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Kidney CancerPhase 2NCT00039429

Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer

A Phase 2 study testing atrasentan hydrochloride in people with Kidney Cancer, run by Eastern Cooperative Oncology Group at 177 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well atrasentan works in treating patients with locally recurrent or metastatic kidney cancer. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Kidney Cancer
What is being tested?
atrasentan hydrochloride
How many people
180 participants
Where
177 sitesUnited States
Study dates
14 Jul 2003to Apr 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed locally recurrent or metastatic renal cell carcinoma that is not amenable to resection
  • Progressive disease, defined by 1 of the following:
  • The appearance of 1 or more new lesions
  • At least a 20% increase in the sum of the longest diameters of the target lesions (taking as a reference the smallest sum of the longest diameters recorded since the baseline measurements) (measurable disease stratum closed to accrual as of 7/16/04.)
  • One of the following disease characteristics:
  • Disease manifested solely by bone metastases
  • At least 1 measurable lesion (measurable disease stratum closed to accrual as of 7/16/04.)
  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • No prior or concurrent brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 2,000/mm^3 OR
  • Absolute neutrophil count greater than 1,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL

Hepatic:

  • Bilirubin less than 1.5 mg/dL
  • AST and/or ALT less than 1.5 times upper limit of normal (ULN)

Renal:

  • Creatinine less than 1.5 times ULN

Cardiovascular:

  • No history of New York Heart Association class II-IV heart disease

Pulmonary:

  • No significant pulmonary disease requiring pulse steroid therapy within the past 3 months

Other:

  • No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No other serious concurrent medical illness that would preclude study participation
  • No active infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior biologic therapy/immunotherapy and recovered
  • No more than 1 prior regimen* of biologic therapy/immunotherapy (e.g., interleukin-2, interferon, thalidomide, or combination)
  • Prior sargramostim (GM-CSF) is not counted as prior biological therapy NOTE: *A regimen is considered to be at least 4 weeks of treatment

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • At least 4 weeks since prior hormonal agents (e.g., megestrol or tamoxifen) and recovered

Radiotherapy:

  • At least 4 weeks since prior radiotherapy and recovered
  • Prior radiotherapy for local control or palliation of painful bony lesion allowed
  • No prior radiotherapy to target lesions
  • No concurrent radiotherapy for palliation or any other indication

Surgery:

  • At least 4 weeks since prior surgery and recovered
  • Prior nephrectomy allowed

Other:

  • Prior bisphosphonates allowed

Trial locations and contacts

177 sites in 1 country.

177 sites in 1 country

United States177 sites

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • Cancer Care Institute of Carolina at Aiken Regional Medical Centers

    Aiken, South Carolina, 29801

  • Akron City Hospital

    Akron, Ohio, 44309-2090

  • McFarland Clinic, P. C.

    Ames, Iowa, 50010

  • St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Northeast Georgia Cancer Care, LLC

    Athens, Georgia, 30607

  • Veterans Affairs Medical Center - Augusta

    Augusta, Georgia, 30904

  • MBCCOP-Medical College of Georgia Cancer Center

    Augusta, Georgia, 30912

  • Aurora Presbyterian Hospital

    Aurora, Colorado, 80012

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60507

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • Pennington Cancer Center at Baton Rouge General

    Baton Rouge, Louisiana, 70806

  • Mary Bird Perkins Cancer Center - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • MeritCare Clinic - Bemidji

    Bemidji, Minnesota, 56601

  • St. Luke's Hospital Cancer Center

    Bethlehem, Pennsylvania, 18015

  • Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center

    Boca Raton, Florida, 33486

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Boulder Community Hospital

    Boulder, Colorado, 80301-9019

  • Wood County Oncology Center

    Bowling Green, Ohio, 43402

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Mercy Cancer Center at Mercy Medical Center

    Canton, Ohio, 44708

  • Aultman Hospital Cancer Center at Aultman Health Foundation

    Canton, Ohio, 44710-1799

  • St. Luke's Hospital

    Cedar Rapids, Iowa, 52402

  • Cedar Rapids Oncology Associates

    Cedar Rapids, Iowa, 52403

  • Mercy Regional Cancer Center at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division

    Charleston, West Virginia, 25304

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • Hematology and Oncology Associates

    Chicago, Illinois, 60611

  • Veterans Affairs Medical Center - Lakeside Chicago

    Chicago, Illinois, 60611

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612-7243

  • Veterans Affairs Medical Center - Chicago Westside Hospital

    Chicago, Illinois, 60612

  • Mercy Hospital and Medical Center

    Chicago, Illinois, 60616

  • Swedish Covenant Hospital

    Chicago, Illinois, 60625

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • MetroHealth's Cancer Care Center at MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Penrose Cancer Center at Penrose Hospital

    Colorado Springs, Colorado, 80933

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Riverside Cancer Services

    Columbus, Ohio, 43215

  • Mount Carmel West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-0001

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Presbyterian - St. Luke's Medical Center

    Denver, Colorado, 80218

  • St. Joseph Hospital

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • CCOP - Colorado Cancer Research Program, Incorporated

    Denver, Colorado, 80224-2522

  • Mercy Capitol Hospital

    Des Moines, Iowa, 50307

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at Mercy Cancer Center

    Des Moines, Iowa, 50314

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • John Stoddard Cancer Center at Iowa Lutheran Hospital

    Des Moines, Iowa, 50316-2301

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Miller-Dwan Medical Center

    Duluth, Minnesota, 55805

  • St. Mary's - Duluth Clinic Cancer Center

    Duluth, Minnesota, 55805

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Elmhurst Memorial Hospital

    Elmhurst, Illinois, 60126

  • Swedish Medical Center

    Englewood, Colorado, 80110

  • CCOP - MeritCare Hospital

    Fargo, North Dakota, 58122

  • MeritCare Medical Group

    Fargo, North Dakota, 58122

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Hunterdon Regional Cancer Center at Hunterdon Medical Center

    Flemington, New Jersey, 08822

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Fremont Memorial Hospital

    Fremont, Ohio, 43420

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Green Bay Oncology, Limited at St. Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • Green Bay Oncology, Limited at St. Mary's Hospital

    Green Bay, Wisconsin, 54303

  • St. Mary's Hospital Medical Center - Green Bay

    Green Bay, Wisconsin, 54303

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Cancer Institute of New Jersey at Hamilton

    Hamilton, New Jersey, 08690

  • PinnacleHealth Regional Cancer Center at Polyclinic Hospital

    Harrisburg, Pennsylvania, 17105

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Hinsdale Hematology Oncology Associates

    Hinsdale, Illinois, 60521

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Midwest Center for Hematology/Oncology

    Joliet, Illinois, 60432

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Lakeland Regional Cancer Center at Lakeland Regional Medical Center

    Lakeland, Florida, 33805

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Central Pennsylvania Hematology and Medical Oncology Associates, P. C.

    Lemoyne, Pennsylvania, 17043

  • Lewistown Hospital

    Lewistown, Pennsylvania, 17044

  • North Shore Oncology and Hematology Associates, Limited - Libertyville

    Libertyville, Illinois, 60048

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Bryan LGH Medical Center West

    Lincoln, Nebraska, 68502

  • Cancer Resource Center - Lincoln

    Lincoln, Nebraska, 68510

  • St. Elizabeth Regional Medical Center

    Lincoln, Nebraska, 68510

  • Meeker County Memorial Hospital

    Litchfield, Minnesota, 55355

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Hope Cancer Care Center at Longmont United Hospital

    Longmont, Colorado, 80502

  • Medical Center of Central Georgia

    Macon, Georgia, 31208

  • Dean Medical Center - Fish Hatchery

    Madison, Wisconsin, 53715

  • HealthEast Cancer Care at St. John's Hospital

    Maplewood, Minnesota, 55109

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Bay Area Cancer Care Center at Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Marshfield Clinic - Marshfield Center

    Marshfield, Wisconsin, 54449

  • Mercy Cancer Center at Mercy Medical Center - North Iowa

    Mason City, Iowa, 50401

  • St. Luke's Hospital

    Maumee, Ohio, 43537

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • Trinity Medical Center - East

    Moline, Illinois, 61265

  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08903

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Medical Center of Louisiana - New Orleans

    New Orleans, Louisiana, 70112

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio, 43055

  • Northwest Medical Specialist, PC

    Niles, Illinois, 60714

  • St. Charles Mercy Hospital

    Oregon, Ohio, 43616

  • Joan Karnell Cancer Center at Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107

  • St. Mary-Corwin Regional Medical Center

    Pueblo, Colorado, 81004

  • All Saints Cancer Center at All Saints Medical Center

    Racine, Wisconsin, 53405

  • Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • Hubert H. Humphrey Cancer Center at North Memorial Medical Center

    Robbinsdale, Minnesota, 55422-2900

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Swedish-American Regional Cancer Center

    Rockford, Illinois, 61104-2315

  • Seton Cancer Institute - Saginaw

    Saginaw, Michigan, 48601

  • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph

    Saint Joseph, Michigan, 49085

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Health Services

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital Cancer Care Center

    Saint Paul, Minnesota, 55101

  • St. Joseph's Hospital

    Saint Paul, Minnesota, 55102

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Firelands Regional Medical Center

    Sandusky, Ohio, 44870

  • Guthrie Medical Center - Sayre

    Sayre, Pennsylvania, 18840

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259

  • Saint Francis Cancer Center

    Shakopee, Minnesota, 55379

  • Siouxland Hematology-Oncology Associates

    Sioux City, Iowa, 51101

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa, 51104

  • St. Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Sioux Valley Hospital and University of South Dakota Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • Hematology Oncology Associates - Skokie

    Skokie, Illinois, 60076

  • Hematology/Oncology of the North Shore at Gross Point Medical Center

    Skokie, Illinois, 60076

  • Midwest Cancer Research Group, Incorporated

    Skokie, Illinois, 60077

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Saint Joseph Regional Medical Center

    South Bend, Indiana, 46617

  • Regional Cancer Center at Memorial Medical Center

    Springfield, Illinois, 62781

  • Mercy Medical Center

    Springfield, Ohio, 45504

  • Community Hospital of Springfield and Clark County

    Springfield, Ohio, 45505

  • Geisinger Medical Group

    State College, Pennsylvania, 16801

  • Mount Nittany Medical Center

    State College, Pennsylvania, 16803

  • Stony Brook University Cancer Center

    Stony Brook, New York, 11794-8174

  • Promedica Cancer Center at Flower Hospital

    Sylvania, Ohio, 43560

  • Albert Einstein Cancer Center at Albert Einstein College of Medicine

    The Bronx, New York, 10461

  • Our Lady of Mercy Medical Center Comprehensive Cancer Center

    The Bronx, New York, 10466

  • North Suburban Medical Center

    Thornton, Colorado, 80229

  • Toledo Hospital

    Toledo, Ohio, 43606

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • Medical University of Ohio Cancer Center

    Toledo, Ohio, 43614

  • CCOP - Toledo Community Hospital

    Toledo, Ohio, 43623

  • Toledo Clinic, Incorporated - Main Clinic

    Toledo, Ohio, 43623

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois, 61801

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • Fulton County Health Center

    Wauseon, Ohio, 43567

  • Chester County Hospital

    West Chester, Pennsylvania, 19380

  • Medical Oncology and Hematology Associates - West Des Moines

    West Des Moines, Iowa, 50266

  • Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital

    Westerville, Ohio, 43081

  • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania, 18711

  • York Cancer Center at Wellspan Health

    York, Pennsylvania, 17403

  • Genesis - Good Samaritan Hospital

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: A Phase II Trial Evaluating Atrasentan In Patients With Advanced Renal Cell Carcinoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well atrasentan works in treating patients with locally recurrent or metastatic kidney cancer.

Read the detailed description

OBJECTIVES:

  • Determine the 6-month progression-free survival rate, in terms of proportion of those with measurable disease or bone metastases only, of patients with locally recurrent or metastatic renal cell carcinoma treated with atrasentan (measurable disease stratum closed to accrual as of 7/16/04).
  • Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior immunotherapy/biologic therapy (yes vs no) and characteristic of disease (measurable vs bone metastases only) (measurable disease stratum closed to accrual as of 7/16/04).

Patients receive oral atrasentan once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 180 patients (90 per stratum [with or without prior therapy]) will be accrued for this study within 6 months (based on prior accrual, the bone metastases only group [specifically patients who have received 1 prior therapy] is the only stratum open for accrual).

Conditions
Kidney Cancer
Being tested
atrasentan hydrochloride
Keywords
stage IV renal cell cancer, recurrent renal cell cancer
Medical subject headings
Kidney Neoplasms, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • atrasentan hydrochlorideDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival at 6 months

  2. Toxicity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study start14 Jul 2003
  3. Primary completionApr 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00039429
Sponsor's protocol ID
CDR0000069382
Other IDs
E6800
Status last verified
Jun 2023
First submitted
6 Jun 2002
Last updated
22 Jun 2023
Results posted
No
Data monitoring committee
No

Publications

  • Manola J, Carducci M, Nair S, et al.: Phase II ECOG trial of atrasentan in advanced renal cell carcinoma. [Abstract] J Clin Oncol 25 (Suppl 18): A-5102, 260s, 2007.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing atrasentan hydrochloride in people with Kidney Cancer, run by Eastern Cooperative Oncology Group at 177 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 177 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival at 6 months. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00039429, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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