SWOG clinical trial number
E4697

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

Closed
Phase
Published
Abbreviated Title
GM-CSF/Peptide Vaccination/Placebo/Stage IV
Activated
03/01/2002
Closed
10/31/2006
Participants
NCORP, Members, Medical Oncologists, Surgeons, Pathologists

Research committees

Melanoma

Treatment

GM-CSF Surgery Tyrosinase:368-376 (370D)

Eligibility Criteria Expand/Collapse

Pts must have HLA-A2 status known prior to randomization; Pts must have completely resected disease w/any one of the following: any locoregional recurrence after prior adjuvant interferon or failure on S0008, any local recurrence of disease after adequate surgical excision of the original primary, mucosal melanoma or Stage IV melanoma (cutaneous, ocular, mucosal, or unknown primary); Pts in the following groups who are not eligible for S0008 or are medically unfit to receive standard high-dose interferon are eligible: Any clinically evident satellite or in-transit disease, Stage III disease w/gross extacapsular extension, recurrence in a previously resected nodal basin, four or more involved lymph nodes, or matted lymph nodes or an ulcerated primary melanoma and any involved lymph nodes; No prior treatment with GM-CSF; Pts must be surgically rendered free of disease w/negative margins on resected specimens; ECOG PS of 0-1; No adjuvant treatment after surgical qualifying resection; One systemic treatment after a prior surgery is allowed; Pts must have a brain CT or MRI, chest CT or CXR and abdominal CT or MRI; WBC >/= 3,000/mm3, platelets > 100,000/mm3, SGOT and bilirubin < 2 X IULN, serum creatinine < 1.8 mg/dl, LDH = normal and alkaline phosphatase < 1.25 X IULN (eligible w/negative CT or MRI of the liver and negative bone scan or negative PET scan).

Publication Information Expand/Collapse

2017

Immune correlates of GM-CSF and melanoma peptide vaccination in a randomized trial for the adjuvant therapy of resected high-risk melanoma (E4697)

L Butterfield;F Zhao;S Lee;A Tarhini;K Margolin;R White;M Atkins;G Cohen;T Whiteside;D Lawson Clinical Cancer Research Sep 1;23(17):5034-5043; May 23 [Epub ahead of print], 2017

PMid: PMID28536308 | PMC number: PMC5581724

2010

E4697: Phase III cooperative group study of yeast-derived granulocyte macrophage colony-stimulating factor (GM-CSF) versus placebo as adjuvant treatment of patients with completely resected stage III-IV melanoma

DH Lawson;SJ Lee;AH Tarhini;K Margolin;M Ernstoff;JM Kirkwood Journal of Clinical Oncology 28:7s(suppl; abstr 8504); oral presentation

Other Clinical Trials

SWOG Clinical Trial Number
S2000
SWOG Clinical Trial Number
CTSU/EA6174