5065, United States
  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
    Allentown, Pennsylvania 18105, United States
  • St. Mary Regional Cancer Center
    Langhorne, Pennsylvania 19047, United States
  • Fox Chase Cancer Center - Philadelphia
    Philadelphia, Pennsylvania 19111-2497, United States
  • UPMC Cancer Centers
    Pittsburgh, Pennsylvania 15232, United States
  • Avera Cancer Institute
    Sioux Falls, South Dakota 57105, United States
  • Medical X-Ray Center, PC
    Sioux Falls, South Dakota 57105, United States
  • Sanford Cancer Center at Sanford USD Medical Center
    Sioux Falls, South Dakota 57117-5039, United States
  • Center for Cancer Treatment & Prevention at Sacred Heart Hospital
    Eau Claire, Wisconsin 54701, United States
  • Marshfield Clinic Cancer Care at Regional Cancer Center
    Eau Claire, Wisconsin 54701, United States
  • Gundersen Lutheran Center for Cancer and Blood
    La Crosse, Wisconsin 54601, United States
  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
    Madison, Wisconsin 53792-6164, United States
  • Marshfield Clinic - Marshfield Center
    Marshfield, Wisconsin 54449, United States
  • Saint Joseph's Hospital
    Marshfield, Wisconsin 54449, United States
  • Marshfield Clinic - Lakeland Center
    Minocqua, Wisconsin 54548, United States
  • Ministry Medical Group at Saint Mary's Hospital
    Rhinelander, Wisconsin 54501, United States
  • Marshfield Clinic - Indianhead Center
    Rice Lake, Wisconsin 54868, United States
  • Saint Michael's Hospital Cancer Center
    Stevens Point, Wisconsin 54481, United States
  • Marshfield Clinic - Wausau Center
    Wausau, Wisconsin 54401, United States
  • Marshfield Clinic - Weston Center
    Weston, Wisconsin 54476, United States
  • Marshfield Clinic - Wisconsin Rapids Center
    Wisconsin Rapids, Wisconsin 54494, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00071981
Lead sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Nov 6, 2003
Start date
May 9, 2005
Primary completion
Aug 2011
Completion
Jan 2014
Results posted
Jan 3, 2013
Last update
Jun 28, 2023

Study contacts

Craig L. Slingluff, MD
study chair · University of Virginia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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