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Clinical Trial: Vaccine Therapy and/or Sargramostim in Treating Patients With Locally Advanced or Metastatic Melanoma
This study is currently recruiting patients.
Purpose
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. It is not yet known which treatment regimen is more effective for melanoma.
PURPOSE: This randomized phase III trial is studying peptide vaccine therapy and/or sargramostim and comparing how well they work in treating patients with locally advanced or metastatic melanoma.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| intraocular melanoma Melanoma | Drug: MART-1 antigen Drug: Montanide ISA-51 Drug: gp100 antigen Drug: sargramostim Drug: tyrosinase peptide Procedure: adjuvant therapy Procedure: biological response modifier therapy Procedure: colony-stimulating factor therapy Procedure: cytokine therapy Procedure: non-specific immune-modulator therapy Procedure: non-tumor cell derivative vaccine Procedure: vaccine therapy | Phase III |
MedlinePlus related topics: Eye Cancer; Melanoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Sargramostim (GM-CSF) and Peptide Vaccination Comprised of Tyrosinase:368-376, gp100:209-217 (210M) Antigen, and MART-1:27-35 Peptide Versus Peptide Vaccination Alone Versus GM-CSF Alone Versus Placebo in Patients With Locally Advanced or Metastatic Melanoma
Further Study Details:
OBJECTIVES:
- Compare overall survival, two-year survival, and time to progression in HLA-A2-positive or negative patients with completely resected locally advanced or metastatic melanoma treated with or without sargramostim (GM-CSF).
- Compare overall survival, two-year survival, and time to progression in HLA-A2-positive patients treated with peptide vaccination comprised of tyrosinase:368-376, gp100:209-217 (210M) antigen, and MART-1:27-35 peptide vs no peptide vaccination.
- Compare the influence of GM-CSF on circulating dendritic cell numbers and subpopulations in peripheral blood of patients treated with or without GM-CSF.
- Determine whether immunization with peptides with or without GM-CSF elicits a measurable T-cell response in HLA-A2-positive patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified by HLA-A2 status (positive vs negative), site of metastases this occurrence (visceral vs nonvisceral vs visceral and nonvisceral vs no metastases), and number of metastases this occurrence (1 vs 2 or 3 vs 4 or more vs 0).
Patients are assigned to one of two treatment groups based on HLA-A2 status.
- Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive sargramostim (GM-CSF) subcutaneously (SC) daily on days 1-14. Patients receive peptide vaccination comprising the following 3 peptides: tyrosinase:368-376, gp100:209-217 (210M) antigen (gp100), and MART-1:27-35 peptide. Each peptide is emulsified separately in Montanide ISA-51 (ISA-51) and administered separately via 2 SC injections into 3 different sites on days 1 and 15 of course 1 and on day 1 of subsequent courses.
- Arm II: Patients receive GM-CSF placebo SC on days 1-14. Patients receive peptide vaccination as in arm I.
- Arm III: Patients receive GM-CSF as in arm I. Patients receive peptide vaccination placebo comprising tyrosinase placebo, gp100 placebo, and MART -1 placebo. Each peptide placebo is emulsified separately in ISA-51 and administered separately via 2 SC injections into 3 different sites on days 1 and 15 of course 1 and on day 1 of subsequent courses.
- Arm IV: Patients receive GM-CSF placebo as in arm II and peptide vaccination placebo as in arm III.
- Patients are randomized to 1 of 2 treatment arms.
- Arm V: Patients receive GM-CSF SC as in arm I.
- Arm VI: Patients receive GM-CSF placebo as in arm II. Treatment in both groups repeats every 4 weeks for 13 courses in the absence of disease progression. Patients who develop unresectable recurrent disease are taken off study, whereas those who develop resectable recurrent disease undergo complete resection and may continue treatment on the arm to which they were originally randomized for 6 additional courses or until they complete 1 year of protocol treatment. Patients who develop a second recurrence are taken off study.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for up to 10 years.
PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study within 45 months.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Histologically proven completely resected melanoma including one of the following:
- Any locoregional recurrence after prior adjuvant interferon or failure on SWOG-0008
- Any local recurrence after adequate surgical excision of the original primary
- Mucosal melanoma
- Stage IV disease including:
- Cutaneous melanoma
- Ocular melanoma
- Mucosal melanoma
- Multiple primary lesions allowed
- If ineligible for SWOG-0008 or are determined by managing physician to be medically unfit to receive standard high-dose interferon, patients with one of the following may be eligible:
- Any clinically evident satellite or intransit disease
- Stage III disease with gross extracapsular extension
- Recurrence in previously resected nodal basin
- Four or more involved lymph nodes or matted lymph nodes
- Ulcerated primary melanoma and any involved lymph nodes
- Known HLA-A2 status
- Rendered free of disease with negative margins by surgical means only
- Ineligible if rendered free of disease by nonsurgical means
- Must be randomized within 16 weeks of surgical resection
- If more than one surgical procedure is required to render the patient disease free, all required surgeries must be completed within this 16-week time period
- Patients with bone pain must have a negative bone scan
PATIENT CHARACTERISTICS: Age:
- 18 and over
Performance status:
- ECOG 0 or 1
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- SGOT no greater than 2 times upper limit of normal (ULN)
- Bilirubin no greater than 2 times ULN
- LDH normal
- Alkaline phosphatase no greater than ULN (1.25 times ULN if negative CT scan or MRI of liver and negative bone scan or negative PET scan)
Renal:
- Creatinine no greater than 1.8 mg/dL
Other:
- No active infection requiring treatment with IV antibiotics
- No other significant medical, surgical, or psychiatric condition or requirement for medication or treatment that would preclude study compliance
- No diagnosis or evidence of organic brain syndrome or significant impairment of basal cognitive function that would preclude study compliance
- Able to self administer or arrange for administration of subcutaneous injections
- No other malignancy within the past 5 years except any of the following curatively treated cancers:
- Lobular carcinoma in situ of the breast
- Carcinoma in situ of the cervix
- Any other in situ cancer
- Atypical melanocytic hyperplasia
- Clark's level I melanoma (melanoma in situ)
- Basal cell or squamous cell skin cancer
- No autoimmune disorder
- No condition of immunosuppression
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 18 months after study participation
PRIOR CONCURRENT THERAPY: Biologic therapy:
- See Disease Characteristics
- No prior sargramostim (GM-CSF)
- No prior MART-1:27-35 peptide, tyrosinase:368-376, or gp100:209-217 (210M) antigen
- No prior adjuvant biologic therapy after resection(s) that rendered the patient disease-free with negative margins
- One prior systemic regimen after prior surgery allowed if completed at least 8 weeks ago
- Chemotherapy and biologic therapy administered together as one planned treatment count as one regimen
Chemotherapy:
- See Biologic therapy
- No prior adjuvant chemotherapy after resection(s) that rendered the patient disease-free with negative margins
Endocrine therapy:
- At least 2 weeks since prior systemic corticosteroids, including oral steroids (e.g., prednisone or dexamethasone)
- At least 2 weeks since prior continuous use of topical steroid creams or ointments or any steroid-containing inhalers
- Concurrent replacement doses of steroids for adrenal insufficiency allowed
- No concurrent systemic corticosteroids, including oral steroids (e.g., prednisone or dexamethasone)
- No concurrent continuous use of topical steroid creams or ointments or any steroid-containing inhalers
Radiotherapy:
- At least 30 days since prior radiotherapy, including after the resection
Surgery:
- See Disease Characteristics
- See Biologic therapy
- See Chemotherapy
- See Radiotherapy
Other:
- No prior adjuvant limb perfusion after resection(s) that rendered the patient disease-free with negative margins
- No concurrent IV antibiotics
Location and Contact Information
Alabama
MBCCOP - Gulf Coast, Mobile, Alabama, 36607, United States; Recruiting
Paul O. Schwarzenberger, MD 251-544-1013
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, 35294-3300, United States; Recruiting
Carla I. Falkson, MD 205-975-2691 cfalkson@uab.edu
Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, 85724, United States; Recruiting
Thomas P. Miller, MD 520-626-2667
CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale, Arizona, 85259-5404, United States; Recruiting
Tom Robert Fitch, MD 480-301-9875
CCOP - Western Regional, Arizona, Phoenix, Arizona, 85006-2726, United States; Recruiting
David Kyle King, MD, FACP 602-239-2413 david.king@baannerhealth.com
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden), Phoenix, Arizona, 85012, United States; Recruiting
Thomas Dale Kummet, MD 602-277-5551
Veterans Affairs Medical Center - Tucson, Tucson, Arizona, 85723, United States; Recruiting
Harinder S. Garewal, MD 520-629-4686
Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States; Recruiting
Laura Fulper Hutchins, MD 501-686-8511 LFHutchins@uams.edu
Veterans Affairs Medical Center - Little Rock, Little Rock, Arkansas, 72205, United States; Recruiting
Bart Barlogie, MD 501-526-2873
California
CCOP - Bay Area Tumor Institute, Oakland, California, 94609-3305, United States; Recruiting
Joseph Szumowski, MD 510-465-8570
CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, 95403, United States; Recruiting
Ian C. Anderson, MD 707-521-3830
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange, California, 92868, United States; Recruiting
Randall F. Holcombe, MD 714-456-5153 rholcomb@uci.edu
City of Hope Comprehensive Cancer Center, Duarte, California, 91010-3000, United States; Recruiting
Clinical Trials Office - New Patient Services 800-826-4673 becomingapatient@coh.org
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095-1781, United States; Recruiting
John L. Barstis, MD 310-825-5268
Stanford Cancer Center at Stanford University Medical Center, Stanford, California, 94305-5216, United States; Recruiting
Harlan A. Pinto, MD 650-725-9057
University of California Davis Cancer Center, Sacramento, California, 95817, United States; Recruiting
David R. Gandara, MD 916-734-3772 dgandara@cc.ucdmc.ucdavis.edu
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, 90033, United States; Recruiting
Heinz-Josef Lenz, MD 323-865-3955 lenz@usc.edu
Veterans Affairs Medical Center - Loma Linda (Pettis), Loma Linda, California, 92357, United States; Recruiting
Mark E. Reeves, MD, PhD 909-583-6064
Veterans Affairs Medical Center - Palo Alto, Palo Alto, California, 94304-1290, United States; Recruiting
Harlan A. Pinto, MD 650-493-5000 ext. 4948
Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, 94553, United States; Recruiting
David R. Gandara, MD 925-372-2064
Colorado
Boulder Community Hospital, Boulder, Colorado, 80301-9019, United States; Recruiting
John Thomas Fleagle, MD 303-440-2399
CCOP - Colorado Cancer Research Program, Incorporated, Denver, Colorado, 80224, United States; Recruiting
Eduardo R. Pajon, MD 303-777-2663 erpajon@aol.com
Hope Cancer Care Center at Longmont United Hospital, Longmont, Colorado, 80501, United States; Recruiting
Robert Evan Fisher, MD 303-485-4132
Medical Center of Aurora - South Campus, Aurora, Colorado, 80012-0000, United States; Recruiting
Sami G. Diab, MD 303-418-7600
Penrose Cancer Center at Penrose Hospital, Colorado Springs, Colorado, 80933, United States; Recruiting
Robert Lynn Sayre, MD 719-577-2555
Porter Adventist Hospital, Denver, Colorado, 80210, United States; Recruiting
David Trevarthen, MD 303-788-8675
Presbyterian - St. Luke's Medical Center, Denver, Colorado, 80218, United States; Recruiting
Robert M. Jotte, MD, PhD 303-388-4876
Rocky Mountain Cancer Centers - Denver Rose, Denver, Colorado, 80220, United States; Recruiting
Scot M. Sedlacek, MD 303-321-0302
Rocky Mountain Cancer Centers - Thornton, Thornton, Colorado, 80229, United States; Recruiting
Alvin L. Otsuka, MD 303-386-7622 aotsuka@direcpc.com
Sky Ridge Medical Center, Lone Tree, Colorado, 80124, United States; Recruiting
Dennis Carter, MD 720-225-4200
St. Joseph Hospital, Denver, Colorado, 80218-1191, United States; Recruiting
Michael McLaughlin, MD 303-861-3302
St. Mary-Corwin Regional Medical Center, Pueblo, Colorado, 81004, United States; Recruiting
Marlow M. Sloan, MD 719-560-6000
Swedish Medical Center, Englewood, Colorado, 80112, United States; Recruiting
Marshall Davis, MD 303-788-5860
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora, Colorado, 80010, United States; Recruiting
Anthony D. Elias, MD 720-848-1622 Anthony.Elias@uchsc.edu
Veterans Affairs Medical Center - Denver, Denver, Colorado, 80220, United States; Recruiting
Madeleine A. Kane, MD, PhD 303-399-8020 ext. 3129 madeleine.kane@med.va.gov
District of Columbia
MBCCOP - Howard University Cancer Center, Washington, District of Columbia, 20060, United States; Recruiting
Lucile L. Adams-Campbell, PhD 202-806-7697
Florida
Veterans Affairs Medical Center - Tampa (Haley), Tampa, Florida, 33612, United States; Recruiting
Raoul R. Salup, MD 813-972-7579 raoul.salup@med.va.gov
Georgia
CCOP - Atlanta Regional, Atlanta, Georgia, 30342-1701, United States; Recruiting
Thomas E. Seay, MD, PhD 404-851-2340
Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia, 30033, United States; Recruiting
Maria Jose Amarante Ribeiro, MD 404-728-7680 maria.ribeiro@med.va.gov
Winship Cancer Institute of Emory University, Atlanta, Georgia, 30322, United States; Recruiting
William Costin Wood, MD 404-778-5180
Hawaii
MBCCOP - Hawaii, Honolulu, Hawaii, 96813, United States; Recruiting
Brian F. Issell, MD 808-586-3015 brian@crch.hawaii.edu
Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, 60153-5500, United States; Recruiting
Patrick J. Stiff, MD 708-327-3148
CCOP - Carle Cancer Center, Urbana, Illinois, 61801, United States; Recruiting
Kendrith M. Rowland, MD 217-383-4083 kendrith.rowland@carle.com
CCOP - Central Illinois, Decatur, Illinois, 62526, United States; Recruiting
James L. Wade, MD 217-876-6617 jlwade3@sbcglobal.net
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, 60612, United States; Recruiting
Lawrence Eric Feldman, MD 312-335-3614
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, 60611, United States; Recruiting
Al Bowen Benson, MD, FACP 312-695-1382
Swedish-American Regional Cancer Center, Rockford, Illinois, 61104-2315, United States; Recruiting
Lori Kline, RN, BS 815-489-4413 lkline@swedishamerican.org
Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, 60612, United States; Recruiting
Lawrence Eric Feldman, MD 312-569-6129
Veterans Affairs Medical Center - Hines, Hines, Illinois, 60141, United States; Recruiting
Nirmala Bhoopalam, MD 708-202-2782
Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois, 60611-4494, United States; Recruiting
Timothy M. Kuzel, MD 312-469-3748
Indiana
Indiana University Cancer Center, Indianapolis, Indiana, 46202-5289, United States; Recruiting
Patrick J. Loehrer, MD 317-278-7418
Iowa
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, 52403-1206, United States; Recruiting
Martin Wiesenfeld, MD 319-363-8303
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, 50309-1016, United States; Recruiting
Roscoe F. Morton, MD, FACP 515-244-7586
Kansas
CCOP - Wichita, Wichita, Kansas, 67214-3882, United States; Recruiting
Shaker R. Dakhil, MD, FACP 316-268-5784
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, 66160-7353, United States; Recruiting
Sarah A. Taylor, MD 913-588-6029 sataylor@kumc.edu
Veterans Affairs Medical Center - Wichita, Wichita, Kansas, 67218, United States; Recruiting
Shaker R. Dakhil, MD, FACP 316-685-2221
Kentucky
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, 40536-0084, United States; Recruiting
Michael A. Doukas, MD 859-257-3379
Veterans Affairs Medical Center - Lexington, Lexington, Kentucky, 40502-2236, United States; Recruiting
Michael A. Doukas, MD 859-281-4956
Louisiana
CCOP - Ochsner, New Orleans, Louisiana, 70121, United States; Recruiting
Carl G. Kardinal, MD 504-842-3910
Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, 71130-3932, United States; Recruiting
Glenn M. Mills, MD 318-675-5970 gmills@lsuhsc.edu
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, 70112, United States; Recruiting
Jill Gilbert, MD 504-568-5613 jgilbe@lsuhsc.edu
Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans, Louisiana, 70112, United States; Recruiting
Alan M. Miller, MD, PhD 504-587-7566 amiller@tulane.edu
Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana, 70112, United States; Recruiting
German S. Beltran, MD 504-588-5482
Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana, 71101-4295, United States; Recruiting
Glenn M. Mills, MD 318-221-8411
Maryland
Johns Hopkins at Green Spring Station, Lutherville, Maryland, 21093, United States; Recruiting
William Howard Sharfman, MD 410-583-2970
Massachusetts
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States; Recruiting
Michael Benjamin Atkins, MD 617-667-1930
Cancer Center at Tufts - New England Medical Center, Boston, Massachusetts, 02111, United States; Recruiting
John K. Erban, MD 617-636-5147 jerban@tufts-nemc.org
Cancer Research Center at Boston Medical Center, Boston, Massachusetts, 02118, United States; Recruiting
Douglas V. Faller, MD, PhD 617-638-4173
Michigan
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, 48201-1379, United States; Recruiting
Lawrence E. Flaherty, MD 313-745-9155 flaherty@karmanos.org
CCOP - Beaumont, Royal Oak, Michigan, 48073-6769, United States; Recruiting
Jeanne Archer, PhD, APN 248-551-8299 carcher@beaumon.edu
CCOP - Grand Rapids, Grand Rapids, Michigan, 49503, United States; Recruiting
Kathleen Jo Yost, MD 616-391-1230
CCOP - Kalamazoo, Kalamazoo, Michigan, 49007-3731, United States; Recruiting
Raymond Sterling Lord, MD 269-373-7488 rlord@wmcc.org
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, 48106, United States; Recruiting
Philip J. Stella, MD 734-712-5237 beekmanl@trinity-health.org
Josephine Ford Cancer Center at Henry Ford Health System, Detroit, Michigan, 48202, United States; Recruiting
Robert Anthony Chapman, MD 313-916-1332 rchapma1@hfhs.org
Providence Cancer Institute at Providence Hospital - Southfield, Southfield, Michigan, 48075, United States; Recruiting
Anibal Drelichman, MD, MPH, FACP 313-552-0620 adrelichman@yahoo.com
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109-0948, United States; Recruiting
Laurence H. Baker, DO, FACOI 734-936-3983 bakerl@umich.edu
Veterans Affairs Medical Center - Detroit, Detroit, Michigan, 48201-1932, United States; Recruiting
Lawrence E. Flaherty, MD 313-576-1000
West Michigan Cancer Center, Kalamazoo, Michigan, 49007-3731, United States; Recruiting
Raymond Sterling Lord, MD 616-373-7488 rlord@wmcc.org
Minnesota
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, 55416, United States; Recruiting
Patrick J. Flynn, MD 952-993-1517 patrick.flynn@usoncology.com
Mayo Clinic Cancer Center, Rochester, Minnesota, 55905, United States; Recruiting
Thomas M. Habermann, MD 507-284-2511
Mississippi
University of Mississippi Medical Center, Jackson, Mississippi, 39216-4505, United States; Recruiting
James Tate Thigpen, MD 601-984-5590 jthigpen@medicine.umsmed.edu
Veterans Affairs Medical Center - Jackson, Jackson, Mississippi, 39216, United States; Recruiting
James Tate Thigpen, MD 601-362-4471
Missouri
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, 65807, United States; Recruiting
John Wendall Goodwin, MD 417-269-4520 jwg684@sprg.mercy.net
CCOP - Kansas City, Kansas City, Missouri, 64131, United States; Recruiting
William T. Stephenson, MD 816-823-0555
CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, 63141, United States; Recruiting
Bethany G. Sleckman, MD 314-569-6573
Saint Louis University Cancer Center, Saint Louis, Missouri, 63110, United States; Recruiting
Paul J. Petruska, MD 314-268-5451 petruspj@slu.edu
Montana
CCOP - Montana Cancer Consortium, Billings, Montana, 59101, United States; Recruiting
Patrick W. Cobb, MD 406-259-2245
Nevada
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, 89106, United States; Recruiting
John Allan Ellerton, MD, CM 702-384-0013 k.vanwagenen@sncrf.org
New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, 03756-0002, United States; Recruiting
Camilo E. Fadul, MD 603-650-6312 Camilo.e.fadul@dartmouth.edu
New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, 08903, United States; Recruiting
Joseph Aisner, MD 732-235-7401 aisnerjo@umdnj.edu
Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, 07018, United States; Recruiting
Basil S. Kasimis, MD, DSc 973-676-1000 ext. 7095 Basil.Kasimis@med.va.gov
New Mexico
MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico, 87131, United States; Recruiting
Cheryl L. Willman, MD 505-272-5837
Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico, 87108-5138, United States; Recruiting
Cheryl L. Willman, MD 505-265-1711
New York
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, 10032, United States; Recruiting
Daniel P. Petrylak, MD 212-305-1731 dpp5@columbia.edu
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, 14642, United States; Recruiting
Richard I. Fisher, MD 585-275-0842 richard_fisher@urmc.rochester.edu
MBCCOP-Our Lady of Mercy Cancer Center, Bronx, New York, 10466, United States; Recruiting
Peter H. Wiernik, MD 718-920-9900 pwiernik@olmhs.org
NYU Cancer Institute at New York University Medical Center, New York, New York, 10016, United States; Recruiting
Amy D. Tiersten, MD 212-652-1916
North Carolina
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina, 27534-9479, United States; Recruiting
James N. Atkins, MD 336-777-3088
Ohio
CCOP - Columbus, Columbus, Ohio, 43206, United States; Recruiting
J. Philip Kuebler, MD, PhD 614-488-2118
CCOP - Dayton, Dayton, Ohio, 45429, United States; Recruiting
Howard M. Gross, MD 937-832-1093
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, 45267-0501, United States; Recruiting
Abdul-Rahman Jazieh, MD, MPH 513-584-3830
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, 44195-9001, United States; Recruiting
George Thomas Budd, MD 216-444-6480
MetroHealth's Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio, 44109, United States; Recruiting
Edward G. Mansour, MD 216-778-4394 emansour@metrohealth.org
Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio, 45220-2288, United States; Recruiting
Albert F. Muhleman, MD 513-475-6537 albert.muhleman@med.va.gov
Veterans Affairs Medical Center - Dayton, Dayton, Ohio, 45428-1002, United States; Recruiting
Howard M. Gross, MD 937-268-6511
Oklahoma
CCOP - Oklahoma, Tulsa, Oklahoma, 74136, United States; Recruiting
James B. Lockhart, MD 918-491-5878
Oklahoma University Medical Center, Oklahoma City, Oklahoma, 73104, United States; Recruiting
Daniel J. Culkin, MD, FACS 405-271-6900 daniel-culkin@ouhsc.edu
Oregon
Cancer Institute at Oregon Health and Science University, Portland, Oregon, 97201-3098, United States; Recruiting
Craig R. Nichols, MD 503-494-6346
CCOP - Columbia River Oncology Program, Portland, Oregon, 97225, United States; Recruiting
Keith S. Lanier, MD 503-216-6260
Veterans Affairs Medical Center - Portland, Portland, Oregon, 97207, United States; Recruiting
Christopher W. Ryan, MD 503-220-8262
Pennsylvania
Abramson Cancer Center at the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States; Recruiting
Daniel G. Haller, MD 215-662-6318
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, 17822-2001, United States; Recruiting
Albert M. Bernath, MD 570-271-6466
Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111-2497, United States; Recruiting
Lori J. Goldstein, MD 215-728-2689 lj_goldstein@fccc.edu
Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, 15236, United States; Recruiting
John Munn Kirkwood, MD 412-692-4724
South Carolina
CCOP - Greenville, Greenville, South Carolina, 29615, United States; Recruiting
Jeffrey Kent Giguere, MD 864-241-6251
CCOP - Upstate Carolina, Spartanburg, South Carolina, 29303, United States; Recruiting
James Dewitt Bearden, MD 864-560-7050
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, 29425, United States; Recruiting
Carolyn E. Reed, MD 843-792-9321 reedce@musc.edu
Veterans Affairs Medical Center - Charleston, Charleston, South Carolina, 29401-5799, United States; Recruiting
Carolyn E. Reed, MD 843-789-7804
South Dakota
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, 57104, United States; Recruiting
Loren K. Tschetter, MD 605-328-8044 tidemanb@siouxvalley.org
Tennessee
University of Tennessee Cancer Institute at Methodist Central Hospital, Memphis, Tennessee, 38104, United States; Recruiting
Mohammad Jahanzeb, MD 901-722-0532
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville, Tennessee, 37232-6307, United States; Recruiting
David Horton Johnson, MD 615-343-9454 david.h.johnson@vanderbilt.edu
Veterans Affairs Medical Center - Memphis, Memphis, Tennessee, 38104, United States; Recruiting
Harvey B. Niell, MD 901-523-8990 ext. 5533
Texas
Brooke Army Medical Center, Fort Sam Houston, Texas, 78234-6200, United States; Recruiting
Mitchell A. Garrison, MD 210-916-3281 mitchell.garrison@cen.amedd.army.mil
CCOP - Scott and White Hospital, Temple, Texas, 76508, United States; Recruiting
Lucas Wong, MD 254-724-1053 lwong@swmail.sw.org
Harrington Cancer Center, Amarillo, Texas, 79106, United States; Recruiting
James E. Clarkson, MD 806-359-4673 ext. 228 jclarkson@harringtoncc.org
MD Anderson Cancer Center at University of Texas, Houston, Texas, 77030-4095, United States; Recruiting
Scott Michael Lippman, MD, FACP 713-745-3672
University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229-3900, United States; Recruiting
Geoffrey R. Weiss, MD 210-567-4777 weiss@uthscsa.edu
University of Texas Medical Branch, Galveston, Texas, 77555-0565, United States; Recruiting
Robert P. Whitehead, MD 409-772-1164 rpwhiteh@utmb.edu
Veterans Affairs Medical Center - Amarillo, Amarillo, Texas, 79106, United States; Recruiting
Stephen E. Wright, MD 806-359-4673 ext. 230
Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas, 78229, United States; Recruiting
Geoffrey R. Weiss, MD 210-617-5186
Veterans Affairs Medical Center - Temple, Temple, Texas, 76504, United States; Recruiting
Phalguni Mukhopadhyay, MD 254-778-4811 ext. 4809
Utah
Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, 84112-5550, United States; Recruiting
Wolfram Samlowski, MD 801-585-0255 wolfram.samlowski@hci.utah.edu
Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah, 84148, United States; Recruiting
Wolfram Samlowski, MD 801-582-1565 ext. 1272
Washington
CCOP - Northwest, Tacoma, Washington, 98405-0986, United States; Recruiting
Lauren Kenneth Colman, MD 253-403-5259 lauren.colman@multicare.org
CCOP - Virginia Mason Research Center, Seattle, Washington, 98101, United States; Recruiting
Andrew David Jacobs, MD 206-341-0446
Puget Sound Oncology Consortium, Seattle, Washington, 98109, United States; Recruiting
Saul E. Rivkin, MD 206-386-2441
Veterans Affairs Medical Center - Seattle, Seattle, Washington, 98108, United States; Recruiting
William H. Schubach, MD 206-764-2265
Wisconsin
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin, 54449, United States; Recruiting
Tarit Kumar Banerjee, MD, FACP 715-387-5511
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, 53792-0001, United States; Recruiting
James A. Stewart, MD 608-265-8131 stewart@biostat.wisc.edu
Study chairs or principal investigators
David H. Lawson, MD, Study Chair, Winship Cancer Institute of Emory University
Kim Allyson Margolin, MD, Study Chair, Beckman Research Institute
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Publications
Falkson CI, Lawson DH, Ibrahim J, et al.: A randomised, placebo-controlled phase III trial of yeast derived GM-CSF vs. peptide vaccination vs. GM-CSF plus peptide vaccination vs. placebo in pts with ‘no evidence of disease’ after complete surgical resection of ‘locally advanced’ and / or stage IV melanoma. An Eastern Cooperative group trial . [Abstract] 4th International Conference on the Adjuvant Therapy of Malignant Melanoma, 15th-16th March 2002, London, UK A-I-03, 2002.
Study ID Numbers: CDR0000067568; ECOG-4697; SWOG-E4697; NCT00005034
Record last reviewed: March 2005
Last Updated: April 4, 2005
Record first received: April 6, 2000
ClinicalTrials.gov Identifier: NCT00005034
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: March 2005
Last Updated: April 4, 2005
Record first received: April 6, 2000
ClinicalTrials.gov Identifier: NCT00005034
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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