Recurrent Melanoma Clinical Trial
Official title:
A Randomized, Placebo-Controlled Phase III Trial of Yeast Derived GM-CSF Versus Peptide Vaccination Versus GM-CSF Plus Peptide Vaccination Versus Placebo in Patients With "No Evidence of Disease" After Complete Surgical Resection of "Locally Advanced" and/or Stage IV Melanoma
Verified date | June 2020 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
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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