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Dinaciclib in Treating Patients With Stage IV Melanoma
Study Purpose
This phase II trial is studying the side effects and how well dinaciclib works in treating patients with stage IV melanoma. Dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
Inclusion Criteria:
- - Biopsy-confirmed malignant melanoma.
- - Stage IV disease.
- - Cutaneous or mucosal origin.
- - Melanoma of unknown primary allowed.
- - No ocular melanoma.
- - Measurable or non-measurable disease.
- - No prior or concurrent brain metastases as confirmed by CT scan or MRI.
- - Zubrod performance status 0-1.
- - ANC ≥ 1,500/mm^3.
- - Platelet count ≥ 100,000/mm^3.
- - Hemoglobin ≥ 9 g/dL.
- - Serum bilirubin ≤ 1.5 times upper limit of normal (ULN) (including patients with hepatic metastases) - SGOT or SGPT ≤ 2.5 times ULN (≤ 5 times ULN in the presence of hepatic metastases) - Serum creatinine ≤ 1.5 times ULN.
- - Not pregnant or nursing.
- - Fertile patients must use effective contraception.
- - No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.
- - No prior therapy with a cyclin-dependent kinase inhibitor.
- - At least 14 days since prior radiotherapy.
- - At least 28 days since prior systemic chemotherapy.
- - At least 28 days since prior adjuvant systemic therapy.
- - At least 28 days since prior surgery.
- - No more than 1 prior systemic therapy regimen (chemotherapy, biologic/immunotherapy, hormonal therapy, or a combination regimen) for stage IV melanoma and any side effects must have resolved to ≤ grade 1.
- - Any number of prior adjuvant systemic therapy regimens allowed, including interferon alfa-2b, GM-CSF, chemotherapy, and chemobiotherapy.
- - Therapy for stage IV resected free-of-disease will be considered adjuvant therapy.
- - Prior radiotherapy allowed provided any side effects have resolved to ≤ grade 1.
- - Prior surgery (for both the primary and stage IV disease) allowed provided side effects have resolved to ≤ grade 1.
- - No other concurrent or planned non-study treatment (including chemotherapy, hormonal therapy, biologic therapy, or radiotherapy) - No concurrent CYP3A4 inhibitors or inducers.
Trial Details
|
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT00937937 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
National Cancer Institute (NCI) |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Christopher D Lao |
| Principal Investigator Affiliation | SWOG Cancer Research Network |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
NIH |
| Overall Status | Active, not recruiting |
| Countries | United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Acral Lentiginous Melanoma, Cutaneous Nodular Melanoma, Lentigo Maligna Melanoma, Low-CSD Melanoma, Mucosal Melanoma, Recurrent Melanoma, Stage IV Cutaneous Melanoma AJCC v6 and v7 |
PRIMARY OBJECTIVES:
- I. To assess the 1-year overall survival rate in patients with stage IV melanoma treated with dinaciclib.
- I. To assess the 6-month progression-free survival rate in these patients.
- II. To evaluate the response rate (confirmed and unconfirmed complete and partial responses) in the subset of patients with measurable disease.
- III. To assess the safety and tolerability of dinaciclib given to patients with stage IV melanoma.
Arms
Experimental: Arm I
Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions
Drug: - Dinaciclib
Given IV
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Address
Providence Hospital
Mobile, Alabama, 36608
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Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
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Highlands Oncology Group - Rogers
Rogers, Arkansas, 72758
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East Bay Radiation Oncology Center
Castro Valley, California, 94546
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Eden Hospital Medical Center
Castro Valley, California, 94546
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Address
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, 94546
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Bay Area Breast Surgeons Inc
Emeryville, California, 94608
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Address
Valley Medical Oncology Consultants-Fremont
Fremont, California, 94538
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Address
Contra Costa Regional Medical Center
Martinez, California, 94553-3156
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El Camino Hospital
Mountain View, California, 94040
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Highland General Hospital
Oakland, California, 94602
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Alta Bates Summit Medical Center - Summit Campus
Oakland, California, 94609
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Bay Area Tumor Institute
Oakland, California, 94609
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Address
Hematology and Oncology Associates-Oakland
Oakland, California, 94609
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Address
Tom K Lee Inc
Oakland, California, 94609
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Address
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
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Valley Care Health System - Pleasanton
Pleasanton, California, 94588
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Valley Medical Oncology Consultants
Pleasanton, California, 94588
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Address
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, 94806
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Address
Poudre Valley Hospital
Fort Collins, Colorado, 80524
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Address
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105
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Address
Boca Raton Comprehensive Cancer Center
Boca Raton, Florida, 33486
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Orlando Health Cancer Institute
Orlando, Florida, 32806
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Memorial Health University Medical Center
Savannah, Georgia, 31404
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Address
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405
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South Georgia Medical Center/Pearlman Cancer Center
Valdosta, Georgia, 31602
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Address
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
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Address
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
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Address
Decatur Memorial Hospital
Decatur, Illinois, 62526
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Address
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
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Loyola University Medical Center
Maywood, Illinois, 60153
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SSM Health Good Samaritan
Mount Vernon, Illinois, 62864
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Springfield Memorial Hospital
Springfield, Illinois, 62781
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Address
Franciscan Saint Francis Health-Beech Grove
Beech Grove, Indiana, 46107
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Reid Health
Richmond, Indiana, 47374
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Address
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720
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Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801
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Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042
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Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701
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HaysMed
Hays, Kansas, 67601
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Address
Hutchinson Regional Medical Center
Hutchinson, Kansas, 67502
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Cancer Center of Kansas-Independence
Independence, Kansas, 67301
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Address
University of Kansas Cancer Center
Kansas City, Kansas, 66160
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Address
Cancer Center of Kansas-Kingman
Kingman, Kansas, 67068
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Lawrence Memorial Hospital
Lawrence, Kansas, 66044
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Address
Southwest Medical Center
Liberal, Kansas, 67901
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Address
Cancer Center of Kansas-Liberal
Liberal, Kansas, 67905
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Address
Cancer Center of Kansas - Newton
Newton, Kansas, 67114
Status
Address
Olathe Cancer Center
Olathe, Kansas, 66061
Status
Address
Menorah Medical Center
Overland Park, Kansas, 66209
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Address
Saint Luke's South Hospital
Overland Park, Kansas, 66213
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Address
Cancer Center of Kansas - Parsons
Parsons, Kansas, 67357
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Address
Mercy Hospital Pittsburg
Pittsburg, Kansas, 66762
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Address
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, 66208
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Address
Cancer Center of Kansas - Pratt
Pratt, Kansas, 67124
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Address
Cancer Center of Kansas - Salina
Salina, Kansas, 67401
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Address
Salina Regional Health Center
Salina, Kansas, 67401
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Address
AdventHealth Shawnee Mission
Shawnee Mission, Kansas, 66204
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Address
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka, Kansas, 66606
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Address
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, 66606
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Address
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152
Status
Address
Associates In Womens Health
Wichita, Kansas, 67208
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Address
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208
Status
Address
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214
Status
Address
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214
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Address
Wichita NCI Community Oncology Research Program
Wichita, Kansas, 67214
Status
Address
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156
Status
Address
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70806
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Address
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
Status
Address
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112
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Address
University Medical Center New Orleans
New Orleans, Louisiana, 70112
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Address
Boston Medical Center
Boston, Massachusetts, 02118
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Address
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, 48106
Status
Address
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
Status
Address
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
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Address
Bronson Battle Creek
Battle Creek, Michigan, 49017
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Address
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, 49307
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Address
Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124
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Address
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
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Address
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236
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Address
Hurley Medical Center
Flint, Michigan, 48503
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Address
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, 48532
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Address
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, 49503
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Address
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
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Address
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
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Address
Allegiance Health
Jackson, Michigan, 49201
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Address
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
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Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
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Address
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444
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Address
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
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Address
Lake Huron Medical Center
Port Huron, Michigan, 48060
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Address
MyMichigan Medical Center Saginaw
Saginaw, Michigan, 48601
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Address
Munson Medical Center
Traverse City, Michigan, 49684
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Address
Henry Ford Health Warren Hospital
Warren, Michigan, 48093
Status
Address
University of Michigan Health - West
Wyoming, Michigan, 49519
Status
Address
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Status
Address
University Health Truman Medical Center
Kansas City, Missouri, 64108
Status
Address
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Status
Address
Saint Joseph Health Center
Kansas City, Missouri, 64114
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Address
North Kansas City Hospital
Kansas City, Missouri, 64116
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Address
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, 64118
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Address
Research Medical Center
Kansas City, Missouri, 64132
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Address
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, 64086
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Address
Liberty Hospital
Liberty, Missouri, 64068
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Address
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506
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Address
Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri, 63109
Status
Address
Mercy Hospital Saint Louis
Saint Louis, Missouri, 63141
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Address
Saint Louis-Cape Girardeau CCOP
Saint Louis, Missouri, 63141
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Address
Billings Clinic Cancer Center
Billings, Montana, 59101
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Address
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101
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Address
Saint Vincent Healthcare
Billings, Montana, 59101
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Address
Montana Cancer Consortium NCORP
Billings, Montana, 59102
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Address
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102
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Address
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
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Address
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701
Status
Address
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Status
Address
Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, 59405
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Address
Great Falls Clinic
Great Falls, Montana, 59405
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Address
Northern Montana Hospital
Havre, Montana, 59501
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Address
Saint Peter's Community Hospital
Helena, Montana, 59601
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Address
Glacier Oncology PLLC
Kalispell, Montana, 59901
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Address
Kalispell Medical Oncology
Kalispell, Montana, 59901
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Address
Logan Health Medical Center
Kalispell, Montana, 59901
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Address
Montana Cancer Specialists
Missoula, Montana, 59802
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Address
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802
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Address
Community Medical Center
Missoula, Montana, 59804
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Address
Guardian Oncology and Center for Wellness
Missoula, Montana, 59804
Status
Address
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
Status
Address
Nevada Cancer Institute-Summerlin Campus
Las Vegas, Nevada, 89135
Status
Address
University of Rochester
Rochester, New York, 14642
Status
Address
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
Status
Address
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534
Status
Address
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374
Status
Address
Southeast Clinical Oncology Research Consortium NCORP
Winston-Salem, North Carolina, 27104
Status
Address
Grandview Hospital
Dayton, Ohio, 45405
Status
Address
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406
Status
Address
Miami Valley Hospital
Dayton, Ohio, 45409
Status
Address
Miami Valley Hospital North
Dayton, Ohio, 45415
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Address
Dayton NCI Community Oncology Research Program
Dayton, Ohio, 45459
Status
Address
Blanchard Valley Hospital
Findlay, Ohio, 45840
Status
Address
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
Status
Address
Wayne Hospital
Greenville, Ohio, 45331
Status
Address
Kettering Medical Center
Kettering, Ohio, 45429
Status
Address
Upper Valley Medical Center
Troy, Ohio, 45373
Status
Address
Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center
Wilmington, Ohio, 45177
Status
Address
Greene Memorial Hospital
Xenia, Ohio, 45385
Status
Address
Saint Charles Health System
Bend, Oregon, 97701
Status
Address
Providence Milwaukie Hospital
Milwaukie, Oregon, 97222
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Address
Providence Portland Medical Center
Portland, Oregon, 97213
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Address
Adventist Medical Center
Portland, Oregon, 97216
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Address
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
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Address
Salem Hospital
Salem, Oregon, 97301
Status
Address
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
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Address
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
Status
Address
McLeod Regional Medical Center
Florence, South Carolina, 29506
Status
Address
Greenville Health System Cancer Institute-Andrews
Greenville, South Carolina, 29601
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Address
Saint Francis Hospital
Greenville, South Carolina, 29601
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Address
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
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Address
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
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Address
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
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Address
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
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Address
Self Regional Healthcare
Greenwood, South Carolina, 29646
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Address
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
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Address
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672
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Address
Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee, 37660
Status
Address
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916
Status
Address
Medical City Dallas Hospital
Dallas, Texas, 75230
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Address
Scott and White Memorial Hospital
Temple, Texas, 76508
Status
Address
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
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Address
Danville Regional Medical Center
Danville, Virginia, 24541
Status
Address
Sovah Health Martinsville
Martinsville, Virginia, 24112
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Address
Ballad Health Cancer Care - Norton
Norton, Virginia, 24273
Status
Address
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Status
Address
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
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Address
Skagit Valley Hospital
Mount Vernon, Washington, 98274
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Address
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, 98370
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Address
Harborview Medical Center
Seattle, Washington, 98104
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Address
Minor and James Medical PLLC
Seattle, Washington, 98104
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Address
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
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Address
Kaiser Permanente Washington
Seattle, Washington, 98112
Status
Address
Swedish Medical Center-First Hill
Seattle, Washington, 98122
Status
Address
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
Status
Address
Saint Michael Cancer Center
Silverdale, Washington, 98383
Status
Address
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202
Status
Address
Evergreen Hematology and Oncology PS
Spokane, Washington, 99218
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Address
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664
Status
Address
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, 98801
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Address
Rocky Mountain Oncology
Casper, Wyoming, 82609
Status
Address
Welch Cancer Center
Sheridan, Wyoming, 82801
