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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01989572
Other study ID # NCI-2013-02101
Secondary ID NCI-2013-02101CA
Status Completed
Phase Phase 3
First received
Last updated
Start date February 23, 2000
Est. completion date January 31, 2013

Study information

Verified date June 2020
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized phase III trial studies sargramostim or vaccine therapy alone to see how well they work compared to sargramostim and vaccine therapy together in preventing disease recurrence in patients with melanoma that has been removed by surgery. Sargramostim may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known whether yeast derived sargramostim and vaccine therapy are more effective alone or together in preventing recurrence of melanoma.


Description:

PRIMARY OBJECTIVES:

I. To compare overall survival and disease-free survival of patients with completely resected stage IV melanoma or stage III melanoma with gross extranodal extension, satellites, and/or intransit lesions, treated with granulocyte macrophage colony-stimulating factor (GM-CSF) (sargramostim) vs. no GM-CSF, or other high risk patients listed in the eligibility section.

SECONDARY OBJECTIVES:

I. To compare, using a 2 x 2 factorial design, overall survival and disease-free survival of human leukocyte antigen (HLA)-A2 positive patients treated with peptide vaccination vs. no peptide vaccination.

II. The following descriptive evaluations of survival and disease-free survival are planned for the HLA-A2 positive patients: (1) GM-CSF plus peptide vaccination vs. peptide vaccination alone; (2) GM-CSF plus peptide vaccination vs. GM-CSF alone; (3) GM-CSF plus peptide vaccination vs. placebo.

III. Survival and disease-free survival of HLA-A2 positive patients not receiving peptide vaccination will be compared to that of HLA-A2 negative patients not receiving peptide vaccination.

IV. To determine the influence of GM-CSF on circulating dendritic cell numbers and subpopulations in peripheral blood of patients receiving and not receiving GM-CSF.

V. To determine, in HLA-A2 positive patients, whether immunization with peptides with or without GM-CSF elicits a measurable T-cell response as assessed by enzyme-linked immunosorbent spot (ELISPOT) and the major histocompatibility complex (MHC) tetramer assay, and to determine the functionality of these cells by intracellular cytokine staining.

OUTLINE: HLA-A2 positive patients are randomized to 1 of 4 treatment regimens (Arms I-IV). HLA-A2 negative patients are randomized to 1 of 2 treatment arms (Arms V-VI).

ARM I: Patients receive sargramostim subcutaneously (SC) on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

ARM II: Patients receive sargramostim placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

ARM III: Patients receive sargramostim SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

ARM IV: Patients receive sargramostim placebo SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

ARM V: Patients receive sargramostim SC on days 1-14.

ARM VI: Patients receive sargramostim placebo SC on days 1-14.

In all arms, treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

In the event of recurrence, patients who undergo complete resection of the recurrence may continue treatment for 6 courses or until completion of 1 year of therapy (whichever is longer). For patients with recurrence that is not surgically resectable or experiencing second recurrence, treatment will be discontinued.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then every 12 months for 10 years.


Other known NCT identifiers
  • NCT00005034

Recruitment information / eligibility

Status Completed
Enrollment 815
Est. completion date January 31, 2013
Est. primary completion date October 8, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients must have HLA-A2 status known prior to randomization; typing may be obtained through a local laboratory facility or through a reference lab utilized by the initiating institution; if typing is not available through these means, it may be obtained from the University of Pittsburgh

- All patients must have disease completely resected with one of the following in order to be eligible:

- Completely resected disease

- Any locoregional recurrence after prior adjuvant interferon or failure on S008

- Any local recurrence of disease after adequate surgical excision of the original primary

- Mucosal melanoma

- Stage IV melanoma (cutaneous, ocular, mucosal, or unknown primary)

- The following groups of patients may be entered onto this trial only if they are ineligible for S0008 or are, in the opinion of the managing physician, medically unfit to receive standard high-dose interferon:

- Any clinically evident satellite or in-transit disease

- Stage II disease with gross extracapsular extension

- Recurrence in a previously resected nodal basin

- Four or more involved lymph nodes or matted lymph nodes

- Ulcerated primary melanoma and any involved lymph nodes

- NOTE: Patients who are eligible for S0008 will be strongly encouraged to participate in that study in preference to this one

- Patients must have been surgically rendered free of disease with negative margins on resected specimens; patients rendered free of disease by non-surgical means are not eligible

- Patients must be randomized within 112 days (16 weeks) of surgical resection; if more than one surgical procedure is required to render the patient disease-free, all required surgeries must be accomplished within this 16 week time period

- Patients must not have received any adjuvant treatment (chemotherapy, biotherapy, or limb perfusion) after the resection(s) that make(s) them eligible for this trial; one systemic treatment after a prior surgery is allowed, and must have been completed >= 8 weeks prior to randomization; (when chemotherapy and biotherapy are given together as one planned treatment [biochemotherapy], this counts as one regimen); NOTE: Previous radiation therapy, including after the resection, is allowed as long as 30 days elapse between the radiation and initiation of therapy

- Prior treatment with GM-CSF or any peptides used in this protocol, is not allowed

- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

- Patients must not have an active infection requiring treatment with parenteral antibiotics

- Patients must not have other significant medical, surgical, or psychiatric conditions or require any medication or treatment that may interfere with compliance on any of the E4697 treatment regimens

- Patients must not have a diagnosis or evidence of organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that might preclude participation in the full protocol

- Patients must be able to self-administer or arrange for administration of subcutaneous injections

- Patients who have other current malignancies are not eligible

- Patients with prior history at any time of any in situ cancer, lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ are eligible; patients who meet this criteria must be disease-free at time of randomization

- Patients with prior history of basal or squamous skin cancer are eligible; patients who meet this criteria must be disease-free at time of randomization

- Patients who have had multiple primary melanomas are eligible

- Patients with other malignancies are eligible if they have been continuously disease free for > 5 years prior to the time of randomization

- Patients must not have autoimmune disorders, conditions of immunosuppression or treatment with systemic corticosteroids, including oral steroids (i.e., prednisone, dexamethasone), continuous use of topical steroid creams or ointments, or any steroid containing inhalers; replacement doses of steroids for patients with adrenal insufficiency are allowed; patients who discontinue use of these classes of medication for at least 2 weeks prior to randomization are eligible if, in the judgment of the treating physician, the patient is not likely to require these classes of drugs during the study

- Women of childbearing potential must not be pregnant (negative beta human chorionic gonadotropin [bHCG] within 2 weeks prior to randomization) or breast-feeding

- Women of childbearing potential and sexually active males must be counseled to use an accepted and effective method of contraception (including abstinence) while on treatment and for a period of 18 months after completing or discontinuing treatment

- All patients must have brain computed tomography (CT) or magnetic resonance imaging (MRI), chest CT or chest x-ray (CXR), and abdominal (liver) CT or MRI within 4 weeks prior to randomization; positron emission tomography (PET) scans are also acceptable in place of CT, CXR and/or abdominal MRI if obtained within 4 weeks prior to randomization; patients with lesions on the lower extremity must also have pelvic imaging within this time period; this is also strongly recommended for patients with lesions on the lower trunk; PET scans are acceptable

- Patients with resection of visceral disease must have imaging of the affected area/organ documenting disease-free status within 2 weeks prior to randomization

- White blood cells (WBC) >= 3,000/mm?

- Platelet count >= 100,000/mm?

- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2 x institutional upper limit (IUL) of normal

- Bilirubin =< 2 x IUL of normal

- Serum creatinine =< 1.8 mg/dl

- Alkaline phosphatase and lactate dehydrogenase (LDH) must be performed within 4 weeks prior to randomization; LDH must be normal; patients with abnormal alkaline phosphatase which is =< 1.25 times the institutional upper limit of normal who have a negative CT or MRI of the liver and negative bone scan or a negative PET scan are eligible

- Patients with bone pain must have a bone scan within 4 weeks prior to randomization to document the absence of tumor

Study Design


Related Conditions & MeSH terms

  • Iris Melanoma
  • Medium/Large Size Posterior Uveal Melanoma
  • Melanoma
  • Mucosal Melanoma
  • Ocular Melanoma With Extraocular Extension
  • Recurrent Melanoma
  • Recurrent Uveal Melanoma
  • Skin Neoplasms
  • Small Size Posterior Uveal Melanoma
  • Stage IIA Cutaneous Melanoma AJCC v6 and v7
  • Stage IIA Uveal Melanoma AJCC v7
  • Stage IIB Cutaneous Melanoma AJCC v6 and v7
  • Stage IIB Uveal Melanoma AJCC v7
  • Stage IIC Cutaneous Melanoma AJCC v6 and v7
  • Stage IIIA Cutaneous Melanoma AJCC v7
  • Stage IIIA Uveal Melanoma AJCC v7
  • Stage IIIB Cutaneous Melanoma AJCC v7
  • Stage IIIB Uveal Melanoma AJCC v7
  • Stage IIIC Cutaneous Melanoma AJCC v7
  • Stage IIIC Uveal Melanoma AJCC v7
  • Stage IV Cutaneous Melanoma AJCC v6 and v7
  • Stage IV Uveal Melanoma AJCC v7
  • Uveal Neoplasms

Intervention

Other:
Laboratory Biomarker Analysis
Correlative studies
Placebo
Given GM-CSF placebo SC
Placebo
Given peptide placebo SC
Biological:
Sargramostim
Given SC
Tyrosinase Peptide
Given SC

Locations

Country Name City State
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States McFarland Clinic PC - Ames Ames Iowa
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Anne Arundel Medical Center Annapolis Maryland
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia
United States Augusta University Medical Center Augusta Georgia
United States Rush - Copley Medical Center Aurora Illinois
United States The Medical Center of Aurora Aurora Colorado
United States Greater Baltimore Medical Center Baltimore Maryland
United States Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland
United States Sinai Hospital of Baltimore Baltimore Maryland
United States Eastern Maine Medical Center Bangor Maine
United States Ochsner Health Center-Summa Baton Rouge Louisiana
United States Alta Bates Summit Medical Center-Herrick Campus Berkeley California
United States Saint Luke's University Hospital-Bethlehem Campus Bethlehem Pennsylvania
United States Montana Cancer Consortium NCORP Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Mid Dakota Clinic Bismarck North Dakota
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Saint Luke's Mountain States Tumor Institute Boise Idaho
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Cancer Center Boston Massachusetts
United States Tufts Medical Center Boston Massachusetts
United States Boulder Community Hospital Boulder Colorado
United States Montefiore Medical Center-Wakefield Campus Bronx New York
United States University of Vermont and State Agricultural College Burlington Vermont
United States Aultman Health Foundation Canton Ohio
United States Medical University of South Carolina Charleston South Carolina
United States West Virginia University Charleston Division Charleston West Virginia
United States Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina
United States Novant Health Presbyterian Medical Center Charlotte North Carolina
United States Northwestern University Chicago Illinois
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States University of Cincinnati/Barrett Cancer Center Cincinnati Ohio
United States Case Western Reserve University Cleveland Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States MetroHealth Medical Center Cleveland Ohio
United States University of Missouri - Ellis Fischel Columbia Missouri
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Medical City Dallas Hospital Dallas Texas
United States Geisinger Medical Center Danville Pennsylvania
United States Genesis Medical Center - East Campus Davenport Iowa
United States Dayton NCI Community Oncology Research Program Dayton Ohio
United States Atlanta VA Medical Center Decatur Georgia
United States SCL Health Saint Joseph Hospital Denver Colorado
United States Iowa Methodist Medical Center Des Moines Iowa
United States Iowa-Wide Oncology Research Coalition NCORP Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Delaware County Memorial Hospital Drexel Hill Pennsylvania
United States City of Hope Comprehensive Cancer Center Duarte California
United States Duke University Medical Center Durham North Carolina
United States Veterans Adminstration New Jersey Health Care System East Orange New Jersey
United States Swedish Medical Center Englewood Colorado
United States Eisenhower Army Medical Center Fort Gordon Georgia
United States Southwest Florida Regional Medical Center Fort Myers Florida
United States Aurora Cancer Care-Glendale Glendale Wisconsin
United States Glens Falls Hospital Glens Falls New York
United States Wayne Memorial Hospital Goldsboro North Carolina
United States CHI Health Saint Francis Grand Island Nebraska
United States Saint Mary's Hospital and Regional Medical Center Grand Junction Colorado
United States Cancer Research Consortium of West Michigan NCORP Grand Rapids Michigan
United States Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin
United States Franklin Medical Center Greenfield Massachusetts
United States The Cancer Institute of New Jersey Hamilton Hamilton New Jersey
United States Hattiesburg Clinic - Hematology/Oncology Clinic Hattiesburg Mississippi
United States Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States IU Health Methodist Hospital Indianapolis Indiana
United States Baptist MD Anderson Cancer Center Jacksonville Florida
United States Mayo Clinic in Florida Jacksonville Florida
United States East Tennessee State University Johnson City Tennessee
United States Jupiter Medical Center Jupiter Florida
United States West Michigan Cancer Center Kalamazoo Michigan
United States University of Kansas Cancer Center Kansas City Kansas
United States UC San Diego Moores Cancer Center La Jolla California
United States Lakeland Regional Health Hollis Cancer Center Lakeland Florida
United States Saint Mary Medical and Regional Cancer Center Langhorne Pennsylvania
United States Nevada Cancer Research Foundation CCOP Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Cancer Centers of Southwest Oklahoma Research Lawton Oklahoma
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States The James Graham Brown Cancer Center at University of Louisville Louisville Kentucky
United States Medical Center of Central Georgia Macon Georgia
United States University of Wisconsin Hospital and Clinics Madison Wisconsin
United States Manchester Memorial Hospital Manchester Connecticut
United States Holy Family Memorial Hospital Manitowoc Wisconsin
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Loyola University Medical Center Maywood Illinois
United States Mount Sinai Medical Center Miami Beach Florida
United States Orange Regional Medical Center Middletown New York
United States Mobile Infirmary Medical Center Mobile Alabama
United States Skagit Valley Hospital Mount Vernon Washington
United States IU Health Ball Memorial Hospital Muncie Indiana
United States Vanderbilt University/Ingram Cancer Center Nashville Tennessee
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York
United States ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Immanuel Medical Center Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Nebraska Methodist Hospital Omaha Nebraska
United States University of Nebraska Medical Center Omaha Nebraska
United States Saint Joseph Hospital - Orange Orange California
United States AdventHealth Orlando Orlando Florida
United States Stanford Cancer Institute Palo Alto Palo Alto California
United States VA Palo Alto Health Care System Palo Alto California
United States Paoli Memorial Hospital Paoli Pennsylvania
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States University of Pennsylvania/Abramson Cancer Center Philadelphia Pennsylvania
United States University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania
United States Providence Portland Medical Center Portland Oregon
United States Pottstown Hospital Pottstown Pennsylvania
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Interlakes Foundation Inc-Rochester Rochester New York
United States Mayo Clinic Rochester Minnesota
United States University of Rochester Rochester New York
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Saint Louis-Cape Girardeau CCOP Saint Louis Missouri
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States Kaiser Permanente-San Diego Mission San Diego California
United States Naval Medical Center -San Diego San Diego California
United States Veterans Administration-San Diego Medical Center San Diego California
United States Guthrie Medical Group PC-Robert Packer Hospital Sayre Pennsylvania
United States Mayo Clinic in Arizona Scottsdale Arizona
United States Kaiser Permanente Washington Seattle Washington
United States Swedish Medical Center-First Hill Seattle Washington
United States Siouxland Regional Cancer Center Sioux City Iowa
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Baystate Medical Center Springfield Massachusetts
United States Cancer Research for the Ozarks NCORP Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Stony Brook University Medical Center Stony Brook New York
United States Banner University Medical Center - Tucson Tucson Arizona
United States Natalie Warren Bryant Cancer Center at Saint Francis Tulsa Oklahoma
United States Saint John Medical Center Tulsa Oklahoma
United States Carle Cancer Center Urbana Illinois
United States South Georgia Medical Center/Pearlman Cancer Center Valdosta Georgia
United States New York Medical College Valhalla New York
United States ProHealth Waukesha Memorial Hospital Waukesha Wisconsin
United States Florida Cancer Specialists-West Palm Beach West Palm Beach Florida
United States Cleveland Clinic-Weston Weston Florida
United States Wichita NCI Community Oncology Research Program Wichita Kansas
United States Southeast Clinical Oncology Research (SCOR) Consortium NCORP Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival Overall survival is defined as time from randomization to death from any cause. assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15
Primary Recurrence Free Survival Recurrence free survival is defined as time from randomization to first disease recurrence or death from any cause (whichever occur first), censoring cases without recurrence or death at the last date of known free of recurrence free survival events. Disease recurrence was determined based on positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease, or a positive brain CT or MRI scan or CSF cytology. assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15
Secondary Overall Survival in Human Leukocyte Antigens-A2 (HLA-A2) Positive Patients Overall survival is defined as time from randomization to death from any cause. assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years,up to year 15
Secondary Recurrence Free Survival in HLA-A2 Positive Patients Recurrence free survival is defined as time from randomization to first disease recurrence or death from any cause (whichever occur first), censoring cases without recurrence or death at the last date of known free of recurrence free survival events. Disease recurrence was determined based on positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease, or a positive brain CT or MRI scan or CSF cytology. assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15
Secondary 5-year Overall Survival Rate Overall survival is defined as time from randomization to death from any cause, and 5-year overall survival rate is estimated via Kaplan-Meier method. assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15
Secondary 5-year Recurrence Free Survival Rate Recurrence free survival is defined as time from randomization to first disease recurrence or death from any cause (whichever occur first), censoring cases without recurrence or death at the last date of known free of recurrence free survival events, and 5-year overall survival rate is estimated via Kaplan-Meier method. Disease recurrence was determined based on positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease, or a positive brain CT or MRI scan or CSF cytology. assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15
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