Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma



Status:Recruiting
Conditions:Lung Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:Any - 50
Updated:2/17/2019
Start Date:December 8, 2014
End Date:December 31, 2020

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Randomized Phase 3 Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab (AMG 479, NSC# 750008) to Multiagent Chemotherapy for Patients With Newly Diagnosed Metastatic Ewing Sarcoma

This randomized phase III trial studies how well combination chemotherapy with or without
ganitumab works in treating patients with newly diagnosed Ewing sarcoma that has spread to
other parts of the body. Immunotherapy with monoclonal antibodies, such as ganitumab, may
help the body's immune system attack the cancer, and may interfere with the ability of tumor
cells to grow and spread. Drugs used in chemotherapy, such as vincristine sulfate,
doxorubicin hydrochloride, cyclophosphamide, ifosfamide, and etoposide, work in different
ways to stop the growth of tumor cells, either by killing the cells, by stopping them from
dividing, or by stopping them from spreading. It is not yet known whether combination
chemotherapy is more effective with or without ganitumab in treating patients with newly
diagnosed Ewing sarcoma.

PRIMARY OBJECTIVES:

I. To determine if the event-free survival (EFS) in patients with newly diagnosed metastatic
Ewing sarcoma treated with multiagent chemotherapy is improved with the addition of ganitumab
(AMG 479).

SECONDARY OBJECTIVES:

I. To describe the toxicity of the addition of ganitumab to multimodality therapy for
patients with newly diagnosed metastatic Ewing sarcoma.

II. To compare overall survival in patients with newly diagnosed metastatic Ewing sarcoma
treated with multiagent chemotherapy with and without the addition of ganitumab.

EXPLORATORY OBJECTIVES:

I. To compare bone marrow response rates in patients with newly diagnosed metastatic Ewing
sarcoma treated with multiagent chemotherapy with and without the addition of ganitumab.

II. To describe the toxicity of 6 months of ganitumab monotherapy as maintenance therapy
following multimodality therapy in patients with newly diagnosed metastatic Ewing sarcoma.

III. To describe trough levels of ganitumab in a cohort of patients with Ewing sarcoma < 21
years of age treated with 18 mg/kg.

IV. To describe the feasibility of and local failure rates following hypofractionated
stereotactic body radiotherapy (SBRT) directed at bone metastases in patients with newly
diagnosed metastatic Ewing sarcoma.

V. To determine if EFS, overall survival, bone marrow response rates, and toxicity differ
based on serum markers of the insulin-like growth factor 1 (IGF-1) pathway in patients with
newly diagnosed metastatic Ewing sarcoma treated with interval compressed chemotherapy with
and without the addition of ganitumab.

VI. To determine if EFS, overall survival, and bone marrow response rates differ based on
protein, deoxyribose nucleic acid (DNA), and ribonucleic acid (RNA) marker in patients with
newly diagnosed metastatic Ewing sarcoma treated with interval compressed chemotherapy with
and without the addition of ganitumab.

VII. To evaluate bone marrow micrometastatic disease and tumor cell surface IGF-1R expression
at diagnosis and after 3 and 6 cycles of study therapy in patients with newly diagnosed
metastatic Ewing sarcoma.

VIII. To determine if the presence of germline polymorphisms in EGFR correlate with response
to multiagent therapy with and without ganitumab.

IX. To investigate the ability of fludeoxyglucose F 18-positron emission tomography (FDG-PET)
to augment conventional response assessment of primary Ewing sarcoma tumors by magnetic
resonance imaging (MRI).

X. To explore FDG-PET response at the primary tumor as a prognostic marker and as a
predictive biomarker of clinical activity of IGF-1R inhibition in patients with newly
diagnosed metastatic Ewing sarcoma.

XI. To collect data on institutional testing for Ewing sarcoma breakpoint region 1 (EWSR1)
translocation status in patients enrolling on study.

XII. To explore the capacity of plasma cell-free DNA analysis to detect tumor-specific
genetic changes at initial diagnosis and after initiation of protocol therapy.

XIII. To collect a population of bone marrow metastatic tumor cells by flow cytometry for
genomic profiling.

OUTLINE: Patients are randomized to 1 of 2 treatment regimens.

REGIMEN A (vincristine sulfate, doxorubicin hydrochloride and cyclophosphamide [VDC] and
ifosfamide and etoposide [IE]):

INDUCTION THERAPY: Patients receive vincristine sulfate intravenously (IV) over 1 minute on
day 1; doxorubicin hydrochloride IV over 1-15 minutes on days 1 and 2; and cyclophosphamide
IV over 30-60 minutes on day 1 of weeks 1, 5, and 9; and ifosfamide IV over 1 hour on days 1
to 5 and etoposide IV over 1-2 hours on days 1 to 5 of weeks 3, 7, and 11.

LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation
therapy.

CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV over 1 minute on day 1 of
weeks 1, 7, 9, and 13; doxorubicin hydrochloride IV over 1-15 minutes on days 1 and 2 of
weeks 1 and 7; cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 7, 9, and 13;
ifosfamide IV over 1 hour on days 1 to 5 of weeks 3, 5, 11, and 15; and etoposide IV over 1-2
hours on days 1 to 5 of weeks 3, 5, 11, and 15.

METASTATIC SITE IRRADIATION: Patients with lung metastases undergo definitive SBRT or
external beam radiation therapy (EBRT) over 5 days.

REGIMEN B (VDC/IE + ganitumab):

INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab
IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11.

LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation
therapy.

CONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and ganitumab
IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15.

METASTATIC SITE IRRADIATION: Patients with lung metastases undergo definitive SBRT or EBRT
over 5 days.

MAINTENANCE THERAPY: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes on
day 1 in weeks 1, 4, 7, 10, 13, 16, 19, and 22.

After completion of study treatment, patients are followed for 10 years.

Inclusion Criteria:

- Patients with histologic diagnosis (by institutional pathologist) of newly diagnosed
Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) arising from bone
or soft tissue and with metastatic disease involving lung, bone, bone marrow, or other
metastatic site

- For the purpose of this study metastatic disease is defined as one or more of the
following:

- Lesions which are discontinuous from the primary tumor, are not regional lymph
nodes, and do not share a bone or body cavity with the primary tumor; skip
lesions in the same bone as the primary tumor do not constitute metastatic
disease; skip lesions in an adjacent bone are considered bone metastases; if
there is any doubt whether lesions are metastatic, a biopsy of those lesions
should be performed

- Contralateral pleural effusion and/or contralateral pleural nodules

- Distant lymph node involvement

- Patients with pulmonary nodules are considered to have metastatic disease if the
patient has:

- Solitary nodule >= 0.5 cm or multiple nodules of >= 0.3 cm unless lesion is
biopsied and negative for tumor

- Patients with solitary nodule < 0.5 cm or multiple nodules < 0.3 cm are not
considered to have lung metastasis unless biopsy documents tumor

- Bone marrow metastatic disease is based on morphologic evidence of Ewing sarcoma
based on hematoxylin and eosin (H&E) stains; in the absence of morphologic
evidence of marrow involvement on H&E, patients with bone marrow involvement
detected ONLY by flow cytometry, reverse-transcriptase (RT)-polymerase chain
reaction (PCR), fluorescence in situ hybridization (FISH), or
immunohistochemistry will NOT be considered to have clinical bone marrow
involvement for the purposes of this study

- This study requires bilateral bone marrow biopsies at study entry; the
suggested approach for patients with large pelvic tumors in which a
posterior iliac crest bone marrow biopsy would track through the tumor is to
instead undergo 2 marrow biopsies on the contralateral side (either 2
posterior biopsies or one posterior and one anterior biopsy)

- Bone metastasis: This study utilizes whole body FDG-PET scans to screen patients
for bone metastases; areas suspicious for bone metastasis based on FDG-PET scans
require confirmatory anatomic imaging with either MRI or computed tomography (CT)
(whole body FDG-PET/CT or FDG-PET/magnetic resonance [MR] scan acceptable); whole
body technetium bone scans may be performed at the discretion of the investigator
and are not required; for patients without other sites of metastatic disease
whose sole metastatic site to qualify for study entry is a single area suspicious
for bone metastasis identified by FDG-PET, confirmatory biopsy or anatomic
imaging evidence of an associated soft tissue mass at that site is required for
study entry

- Patients must have adequate tumor tissue to meet the minimum requirement for
submission

- Enrolling institutions are reminded that submission of pre-treatment serum, tumor
tissue and whole blood is required

- Patients should only have had a biopsy of the primary tumor without an attempt at
complete or partial resection; patients will still be eligible if excision was
attempted or accomplished as long as adequate anatomic imaging (MRI for most primary
tumor sites) was obtained prior to surgery

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:

- Age < 6 months: Maximum serum creatinine (mg/dL): 0.4 for males and females

- Age 6 months to < 1 year: Maximum serum creatinine (mg/dL): 0.5 for males and
females

- Age 1 to < 2 years: Maximum serum creatinine (mg/dL): 0.6 for males and females

- Age 2 to < 6 years: Maximum serum creatinine (mg/dL): 0.8 for males and females

- Age 6 to < 10 years: Maximum serum creatinine (mg/dL): 1 for males and females

- Age 10 to < 13 years: Maximum serum creatinine (mg/dL): 1.2 for males and females

- Age 13 to < 16 years: Maximum serum creatinine (mg/dL): 1.5 for males and 1.4 for
females

- Age >= 16 years: Maximum serum creatinine (mg/dL): 1.7 for males and 1.4 for
females

- Total bilirubin =< 1.5 x upper limit of normal (ULN) for age, and

- Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 3 x
upper limit of normal (ULN) for age (except for patients with liver metastasis who may
enroll if ALT < 5 times ULN for age)

- Shortening fraction of >= 27% or

- Ejection fraction of >= 50%

- Patients must have a normal blood sugar level for age to participate; if an initial
random draw (ie. non-fasting) blood glucose value is out of range, it is acceptable to
repeat this test as a fasting draw

- All patients and/or their parents or legal guardians must sign a written informed
consent

- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met

Exclusion Criteria:

- Patients with regional node involvement as their only site of disease beyond the
primary tumor will not be eligible

- Patients whose primary tumors arise in the intra-dural soft tissue (eg. brain and
spinal cord) are not eligible

- Patients who have received prior chemotherapy or radiation therapy are not eligible

- Female patients of childbearing potential are not eligible unless a negative pregnancy
test result has been obtained; lactating females are not eligible unless they have
agreed not to breastfeed their infants for the duration of protocol therapy; sexually
active patients of reproductive potential are not eligible unless they have agreed to
use an effective contraceptive method for the duration of protocol therapy

- Patients with known pre-existing diabetes mellitus will be excluded from study

- Patients receiving chronic pharmacologic doses of corticosteroids are not eligible;
for the purposes of eligibility, chronic exposure is defined as anticipated exposure
of > 3 weeks, including the sum of both pre-enrollment and anticipated post-enrollment
dosing; patients on acute corticosteroid therapy (=< 3 weeks of total planned
exposure) must still meet the normal blood glucose requirement; patients receiving
chronic inhaled corticosteroids or chronic physiologic replacement doses of
corticosteroids are eligible
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489 State St
Bangor, Maine 04401
(207) 973-7000
Principal Investigator: Nadine P. SantaCruz
Phone: 207-973-4274
Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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4305 New Shepherdsville Road
Bardstown, Kentucky 40004
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
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Bardstown, KY
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265 Fremont St
Battle Creek, Michigan 49017
(269) 245-8166
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
Bronson Battle Creek As a proud member of the Battle Creek community, we believe everyone...
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2500 Bellevue Medical Center Drive
Bellevue, Nebraska 68123
Principal Investigator: Minnie Abromowitch
Phone: 402-559-6941
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Berlin, Vermont 05602
Principal Investigator: Jessica L. Heath
Phone: 802-225-5400
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Berlin, VT
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8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Principal Investigator: Kenneth Lieuw
Phone: 301-319-2100
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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100 E Idaho St
Boise, Idaho 83712
(208) 381-2711
Principal Investigator: Eugenia Chang
Phone: 208-381-3376
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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Boise, ID
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Bolivar, Missouri 65613
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55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Principal Investigator: Steven G. DuBois
Phone: 877-726-5130
Massachusetts General Hospital Cancer Center An integral part of one of the world
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Steven G. DuBois
Phone: 877-442-3324
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Branson, Missouri 65616
Principal Investigator: Jay W. Carlson
Phone: 417-269-4520
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Branson, MO
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Bremerton, Washington 98310
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
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Bronx, New York 10461
Principal Investigator: Lisa Gennarini
Phone: 718-379-6866
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Bronx, New York 10461
Principal Investigator: Lisa Gennarini
Phone: 718-379-6866
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Bronx, New York 10467
Principal Investigator: Lisa Gennarini
Phone: 718-379-6866
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Bronx, New York 10467
Principal Investigator: Lisa Gennarini
Phone: 888-823-5923
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Bryan, Texas 77802
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
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Burien, Washington 98166
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
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Burien, WA
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Burlington, Vermont 05405
Principal Investigator: Jessica L. Heath
Phone: 802-656-4101
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Calgary, Alberta
Principal Investigator: Douglas R. Strother
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Carson City, Nevada 89703
Principal Investigator: Alan K. Ikeda
Phone: 702-384-0013
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Chapel Hill, North Carolina 27599
Principal Investigator: Stuart H. Gold
Phone: 877-668-0683
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Jacqueline M. Kraveka
Phone: 843-792-9321
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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Charlotte, North Carolina 28204
Principal Investigator: Joel A. Kaplan
Phone: 800-804-9376
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Chattanooga, Tennessee 37403
Principal Investigator: Manoo G. Bhakta
Phone: 865-331-1812
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Chattanooga, Tennessee 37404
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
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Chicago, Illinois 60614
Principal Investigator: David O. Walterhouse
Phone: 773-880-4562
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1200 West Harrison Stree
Chicago, Illinois 60607
(312) 996-4350
Principal Investigator: Mary L. Schmidt
Phone: 312-355-3046
Univ of Illinois A major research university in the heart of one of the world's...
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
Principal Investigator: Susan L. Cohn
Phone: 773-702-8222
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
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Cincinnati, Ohio 45220
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
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Cincinnati, Ohio 45242
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
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Cincinnati, Ohio 45247
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
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Cincinnati, Ohio 45255
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Rabi Hanna
Phone: 866-223-8100
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Clive, Iowa 50325
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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12495 University Ave
Clive, Iowa 50325
(515) 358-9700
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
Mercy Cancer Center - West Lakes When it comes to cancer care, there
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6001 E Woodmen Rd
Colorado Springs, Colorado 80923
(719) 776-5000
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
Penrose-Saint Francis Healthcare Founded by the Sisters of St. Francis and the Sisters of Charity,...
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Colorado Springs, CO
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Colorado Springs, Colorado 80907
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
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Columbia, Missouri 65201
Principal Investigator: Thomas W. Loew
Phone: 573-882-7440
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5 Richland Medical Park Dr
Columbia, South Carolina 29203
(803) 434-7000
Principal Investigator: Stuart L. Cramer
Phone: 803-434-3680
Palmetto Health Richland Palmetto Health Richland, originally founded in 1892 as Columbia Hospital, has a...
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Corbin, Kentucky 40701
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
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Council Bluffs, Iowa 51503
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
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Creston, Iowa 50801
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
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Dallas, Texas 75390
Principal Investigator: Patrick J. Leavey
Phone: 214-648-7097
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Danville, Illinois 61832
Principal Investigator: Yujie Zhao
Phone: 800-446-5532
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