Melanoma (Skin Cancer)
EA6191 / BAMM2
Testing the Combination of Dabrafenib and Trametinib with or without Hydroxychloroquine in Patients with Stage IIIC or IV BRAF V600E/K Melanoma with Elevated LDH
STATUS: Closed to Accrual
This phase II trial investigates how well adding hydroxychloroquine to the standard treatment of dabrafenib and trametinib works to overcome resistance and delay disease progression in treating patients with stage IIIC or IV BRAF V600E/K melanoma with elevated lactate dehydrogenase (LDH). Hydroxychloroquine may cause cell death in tumor cells that rely on a process called "autophagy" for survival. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving hydroxychloroquine together with dabrafenib and trametinib may work better than dabrafenib and trametinib alone to shrink and stabilize the cancer.
- Patient must be >= 18 years of age
- Patient must have locally advanced unresectable stage IIIC or stage IV melanoma
- Patient must have BRAF V600E or BRAF V600K tumor genotype based on a Clinical Laboratory Improvement Act (CLIA) approved assay
- Patient must have serum LDH > upper limit of normal per institution standards
- Patient must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Baseline measurements of sites of disease must be obtained within 3 weeks prior to study randomization
- Patient must have been treated with prior immune checkpoint inhibitor therapy (anti PD-1 antibody, anti-CTLA-4 antibody or a combination regimen including either or both agents) either in the adjuvant or metastatic setting. Patient may have received investigational agents in combination with standard therapy, as long as it was adhering to the timeframes * Patient must have discontinued active immunotherapy (IL-2, interferon, anti-CTLA-4 antibody, anti-PD-1 antibody etc.) or chemotherapy at least 4 weeks prior to randomization * Patient must have discontinued any oral targeted therapy at least 2 weeks prior to randomization * Patients must not receive any other investigational anticancer therapy during the period on study or the 4 weeks prior to randomization
- Patient may have been treated with prior adjuvant therapy including combined BRAF and MEK inhibitor therapy. Patients will be eligible if they tolerated this therapy and did not discontinue the therapy due to toxicity AND >= 6 months have elapsed since the end of adjuvant BRAF and MEK inhibition. If patients received BRAF and MEK inhibitor therapy in the metastatic setting, they are not eligible
- Patient may have been treated with prior chemotherapy or radiation therapy
- Patients who are known to be experiencing an objective partial response to immunotherapy at the time of study enrollment are not eligible
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All females of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- Women of childbearing potential and sexually active males must not expect to conceive or father children by using accepted and effective method(s) of contraception or abstaining from sexual intercourse for the duration of their participation in the study and for 4 months after the last dose of protocol treatment
- Patient must have recovered from clinically significant reversible toxicities from previous treatment prior to randomization. Abnormal laboratory values may be grade 1, as long as they meet the eligibility criteria
- Patient must not have a history of interstitial lung disease (ILD) or chronic pneumonitis * NOTE: If there is radiographic evidence of ILD that is clinically insignificant and asymptomatic, the patient would be eligible
- Patient must not have porphyria or psoriasis due to risk of disease exacerbation unless the disease is well controlled and they are under the care of a specialist for the disorder who agrees to monitor the patient for exacerbations
- Patient must not have a previously documented retinal vein occlusion
- Patient must not have a history or evidence of increased cardiovascular risk including: * Left ventricular ejection fraction (LVEF) < institutional lower limit of normal measured within 14 days prior to randomization * A QT interval corrected for heart rate using the Bazett‘s formula >= 480 msec * Current clinically significant uncontrolled arrhythmias. Exception: Patients with controlled atrial fibrillation for > 30 days prior to randomization are eligible * Acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization * Abnormal cardiac valve morphology (>= grade 2) documented by echocardiogram unless a cardiologist concludes the valve abnormality is not clinically significant. Patients with grade 1 abnormalities (i.e., mild regurgitation/stenosis) are eligible * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
- Patient must be able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
- Patient with known serious concurrent infection or medical illness, including psychiatric disorders, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety are not eligible
- Patient must not be receiving concurrent therapy for their tumor (i.e. chemotherapeutics or investigational agents). Radiotherapy delivered to palliate pain is allowed as long as it is not targeting a lesion that meets RECIST criteria for progression. Radiation therapy to the surgical bed with gamma knife radiotherapy while on treatment during the first cycle is allowed for small volume surgically resected brain metastases. Gamma knife radiotherapy for known active, asymptomatic small volume central nervous system (CNS) lesions may be performed during the first cycle while on study. Radiotherapy for new CNS lesions identified beyond the first cycle is not allowed on study
- Patient must not have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study drug, or excipients or to dimethyl sulfoxide (DMSO)
- Patient must not have received cytochrome P450 enzyme –inducing anticonvulsant drugs (extended-interval aminoglycoside dosing [EIADs]) (i.e. phenytoin, carbamazepine, phenobarbital, primidone or oxcarbazepine) within 4 weeks prior to randomization
- Patient must not have a current use of a prohibited medication
- Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
- Absolute neutrophil count >= 1,500/mcL (obtained =< 14 days prior to protocol randomization)
- Platelets >= 100,000/mcL (obtained =< 14 days prior to protocol randomization)
- Total bilirubin =< institutional upper limit of normal (ULN) (obtained =< 14 days prior to protocol randomization)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x institutional ULN (obtained =< 14 days prior to protocol randomization)
- Creatinine =< 1.5 x institutional ULN (obtained =< 14 days prior to protocol randomization)
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Patient with asymptomatic new or progressive brain metastases (active brain metastases) are eligible if the treating physician determines that CNS specific treatment is not required * NOTE: Patient with treated brain metastases are eligible. No brain imaging is required, however, 1 week must elapse after gamma knife therapy. Patient treated with whole brain radiation that have been stable for 2 months are eligible. Patient are excluded if they have leptomeningeal disease or metastases causing spinal cord compression that are symptomatic or untreated or not stable (documented by imaging) for at least 3 months or requiring corticosteroids. Patients on a stable dose of corticosteroids for at least 1 month or who have been off of corticosteroids for at least 1 week are eligible
United States
AK
Anchorage
Alaska Breast Care and Surgery LLC
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org
Alaska Oncology and Hematology LLC
Contact: Site Public Contact
Email: AKPAMC.OncologyResearchSupport@providence.org
Alaska Women's Cancer Care
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Email: AKPAMC.OncologyResearchSupport@providence.org
Anchorage Associates in Radiation Medicine
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Email: AKPAMC.OncologyResearchSupport@providence.org
Anchorage Oncology Centre
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Email: AKPAMC.OncologyResearchSupport@providence.org
Anchorage Radiation Therapy Center
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Email: AKPAMC.OncologyResearchSupport@providence.org
Katmai Oncology Group
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Email: AKPAMC.OncologyResearchSupport@providence.org
Providence Alaska Medical Center
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Email: AKPAMC.OncologyResearchSupport@providence.org
AR
Ft. Smith
Mercy Hospital Fort Smith
Contact: Site Public Contact
Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
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Email: ResearchInstituteInquiries@CommonSpirit.org
AZ
Phoenix
Cancer Center at Saint Joseph's
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Email: CancerInstitute@DignityHealth.org
Mayo Clinic Hospital in Arizona
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Scottsdale
Mayo Clinic in Arizona
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CA
Arroyo Grande
Mission Hope Medical Oncology - Arroyo Grande
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Email: ResearchInstituteInquiries@CommonSpirit.org
Burbank
Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Email: Najee.Boucher@providence.org
Carmichael
Mercy Cancer Center - Carmichael
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Email: ecog.rss@jimmy.harvard.edu
Mercy San Juan Medical Center
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Email: OncologyResearch@DignityHealth.org
Elk Grove
Mercy Cancer Center - Elk Grove
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Email: OncologyResearch@DignityHealth.org
Los Angeles
Cedars Sinai Medical Center
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The Angeles Clinic and Research Institute - West Los Angeles Office
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Email: ecog.rss@jimmy.harvard.edu
Rocklin
Mercy Cancer Center - Rocklin
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Email: OncologyResearch@DignityHealth.org
Sacramento
Mercy Cancer Center - Sacramento
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Email: OncologyResearch@DignityHealth.org
San Luis Obispo
Pacific Central Coast Health Center-San Luis Obispo
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Email: ResearchInstituteInquiries@CommonSpirit.org
Santa Maria
Mission Hope Medical Oncology - Santa Maria
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Woodland
Woodland Memorial Hospital
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Email: OncologyResearch@DignityHealth.org
CO
Colorado Springs
Penrose-Saint Francis Healthcare
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Email: ResearchTracking@Centura.Org
Rocky Mountain Cancer Centers-Penrose
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Email: ResearchTracking@Centura.Org
Saint Francis Cancer Center
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Email: ResearchTracking@Centura.Org
Denver
Porter Adventist Hospital
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Email: ResearchTracking@Centura.Org
Durango
Mercy Medical Center
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Email: ResearchTracking@Centura.Org
Southwest Oncology PC
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Email: ResearchTracking@Centura.Org
Lakewood
Saint Anthony Hospital
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Email: ResearchTracking@Centura.Org
Littleton
Littleton Adventist Hospital
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Email: ResearchTracking@Centura.Org
Longmont
Longmont United Hospital
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Email: ResearchTracking@Centura.Org
Rocky Mountain Cancer Centers-Longmont
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Email: ResearchTracking@Centura.Org
Parker
Parker Adventist Hospital
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Email: ResearchTracking@Centura.Org
Pueblo
Saint Mary Corwin Medical Center
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Email: ResearchTracking@Centura.Org
DC
Washington
MedStar Georgetown University Hospital
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DE
Lewes
Beebe Medical Center
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Email: research@beebehealthcare.org
Millville
Beebe South Coastal Health Campus
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Email: research@beebehealthcare.org
Newark
Christiana Care Health System-Christiana Hospital
Contact: Site Public Contact
Email: lbarone@christianacare.org
Delaware Clinical and Laboratory Physicians PA
Contact: Site Public Contact
Email: mhayden@christianacare.org
Helen F Graham Cancer Center
Contact: Site Public Contact
Email: lbarone@christianacare.org
Medical Oncology Hematology Consultants PA
Contact: Site Public Contact
Email: lbarone@christianacare.org
Rehoboth Beach
Beebe Health Campus
Contact: Site Public Contact
Email: research@beebehealthcare.org
Seaford
TidalHealth Nanticoke / Allen Cancer Center
Contact: Site Public Contact
Email: anna-maria.howard@peninsula.org
Wilmington
Christiana Care Health System-Wilmington Hospital
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Email: lbarone@christianacare.org
FL
Aventura
UM Sylvester Comprehensive Cancer Center at Aventura
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Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
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Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
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Miami
UM Sylvester Comprehensive Cancer Center at Kendall
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University of Miami Miller School of Medicine-Sylvester Cancer Center
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Plantation
UM Sylvester Comprehensive Cancer Center at Plantation
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IA
Ames
Mary Greeley Medical Center
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McFarland Clinic - Ames
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Email: ksoder@mcfarlandclinic.com
Boone
McFarland Clinic - Boone
Contact: Site Public Contact
Carroll
Saint Anthony Regional Hospital
Contact: Site Public Contact
Email: sbenson@iora.org
Clive
Mercy Cancer Center-West Lakes
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Email: cancerresearch@mercydesmoines.org
Mission Cancer and Blood - West Des Moines
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Council Bluffs
Alegent Health Mercy Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org
Creston
Greater Regional Medical Center
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Email: cancerresearch@mercydesmoines.org
Des Moines
Broadlawns Medical Center
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Iowa Lutheran Hospital
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Iowa Methodist Medical Center
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Mercy Medical Center - Des Moines
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Email: cancerresearch@mercydesmoines.org
Mission Cancer and Blood - Des Moines
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Mission Cancer and Blood - Laurel
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Fort Dodge
McFarland Clinic - Trinity Cancer Center
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Trinity Regional Medical Center
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Jefferson
McFarland Clinic - Jefferson
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Marshalltown
McFarland Clinic - Marshalltown
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West Des Moines
Mercy Medical Center-West Lakes
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Email: cancerresearch@mercydesmoines.org
Methodist West Hospital
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ID
Boise
Saint Luke's Cancer Institute - Boise
Contact: Site Public Contact
Email: eslinget@slhs.org
Fruitland
Saint Luke's Cancer Institute - Fruitland
Contact: Site Public Contact
Email: eslinget@slhs.org
Meridian
Saint Luke's Cancer Institute - Meridian
Contact: Site Public Contact
Email: eslinget@slhs.org
Nampa
Saint Luke's Cancer Institute - Nampa
Contact: Site Public Contact
Email: eslinget@slhs.org
Twin Falls
Saint Luke's Cancer Institute - Twin Falls
Contact: Site Public Contact
Email: eslinget@slhs.org
IL
Alton
Saint Anthony's Health
Contact: Site Public Contact
Aurora
Rush - Copley Medical Center
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com
Burr Ridge
Loyola Center for Health at Burr Ridge
Contact: Site Public Contact
Danville
Carle at The Riverfront
Contact: Site Public Contact
Email: Research@carle.com
Effingham
Carle Physician Group-Effingham
Contact: Site Public Contact
Email: Research@carle.com
Homer Glen
Loyola Medicine Homer Glen
Contact: Site Public Contact
Mattoon
Carle Physician Group-Mattoon/Charleston
Contact: Site Public Contact
Email: Research@carle.com
Maywood
Loyola University Medical Center
Contact: Site Public Contact
Melrose Park
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Contact: Site Public Contact
Mount Vernon
Good Samaritan Regional Health Center
Contact: Site Public Contact
Urbana
Carle Cancer Center
Contact: Site Public Contact
Email: Research@carle.com
The Carle Foundation Hospital
Contact: Site Public Contact
Email: Research@carle.com
Yorkville
Rush-Copley Healthcare Center
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com
IN
Richmond
Reid Health
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
KS
Garden City
Central Care Cancer Center - Garden City
Contact: Site Public Contact
Email: aroland@kccop.org
Great Bend
Central Care Cancer Center - Great Bend
Contact: Site Public Contact
Email: aroland@kccop.org
KY
Bardstown
Flaget Memorial Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Corbin
Commonwealth Cancer Center-Corbin
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Lexington
Saint Joseph Hospital
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
Saint Joseph Hospital East
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Email: ResearchInstituteInquiries@CommonSpirit.org
Saint Joseph Radiation Oncology Resource Center
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Email: ResearchInstituteInquiries@CommonSpirit.org
London
Saint Joseph London
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Louisville
Jewish Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org
Saints Mary and Elizabeth Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org
UofL Health Medical Center Northeast
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Email: ctoinfo@louisville.edu
Mount Sterling
Saint Joseph Mount Sterling
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Email: ecog.rss@jimmy.harvard.edu
Shepherdsville
Jewish Hospital Medical Center South
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Email: ResearchInstituteInquiries@CommonSpirit.org
MD
Baltimore
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Contact: Site Public Contact
MN
Rochester
Mayo Clinic in Rochester
Contact: Site Public Contact
MO
Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Contact: Site Public Contact
Bolivar
Central Care Cancer Center - Bolivar
Contact: Site Public Contact
Email: aroland@kccop.org
Branson
Cox Cancer Center Branson
Contact: Site Public Contact
Joplin
Freeman Health System
Contact: Site Public Contact
Email: LJCrockett@freemanhealth.com
Mercy Hospital Joplin
Contact: Site Public Contact
Email: esmeralda.carrillo@mercy.net
Rolla
Delbert Day Cancer Institute at PCRMC
Contact: Site Public Contact
Email: research@phelpshealth.org
Mercy Clinic-Rolla-Cancer and Hematology
Contact: Site Public Contact
Saint Joseph
Heartland Regional Medical Center
Contact: Site Public Contact
Email: linda.schumacher@mymlc.com
Saint Louis
Mercy Hospital Saint Louis
Contact: Site Public Contact
Mercy Hospital South
Contact: Site Public Contact
Email: janet.lesko@mercy.net
Saint Louis Cancer and Breast Institute-South City
Contact: Site Public Contact
Springfield
CoxHealth South Hospital
Contact: Site Public Contact
Mercy Hospital Springfield
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Washington
Mercy Hospital Washington
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MT
Missoula
Saint Patrick Hospital - Community Hospital
Contact: Site Public Contact
Email: amy.hanneman@providence.org
NE
Grand Island
Nebraska Cancer Specialists/Oncology Hematology West PC
Contact: Site Public Contact
Kearney
CHI Health Good Samaritan
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Lincoln
Saint Elizabeth Regional Medical Center
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Email: ResearchInstituteInquiries@CommonSpirit.org
Omaha
Alegent Health Bergan Mercy Medical Center
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Email: ResearchInstituteInquiries@CommonSpirit.org
Alegent Health Immanuel Medical Center
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Email: ResearchInstituteInquiries@CommonSpirit.org
Alegent Health Lakeside Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org
Creighton University Medical Center
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Email: ResearchInstituteInquiries@CommonSpirit.org
Papillion
Midlands Community Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
NY
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Contact: Site Public Contact
Email: CancerTrials@nyulangone.org
OH
Beavercreek
Indu and Raj Soin Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Boardman
Saint Elizabeth Boardman Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Centerville
Dayton Physicians LLC-Miami Valley South
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Miami Valley Hospital South
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Cincinnati
Bethesda North Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Good Samaritan Hospital - Cincinnati
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Oncology Hematology Care Inc-Kenwood
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
TriHealth Cancer Institute-Anderson
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
TriHealth Cancer Institute-Westside
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Dayton
Dayton Physician LLC - Englewood
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Miami Valley Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Miami Valley Hospital North
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Findlay
Armes Family Cancer Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Blanchard Valley Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Orion Cancer Care
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Franklin
Atrium Medical Center-Middletown Regional Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Dayton Physicians LLC-Atrium
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Greenville
Dayton Physicians LLC-Wayne
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Wayne Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Kettering
Greater Dayton Cancer Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Kettering Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Springfield
Springfield Regional Cancer Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Springfield Regional Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Troy
Dayton Physicians LLC - Troy
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Upper Valley Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Warren
Saint Joseph Warren Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Youngstown
Saint Elizabeth Youngstown Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
OK
Oklahoma City
Mercy Hospital Oklahoma City
Contact: Site Public Contact
OR
Bend
Saint Charles Health System
Contact: Site Public Contact
Email: nosall@stcharleshealthcare.org
Clackamas
Clackamas Radiation Oncology Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org
Providence Cancer Institute Clackamas Clinic
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org
Coos Bay
Bay Area Hospital
Contact: Site Public Contact
Email: cherie.cox@bayareahospital.org
Newberg
Providence Newberg Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org
Portland
Providence Portland Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org
Providence Saint Vincent Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org
Redmond
Saint Charles Health System-Redmond
Contact: Site Public Contact
PA
Chadds Ford
Christiana Care Health System-Concord Health Center
Contact: Site Public Contact
Email: lbarone@christianacare.org
Philadelphia
University of Pennsylvania/Abramson Cancer Center
Contact: Site Public Contact
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Contact: Site Public Contact
TX
Bryan
Saint Joseph Regional Cancer Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
UT
Salt Lake City
Huntsman Cancer Institute/University of Utah
Contact: Site Public Contact
Email: cancerinfo@hci.utah.edu
WA
Aberdeen
Providence Regional Cancer System-Aberdeen
Contact: Site Public Contact
Email: deidre.dillon@providence.org
Bellingham
PeaceHealth Saint Joseph Medical Center
Contact: Site Public Contact
Email: lkey@peacehealth.org
Bremerton
Harrison HealthPartners Hematology and Oncology-Bremerton
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org
Burien
Highline Medical Center-Main Campus
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Centralia
Providence Regional Cancer System-Centralia
Contact: Site Public Contact
Email: deidre.dillon@providence.org
Edmonds
Swedish Cancer Institute-Edmonds
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
Enumclaw
Saint Elizabeth Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Everett
Providence Regional Cancer Partnership
Contact: Site Public Contact
Email: marilyn.birchman@providence.org
Federal Way
Saint Francis Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Issaquah
Swedish Cancer Institute-Issaquah
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
Kennewick
Kadlec Clinic Hematology and Oncology
Contact: Site Public Contact
Email: research@kadlecmed.org
Lacey
Providence Regional Cancer System-Lacey
Contact: Site Public Contact
Email: deidre.dillon@providence.org
Lakewood
Saint Clare Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Longview
PeaceHealth Saint John Medical Center
Contact: Site Public Contact
Email: kmakin-bond@peacehealth.org
Poulsbo
Harrison HealthPartners Hematology and Oncology-Poulsbo
Contact: Site Public Contact
Email: clinicaltrials@sfmc-gi.org
Seattle
Pacific Gynecology Specialists
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
Swedish Medical Center-Ballard Campus
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
Swedish Medical Center-Cherry Hill
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
Swedish Medical Center-First Hill
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
Sedro-Woolley
PeaceHealth United General Medical Center
Contact: Site Public Contact
Email: lkey@peacehealth.org
Shelton
Providence Regional Cancer System-Shelton
Contact: Site Public Contact
Email: deidre.dillon@providence.org
Silverdale
Saint Michael Cancer Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Tacoma
Franciscan Research Center-Northwest Medical Plaza
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Vancouver
PeaceHealth Southwest Medical Center
Contact: Site Public Contact
Email: kmakin-bond@peacehealth.org
Walla Walla
Providence Saint Mary Regional Cancer Center
Contact: Site Public Contact
Email: Cheryl.Dodd@providence.org
Yelm
Providence Regional Cancer System-Yelm
Contact: Site Public Contact
Email: deidre.dillon@providence.org
WI
Chippewa Falls
Marshfield Clinic-Chippewa Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Eau Claire
Marshfield Medical Center-EC Cancer Center
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Email: oncology.clinical.trials@marshfieldresearch.org
Ladysmith
Marshfield Medical Center - Ladysmith
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Email: oncology.clinical.trials@marshfieldresearch.org
Marshfield
Marshfield Medical Center-Marshfield
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Email: oncology.clinical.trials@marshfieldresearch.org
Minocqua
Marshfield Clinic-Minocqua Center
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Email: oncology.clinical.trials@marshfieldresearch.org
Rice Lake
Marshfield Medical Center-Rice Lake
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Email: oncology.clinical.trials@marshfieldresearch.org
Stevens Point
Marshfield Medical Center-River Region at Stevens Point
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Email: oncology.clinical.trials@marshfieldresearch.org
Wausau
Marshfield Clinic-Wausau Center
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Email: oncology.clinical.trials@marshfieldresearch.org
Weston
Marshfield Medical Center - Weston
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Email: oncology.clinical.trials@marshfieldresearch.org
Wisconsin Rapids
Marshfield Clinic - Wisconsin Rapids Center
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Email: oncology.clinical.trials@marshfieldresearch.org
PRIMARY OBJECTIVE: I. To determine the rate of one year progression-free survival (PFS) when hydroxychloroquine sulfate (hydroxychloroquine) or placebo is added to dabrafenib mesylate (dabrafenib) and trametinib dimethyl sulfoxide (trametinib) in advanced BRAFV600E/K melanoma with elevated LDH. SECONDARY OBJECTIVES: I. To compare the PFS of both arms. II. To evaluate the best overall response rate by treatment arm. III. To evaluate the complete response (CR) rate by treatment arm. IV. To evaluate the adverse event rate by treatment arm. V. To evaluate overall survival (OS) by treatment arm. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive dabrafenib mesylate orally (PO) twice daily (BID), trametinib dimethyl sulfoxide PO once daily (QD), and hydroxychloroquine sulfate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive dabrafenib mesylate PO BID, trametinib dimethyl sulfoxide PO QD, and placebo PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 1 year.
Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.
The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network.