Ulixertinib in Treating Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial)



Status:Recruiting
Conditions:Cancer, Brain Cancer, Brain Cancer, Brain Cancer, Brain Cancer, Infectious Disease, Lymphoma, Lymphoma, Hematology
Therapuetic Areas:Hematology, Immunology / Infectious Diseases, Oncology
Healthy:No
Age Range:Any - 21
Updated:4/6/2019
Start Date:October 1, 2018
End Date:December 31, 2025

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NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of BVD-523FB (Ulixertinib) in Patients With Tumors Harboring Activating MAPK Pathway Mutations

This phase II Pediatric MATCH trial studies how well ulixertinib works in treating patients
with solid tumors that have spread to other places in the body (advanced), non-Hodgkin
lymphoma, or histiocytic disorders that have a genetic alteration (mutation) in a signaling
pathway called MAPK. A signaling pathway consists of a group of molecules in a cell that
control one or more cell functions. Genes in the MAPK pathway are frequently mutated in many
types of cancers. Ulixertinib may stop the growth of cancer cells that have mutations in the
MAPK pathway.

PRIMARY OBJECTIVES:

I. To determine the objective response rate (ORR; complete response + partial response) in
pediatric patients treated with BVD-523FB (ulixertinib) with advanced solid tumors (including
central nervous system [CNS] tumors), non-Hodgkin lymphomas or histiocytic disorders that
harbor activating genetic alterations in the MAPK pathway.

SECONDARY OBJECTIVES:

I. To estimate the progression free survival in pediatric patients treated with BVD-523FB
(ulixertinib) with advanced solid tumors (including CNS tumors), non-Hodgkin lymphomas or
histiocytic disorders that harbor activating genetic alterations in the MAPK pathway.

II. To obtain information about the tolerability of BVD-523FB (ulixertinib) in children and
adolescents with relapsed or refractory cancer.

III. To provide preliminary estimates of the pharmacokinetics of BVD-523FB (ulixertinib) in
children and adolescents with relapsed or refractory cancer.

EXPLORATORY OBJECTIVES:

I. To evaluate other biomarkers as predictors of response to BVD-523FB (ulixertinib) and
specifically, whether tumors that harbor different mutations or fusions will demonstrate
differential response to BVD-523FB (ulixertinib) treatment.

II. To explore approaches to profiling changes in tumor genomics over time through evaluation
of circulating tumor deoxyribonucleic acid (DNA).

OUTLINE: This is a dose-escalation study.

Patients receive ulixertinib orally (PO) twice daily (BID). Courses repeat every 28 days for
up to 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Inclusion Criteria:

- Patient must have enrolled onto APEC1621SC and must have been given a treatment
assignment to MATCH to APEC1621J based on the presence of an actionable mutation.

- Patients must have a body surface area >= 0.54 m^2 at the time of study enrollment.

- Patients must have radiographically measurable disease at the time of study
enrollment. Patients with neuroblastoma who do not have measurable disease but have
metaiodobenzylguanidine (MIBG)+ evaluable disease are eligible. Measurable disease in
patients with central nervous system (CNS) involvement is defined as tumor that is
measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and
visible on more than one slice.

- Note: The following do not qualify as measurable disease:

- Malignant fluid collections (e.g., ascites, pleural effusions)

- Bone marrow infiltration except that detected by MIBG scan for neuroblastoma

- Lesions only detected by nuclear medicine studies (e.g., bone, gallium or
positron emission tomography [PET] scans) except as noted for neuroblastoma

- Elevated tumor markers in plasma or cerebrospinal fluid (CSF)

- Previously radiated lesions that have not demonstrated clear progression
post radiation

- Leptomeningeal lesions that do not meet the measurement requirements for
Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

- Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16
years of age. Note: Neurologic deficits in patients with CNS tumors must have been
relatively stable for at least 7 days prior to study enrollment. Patients who are
unable to walk because of paralysis, but who are up in a wheelchair, will be
considered ambulatory for the purpose of assessing the performance score.

- Patients must have fully recovered from the acute toxic effects of all prior
anti-cancer therapy and must meet the following minimum duration from prior
anti-cancer directed therapy prior to enrollment. If after the required timeframe, the
numerical eligibility criteria are met, e.g. blood count criteria, the patient is
considered to have recovered adequately.

- Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive.

- >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy
(42 days if prior nitrosourea).

- Anti-cancer agents not known to be myelosuppressive (e.g. not associated with
reduced platelet or ANC counts): >= 7 days after the last dose of agent.

- Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody,
and toxicity related to prior antibody therapy must be recovered to Grade =< 1.

- Corticosteroids: If used to modify immune adverse events related to prior
therapy, ≥ 14 days must have elapsed since last dose of corticosteroid.

- Hematopoietic growth factors: >= 14 days after the last dose of a long-acting
growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor. For
growth factors that have known adverse events occurring beyond 7 days after
administration, this period must be extended beyond the time during which adverse
events are known to occur. The duration of this interval must be discussed with
the study chair and the study-assigned Research Coordinator.

- Interleukins, Interferons and Cytokines (other than hematopoietic growth
factors): >= 21 days after the completion of interleukins, interferon or
cytokines (other than hematopoietic growth factors).

- Stem cell Infusions (with or without TBI):

- Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem
cell infusion including DLI or boost infusion: >= 84 days after infusion and
no evidence of GVHD.

- Autologous stem cell infusion including boost infusion: >= 42 days.

- Cellular Therapy: >= 42 days after the completion of any type of cellular therapy
(e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.).

- Radiotherapy (XRT)/External Beam Irradiation including Protons: >= 14 days after
local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of
the pelvis; >= 42 days if other substantial brain metastases (BM) radiation.

- Note: Radiation may not be delivered to "measurable disease" tumor site(s)
being used to follow response to subprotocol treatment.

- Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days
after systemically administered radiopharmaceutical therapy.

- Patients must not have received prior exposure to BVD-523FB (ulixertinib) or
other ERK inhibitors.

- For patients with solid tumors without known bone marrow involvement: Peripheral
absolute neutrophil count (ANC) >= 1000/mm^3 (within 7 days prior to enrollment).

- For patients with solid tumors without known bone marrow involvement: Platelet count
>= 100,000/mm^3 (transfusion independent, defined as not receiving platelet
transfusions for at least 7 days prior to enrollment).

- Patients with known bone marrow metastatic disease will be eligible for study (may
receive transfusions provided they are not known to be refractory to red cell or
platelet transfusions). These patients will not be evaluable for hematologic toxicity.

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70ml/min/1.73
m^2, or (within 7 days prior to enrollment).

- A serum creatinine based on age/gender (within 7 days prior to enrollment).

- Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for
age (within 7 days prior to enrollment).

- Serum glutamate-pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135
U/L. (For the purpose of this study, the ULN for SGPT is 45 U/L.) (within 7 days prior
to enrollment).

- Serum albumin >= 2 g/dL (within 7 days prior to enrollment).

- Shortening fraction of >= 27% by echocardiogram, or (within 7 days prior to
enrollment).

- Ejection fraction of >= 50% by gated radionuclide study (within 7 days prior to
enrollment).

- QTc interval =< 480 milliseconds (within 7 days prior to enrollment).

- Patients must be able to swallow intact capsules.

- All patients and/or their parents or legally authorized representatives must sign a
written informed consent. Assent, when appropriate, will be obtained according to
institutional guidelines.

Exclusion Criteria:

- Pregnant or breast-feeding women will not be entered on this study due to risks of
fetal and teratogenic adverse events as seen in animal/human studies. Pregnancy tests
must be obtained in girls who are post-menarchal. Males or females of reproductive
potential may not participate unless they have agreed to use an effective
contraceptive method for the duration of study treatment and for 3 months after last
dose of BVD-523FB (ulixertinib).

- Patients receiving corticosteroids who have not been on a stable or decreasing dose of
corticosteroid for at least 7 days prior to enrollment are not eligible. If used to
modify immune adverse events related to prior therapy, >= 14 days must have elapsed
since last dose of corticosteroid.

- Patients who are currently receiving another investigational drug are not eligible.

- Patients who are currently receiving other anti-cancer agents are not eligible.

- Patients who are receiving cyclosporine, tacrolimus or other agents to prevent
graft-versus-host disease post bone marrow transplant are not eligible for this trial.

- Patients who are currently receiving drugs that are strong inducers or inhibitors of
CYP3A4 are not eligible. Strong inducers or inhibitors of CYP3A4 should be avoided
from 14 days prior to enrollment to the end of the study. Note: CYP3A4 inducing
anti-epileptic drugs and dexamethasone for CNS tumors or metastases, on a stable dose,
are allowed.

- Patients who are currently receiving drugs that are strong inducers or inhibitors of
CYP1A2 and CYP2D6 are not eligible. Strong inhibitors of CYP1A2 (eg., ciprofloxacin,
enoxacin, fluvoxamine, zafirlukast) should be avoided from 14 days prior to enrollment
to the end of the study. Strong inhibitors of CYP2D6 (e.g., bupropion, paroxetine,
fluoxetine, quinidine, terbinafine) should also be avoided from 14 days prior to
enrollment to the end of the study.

- Patients with known significant ophthalmologic conditions (uncontrolled glaucoma,
history of retinal vein occlusion or retinal detachment, excluding patients with
longstanding findings secondary to existing conditions) are not eligible.

- Patients who have an uncontrolled infection are not eligible.

- Patients who have received a prior solid organ transplantation are not eligible.

- Patients who in the opinion of the investigator may not be able to comply with the
safety monitoring requirements of the study are not eligible.
We found this trial at
73
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Principal Investigator: Jeffrey S. Dome
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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4900 Mueller Boulevard
Austin, Texas 78723
(512) 324-0000
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Dell Children's Medical Center of Central Texas Welcome to Dell Children
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1600 7th Avenue
Birmingham, Alabama 35233
(205) 638-9100
Principal Investigator: Elizabeth D. Alva
Children's Hospital of Alabama Children
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Clare J. Twist
Phone: 800-767-9355
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1 South Prospect Street
Burlington, Vermont 05401
802-656-8990
Principal Investigator: Jessica L. Heath
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Erin H. Breese
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7777 Forest Ln # C840
Dallas, Texas 75230
(972) 566-7000
Principal Investigator: Stanton C. Goldman
Phone: 972-566-5588
Medical City Dallas Hospital If you have concerns for your health, that of a family...
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1200 Pleasant Street
Des Moines, Iowa 50309
(515) 241-KIDS
Principal Investigator: Samantha L. Mallory
Blank Children's Hospital Blank Children's Hospital is completely dedicated to meeting the unique health care...
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2500 N State St
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(601) 984-1000
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4650 Sunset Blvd
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262 Danny Thomas Pl
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601 Children's Lane
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747 52nd St
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530 Northeast Glen Oak Avenue
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(309) 624-4945
Principal Investigator: Jaime M. Libes
Phone: 888-226-4343
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South 34th Street
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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Phone: 503-494-1080
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401 College Street
Richmond, Virginia 23298
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60 Crittenden Blvd # 70
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4502 Medical Drive
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1540 East Hospital Drive
Ann Arbor, Michigan 48109
(877) 475-6688
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Asheville, North Carolina 28801
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Margaret E. Macy
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401 North Broadway
Baltimore, Maryland 21287
410-955-5000
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489 State St
Bangor, Maine 04401
(207) 973-7000
Principal Investigator: Nadine P. SantaCruz
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Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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55 Fruit St
Boston, Massachusetts 02114
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450 Brookline Ave
Boston, Massachusetts 2215
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Charlotte, North Carolina 28204
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Dallas, Texas 75390
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
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Dayton, Ohio 45404
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9333 Imperial Highway
Downey, California 90242
Principal Investigator: Robert M. Cooper
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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801 7th Avenue
Fort Worth, Texas 76104
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
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Houston, Texas 77030
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
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Iowa City, Iowa 52242
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Kansas City, Missouri 64108
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2018 W Clinch Ave
Knoxville, Tennessee 37916
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1 Children's Way
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11234 Anderson St
Loma Linda, California 92354
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Long Beach, California 90806
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Madera, California 93638
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
Principal Investigator: Kenneth B. De Santes
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University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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Mesa, Arizona 85202
Principal Investigator: Hardeo K. Panchoosingh
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Miami, Florida 33136
Principal Investigator: Julio C. Barredo
Phone: 305-243-2647
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Miami, Florida 33155
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Minneapolis, Minnesota 55455
Principal Investigator: Emily G. Greengard
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2525 Chicago Ave
Minneapolis, Minnesota 55404
(612) 813-6000
Principal Investigator: Michael K. Richards
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Nashville, Tennessee 37232
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New Hyde Park, New York 11040
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New Orleans, Louisiana 70121
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New Orleans, Louisiana 70118
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New York, New York 10032
Principal Investigator: Alice Lee
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New York, New York 10016
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Oakland, California 94611
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: Rene Y. McNall-Knapp
Phone: 405-271-8777
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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8200 Dodge St
Omaha, Nebraska 68114
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Minnie Abromowitch
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Orlando, Florida 32806
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2801 N Gantenbein Ave
Portland, Oregon 97227
(503) 276-6500
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Rochester, Minnesota 55905
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
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San Antonio, Texas 78207
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San Francisco, California 94158
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San Juan, 00912
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Douglas S. Hawkins
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101 W 8th Ave
Spokane, Washington 99204
(509) 474-3131
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Syracuse, New York 13214
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9040 Jackson Ave
Tacoma, Washington 98431
(253) 968-1110
Principal Investigator: Melissa A. Forouhar
Phone: 253-968-0129
Madigan Army Medical Center Located on Joint Base Lewis-McChord, Madigan Army Medical Center comprises a...
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Tacoma, WA
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Tampa, Florida 33607
Principal Investigator: Dana A. Obzut
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Tampa, FL
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2142 N Cove Blvd
Toledo, Ohio 43606
(419) 291-5437
Principal Investigator: Jamie L. Dargart
Phone: 419-824-1842
The Toledo Hospital/Toledo Children's Hospital ProMedica's Mission is to improve your health and well-being. And...
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Toledo, OH
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