Vemurafenib and Cobimetinib in Treating Patients With BRAF V600E Mutation Positive Craniopharyngioma
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/7/2019 |
Start Date: | August 4, 2017 |
End Date: | August 2026 |
Contact: | Priscilla K. Brastianos, MD |
Email: | pbrastianos@partners.org |
Phone: | 617-643-1938 |
Phase II Trial of BRAF/MEK Inhibitors in Papillary Craniopharyngiomas
This phase II trial studies how well vemurafenib and cobimetinib work in treating patients
with BRAF V600E mutation positive craniopharyngioma. Vemurafenib and cobimetinib may stop the
growth of tumor cells by blocking some of the enzymes needed for cell growth.
with BRAF V600E mutation positive craniopharyngioma. Vemurafenib and cobimetinib may stop the
growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To determine the activity of BRAF and MEK inhibitor combination in untreated papillary
craniopharyngiomas as measured by best response at any time during the first four cycles of
BRAF and MEK inhibitor treatment.
II. To determine the activity of BRAF and MEK inhibitor combination in papillary
craniopharyngiomas that have progressed after prior radiation treatment with or without
surgical resection as measured by best response at any time during the first four cycles of
BRAF and MEK inhibitor treatment.
SECONDARY OBJECTIVES:
I. To determine the progression-free survival of patients with papillary craniopharyngiomas
receiving BRAF and MEK inhibitors.
II. To determine the toxicity of BRAF/MEK inhibitors in patients with papillary
craniopharyngiomas.
III. To determine the activity of BRAF and MEK inhibitor combination in papillary
craniopharyngiomas as measured by response of enhancing volume of craniopharyngioma.
IV. To determine the activity of BRAF and MEK inhibitor combination in papillary
craniopharyngiomas as measured by response of nonenhancing volume of craniopharyngioma.
V. To determine the overall survival of patients with papillary craniopharyngiomas receiving
BRAF and MEK inhibitors.
VI. To determine the duration of response in patients with papillary craniopharyngiomas
receiving BRAF and MEK inhibitors.
TERTIARY OBJECTIVES:
I. To evaluate visual fields in patients with papillary craniopharyngiomas who have received
BRAF/MEK inhibitors.
II. To evaluate pituitary hormone replacement over time in patients with papillary
craniopharyngiomas who have received BRAF/MEK inhibitors.
III. To evaluate the time to response in patients with papillary craniopharyngiomas receiving
BRAF and MEK inhibitors.
IV. To assess toxicity that may be associated with radiotherapy in patients with papillary
craniopharyngiomas who have received BRAF/MEK inhibitors.
V. To evaluate molecular biomarkers of response in papillary craniopharyngiomas.
VI. To evaluate circulating tumor cells and cell-free circulating deoxyribonucleic acid (DNA)
in patients with papillary craniopharyngiomas.
OUTLINE:
Patients receive vemurafenib orally (PO) twice daily (BID) on day 1-28 and cobimetinib PO
once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 5 courses in the
absence of disease progression or unacceptable toxicity. Patients may then receive radiation
therapy, surgery, or continued treatment with vemurafenib and cobimetinib at the discretion
of the treating physician.
After completion of study treatment, patients with disease progression are followed up every
16 weeks for 2 years and all other patients are followed up every 6 months for 5 years.
I. To determine the activity of BRAF and MEK inhibitor combination in untreated papillary
craniopharyngiomas as measured by best response at any time during the first four cycles of
BRAF and MEK inhibitor treatment.
II. To determine the activity of BRAF and MEK inhibitor combination in papillary
craniopharyngiomas that have progressed after prior radiation treatment with or without
surgical resection as measured by best response at any time during the first four cycles of
BRAF and MEK inhibitor treatment.
SECONDARY OBJECTIVES:
I. To determine the progression-free survival of patients with papillary craniopharyngiomas
receiving BRAF and MEK inhibitors.
II. To determine the toxicity of BRAF/MEK inhibitors in patients with papillary
craniopharyngiomas.
III. To determine the activity of BRAF and MEK inhibitor combination in papillary
craniopharyngiomas as measured by response of enhancing volume of craniopharyngioma.
IV. To determine the activity of BRAF and MEK inhibitor combination in papillary
craniopharyngiomas as measured by response of nonenhancing volume of craniopharyngioma.
V. To determine the overall survival of patients with papillary craniopharyngiomas receiving
BRAF and MEK inhibitors.
VI. To determine the duration of response in patients with papillary craniopharyngiomas
receiving BRAF and MEK inhibitors.
TERTIARY OBJECTIVES:
I. To evaluate visual fields in patients with papillary craniopharyngiomas who have received
BRAF/MEK inhibitors.
II. To evaluate pituitary hormone replacement over time in patients with papillary
craniopharyngiomas who have received BRAF/MEK inhibitors.
III. To evaluate the time to response in patients with papillary craniopharyngiomas receiving
BRAF and MEK inhibitors.
IV. To assess toxicity that may be associated with radiotherapy in patients with papillary
craniopharyngiomas who have received BRAF/MEK inhibitors.
V. To evaluate molecular biomarkers of response in papillary craniopharyngiomas.
VI. To evaluate circulating tumor cells and cell-free circulating deoxyribonucleic acid (DNA)
in patients with papillary craniopharyngiomas.
OUTLINE:
Patients receive vemurafenib orally (PO) twice daily (BID) on day 1-28 and cobimetinib PO
once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 5 courses in the
absence of disease progression or unacceptable toxicity. Patients may then receive radiation
therapy, surgery, or continued treatment with vemurafenib and cobimetinib at the discretion
of the treating physician.
After completion of study treatment, patients with disease progression are followed up every
16 weeks for 2 years and all other patients are followed up every 6 months for 5 years.
- Pre-registration: Patients must have local diagnosis of papillary craniopharyngioma
and have tissue slides available for submission to central pathology review; central
pathology review will include immunohistochemistry (IHC) testing for BRAF V600E
mutation (VE1 clone) and beta-catenin IHC (membranous, non-nuclear pattern) if needed
to confirm diagnosis of papillary craniopharyngioma
- Histologically proven papillary craniopharyngioma as documented by central pathology
review with positive BRAF V600E mutation by IHC
- Measurable disease and/or non-measurable disease
- Measurable disease, defined as bidimensionally measurable lesions with clearly
defined margins by magnetic resonance imaging (MRI) scans, with a minimum
diameter of 10 mm in both dimensions
- Progressive disease required in cohort B, defined as an increase in the
bidirectional area by 25% within the past 13 months after surgery or radiation;
progressive or recurrent disease is not required in cohort A, but is allowed
provided it is a new diagnosis and patient has not received prior treatment.
- Prior treatment
- Cohort A: No prior therapy received other than surgery
- Cohort B: Prior radiation therapy required (any type of prior radiation is
allowed)
- For patients treated with external beam radiation therapy, interstitial
brachytherapy or radiosurgery, an interval of >= 3 months must have elapsed
from completion of radiation therapy to registration
- Recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1
or less toxicity attributed to radiation with exception of alopecia, fatigue
- For patients enrolling on Cohort A or Cohort B:
- For patients treated with surgery, an interval of >= 21 days must have
elapsed prior to registration
- No prior treatment with BRAF or MEK inhibitors
- Steroid dosing stable for at least 4 days prior to registration
- Not pregnant and not nursing; for women of childbearing potential only, a negative
pregnancy test done =< 7 days prior to registration is required
- ECOG performance status =< 2
- Comorbid conditions
- No evidence of active bleeding, bleeding diathesis, or hemoptysis (>= 1/2
teaspoon of red blood) =< 8 weeks prior to registration
- No evidence of intracranial hemorrhage =< 4 weeks prior to registration
- Patients who have experienced thromboembolic event within 6 months prior to
registration must be on stable therapeutic anticoagulation for at least 4 weeks
prior to registration
- No symptomatic congestive heart failure (New York Heart Association class II,
III, or IV) within 6 months prior to registration
- No current unstable angina or uncontrolled arrhythmia
- No uncontrolled hypertension at time of registration (blood pressure [BP] >
150/95 despite antihypertensive therapy)
- No known history of prolonged QT syndrome
- No known history of ventricular arrhythmia within 6 months of registration
- No known history of uveitis or iritis =< 4 weeks prior to registration
- No known history of or evidence of retinal pathology that is considered a risk
factor for neurosensory retinal detachment, retinal vein occlusion (RVO), or
neovascular macular degeneration within 12 months of registration
- No known history of chronic lung disease
- Concomitant medications
- Chronic concomitant treatment with strong CYP3A4 inducers or CYP3A4 inhibitors is
not allowed; patients must discontinue the drug at least 14 days prior to study
registration
- Chronic concomitant treatment with CYP1A2 substrate is not allowed; patients must
discontinue the drug at least 14 days prior to study registration
- Absolute neutrophil count >= 1500/mm^3
- Platelets >= 100,000/mm^3
- Creatinine =< 1.5 mg/dL OR creatinine clearance >= 45mL/min
- Bilirubin =< 1.5 upper limit of normal (ULN)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 ULN
We found this trial at
84
sites
5900 Byron Center Ave SW
Wyoming, Michigan 49519
Wyoming, Michigan 49519
(616) 252-7200
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
Metro Health Hospital Metro Health is an integrated healthcare system offering expert, award-winning care that
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524 South Park Street
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
(269) 341-7654
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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200 North Park Street
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
(269) 382-2500
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Phone: 616-391-1230
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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1100 Fairview Avenue North
Seattle, Washington 98109
Seattle, Washington 98109
(206) 667-5000
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Phone: 800-804-8824
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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825 Eastlake Ave E
Seattle, Washington 98109
Seattle, Washington 98109
(206) 288-7222
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Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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1500 East Medical Center Drive
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Ann Arbor, Michigan 48109
800-865-1125
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Auburn, California 95603
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Phone: 415-209-2686
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Baltimore, Maryland 21287
Baltimore, Maryland 21287
410-955-5000
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Phone: 410-955-8804
Johns Hopkins University-Sidney Kimmel Cancer Center The name Johns Hopkins has become synonymous with excellence...
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265 Fremont St
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Battle Creek, Michigan 49017
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Phone: 616-391-1230
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Berkeley, California 94704
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Phone: 415-209-2686
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Billings, Montana 59101
Principal Investigator: Benjamin T. Marchello
Phone: 800-996-2663
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Birmingham, Alabama 35233
Principal Investigator: Louis B. Nabors
Phone: 205-934-0220
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Boise, Idaho 83706
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Phone: 734-712-3671
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Bolivar, Missouri 65613
Principal Investigator: Rakesh Gaur
Phone: 800-328-6010
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55 Fruit St
Boston, Massachusetts 02114
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(617) 724-4000
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617-632-3000
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915 Highland Blvd
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Burlingame, California 94010
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Phone: 650-696-4487
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Burnsville, Minnesota 55337
Burnsville, Minnesota 55337
(952) 892-2000
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Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
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3123 Medical Dr
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Caldwell, Idaho 83605
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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Principal Investigator: Stacy D. D'Andre
Phone: 415-209-2686
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Phone: 877-668-0683
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Chicago, Illinois 60612
Chicago, Illinois 60612
(312) 942-5000
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
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Mercy Hospital Mercy Hospital, located in Coon Rapids, Minnesota, is a 271-bed non-profit hospital that...
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6401 France Ave S
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(952) 924-5000
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Phone: 952-993-1517
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165 North University Avenue
Farmington, Utah 84025
Farmington, Utah 84025
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Phone: 888-424-2100
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550 Osborne Rd NE
Fridley, Minnesota 55432
Fridley, Minnesota 55432
(763) 236-5000
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Phone: 952-993-1517
Unity Hospital Unity Hospital is one of the Twin Cities
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410 East Spruce Street
Garden City, Kansas 67846
Garden City, Kansas 67846
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Phone: 913-948-5588
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Grand Rapids, Michigan 49503
Principal Investigator: Kathleen J. Yost
Phone: 773-702-9171
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100 Michigan St NE
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
(616) 391-1774
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Phone: 616-391-1230
Spectrum Health at Butterworth Campus Butterworth Hospital is one of four facilities that make up...
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Great Bend, Kansas 67530
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Phone: 913-948-5588
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1117 29th St S
Great Falls, Montana 59405
Great Falls, Montana 59405
(406) 771-7300
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Phone: 406-969-6060
Benefis Healthcare- Sletten Cancer Institute Benefis Hospitals has 516 beds at its two campuses (that...
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Houston, Texas 77030
Principal Investigator: Carlos Kamiya Matsuoka
Phone: 877-312-3961
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1521 Gull Rd
Kalamazoo, Michigan 49048
Kalamazoo, Michigan 49048
269) 226-7000
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
Borgess Medical Center At Borgess, healing is our calling. This is the place where people...
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310 Sunnyview Ln
Kalispell, Montana 59901
Kalispell, Montana 59901
(406) 752-5111
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
Kalispell Regional Medical Center Nestled in the beautiful Flathead Valley of Northwestern Montana, Kalispell Regional...
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2316 E Meyer Blvd
Kansas City, Missouri 64132
Kansas City, Missouri 64132
(816) 276-4000
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Phone: 913-948-5588
Research Medical Center Research Medical Center offers hospital and health clinic services across three Kansas...
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1 Medical Center Dr
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
(603) 650-5000
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Phone: 800-639-6918
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Maple Grove, Minnesota 55369
Principal Investigator: Daniel M. Anderson
Phone: 952-993-1517
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Principal Investigator: Daniel M. Anderson
Phone: 952-993-1517
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1575 Beam Ave
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
(651) 232-7000
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Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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Principal Investigator: Macarena I. De La Fuente
Phone: 305-243-2647
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Principal Investigator: George C. Bobustuc
Phone: 773-702-9171
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Principal Investigator: Daniel M. Anderson
Phone: 952-993-1517
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Principal Investigator: Daniel M. Anderson
Phone: 952-993-1517
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800 E 28th St
Minneapolis, Minnesota 55407
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(612) 863-4000
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Phone: 952-993-1517
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Missoula, Montana 59801
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
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1700 Coffee Rd
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(209) 526-4500
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Phone: 952-993-1517
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Principal Investigator: Stacy D. D'Andre
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Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
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501 Hospital Rd
New Richmond, Wisconsin 54017
New Richmond, Wisconsin 54017
(715) 243-2800
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Phone: 952-993-1517
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445 E 69th St
New York, New York 10021
New York, New York 10021
(212) 746-1067
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Phone: 212-746-1848
Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
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Niles, Michigan 49120
Principal Investigator: Kathleen J. Yost
Phone: 269-556-2880
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Principal Investigator: Daniela A. Bota
Phone: 877-827-8839
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Principal Investigator: Stacy D. D'Andre
Phone: 415-209-2686
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Post Falls, Idaho 83854
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
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300 N Patterson Rd
Reed City, Michigan 49677
Reed City, Michigan 49677
(231) 832-3271
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
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3300 Oakdale Ave. N.
Robbinsdale, Minnesota 55422
Robbinsdale, Minnesota 55422
763-520-5200
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Phone: 952-993-1517
North Memorial Medical Health Center North Memorial Health Care is a comprehensive health care system...
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Rochester, Minnesota 55905
Principal Investigator: Evanthia Galanis
Phone: 855-776-0015
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Principal Investigator: Stacy D. D'Andre
Phone: 415-209-2686
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Roseville, California 95661
Principal Investigator: Stacy D. D'Andre
Phone: 415-209-2686
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Sacramento, California 95819
Principal Investigator: Stacy D. D'Andre
Phone: 916-454-6500
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1234 West Napier Avenue
Saint Joseph, Michigan 49085
Saint Joseph, Michigan 49085
Principal Investigator: Kathleen J. Yost
Phone: 800-865-7884
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3900 Hollywood Road
Saint Joseph, Michigan 49085
Saint Joseph, Michigan 49085
(269) 428-4411
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
Marie Yeager Cancer Center The Marie Yeager Cancer Center is located at the Lakeland Health...
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660 S Euclid Ave
Saint Louis, Missouri 63110
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(314) 362-5000
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Phone: 800-600-3606
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3850 Park Nicollet Blvd
Saint Louis Park, Minnesota 55416
Saint Louis Park, Minnesota 55416
(952) 993-3123
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Phone: 952-993-1517
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640 Jackson Street
Saint Paul, Minnesota 55101
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651-254-3456
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Phone: 952-993-1517
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333 Smith Ave
Saint Paul, Minnesota 55102
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(651) 241-8000
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Phone: 952-993-1517
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
(801) 585-0303
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Phone: 888-424-2100
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San Francisco, California 94114
Principal Investigator: Stacy D. D'Andre
Phone: 415-209-2686
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1959 NE Pacific St
Seattle, Washington 98195
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(206) 598-3300
Principal Investigator: Lynne P. Taylor
Phone: 800-804-8824
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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1455 St Francis Ave
Shakopee, Minnesota 55379
Shakopee, Minnesota 55379
(952) 428-3000
Principal Investigator: Daniel M. Anderson
Phone: 952-993-1517
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South Jordan, Utah 84095
Principal Investigator: Adam L. Cohen
Phone: 888-424-2100
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630 Medical Dr
Stillwater, Minnesota 84010
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(801) 299-2200
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Phone: 952-993-1517
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Sunnyvale, California 94806
Principal Investigator: Stacy D. D'Andre
Phone: 415-209-2686
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105 Sixth St
Traverse City, Michigan 49684
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(231) 935-5000
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Phone: 616-391-1230
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Principal Investigator: Stacy D. D'Andre
Phone: 415-209-2686
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Vallejo, California 94589
Principal Investigator: Stacy D. D'Andre
Phone: 415-209-2686
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500 S Maple Street
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Phone: 952-993-1517
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301 Becker Ave SW
Willmar, Minnesota 56201
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(320) 235-4543
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Phone: 952-993-1517
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1 Medical Center Blvd
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