Clinical Trial - NCT03224767

Vemurafenib and Cobimetinib in Treating Patients With BRAF V600E Mutation Positive Craniopharyngioma

Recruiting

Sponsor: Alliance for Clinical Trials in Oncology

Collaborators: National Cancer Institute (NCI)

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03224767

Protocol Info

Short Description: Phase II BRAF/MEK Inhibitors in Papillary Craniopharyngiomas
Long Description: Phase II Trial of BRAF/MEK Inhibitors in Papillary Craniopharyngiomas
MGH Status: Open
Sponsor: [Alliance] - formerly CALGB, ACOSOG, and NCCTG
Disease Program: Brain/CNS

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

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.
Condition Title Intervention Phase
BRAF V600E Mutation Present Papillary Craniopharyngioma Vemurafenib Cobimetinib Laboratory Biomarker Analysis Quality-of-Life Assessment Phase 2
Study Type Interventional
Official Title Phase II Trial of BRAF/MEK Inhibitors in Papillary Craniopharyngiomas

Primary Outcome Measures

Response rate [Time Frame: Up to 5 years] [Designated as safety issue: ]


Secondary Outcome Measures

Progression-free survival [Time Frame: Up to 5 years] [Designated as safety issue: ]

Overall survival [Time Frame: Up to 5 years] [Designated as safety issue: ]

Estimated Enrollment: 36
Study Start Date: August 2017
Estimated Study Completion Date: August 2026
Estimated Primary Completion Date: December 2021
Arms Assigned Interventions

Experimental:Treatment (vemurafenib, cobimetinib)

Patients receive vemurafenib PO BID on day 1-28 and cobimetinib PO 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.
Other:Quality-of-Life Assessment
Ancillary studies

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

- 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03224767

Locations

  • United States, Alabama
    • University of Alabama at Birmingham Cancer Center Birmingham, Alabama, United States, 35233
  • United States, California
    • Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn, California, United States, 95603
    • Alta Bates Summit Medical Center-Herrick Campus Berkeley, California, United States, 94704
    • Mills-Peninsula Medical Center Burlingame, California, United States, 94010
    • Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park, California, United States, 95682
    • Eden Hospital Medical Center Castro Valley, California, United States, 94546
    • Memorial Medical Center Modesto, California, United States, 95355
    • Palo Alto Medical Foundation-Camino Division Mountain View, California, United States, 94040
    • UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California, United States, 92868
    • Palo Alto Medical Foundation Health Care Palo Alto, California, United States, 94301
    • Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville, California, United States, 95661
    • Sutter Roseville Medical Center Roseville, California, United States, 95661
    • Sutter Medical Center Sacramento Sacramento, California, United States, 95816
    • California Pacific Medical Center-Pacific Campus San Francisco, California, United States, 94115
    • Palo Alto Medical Foundation-Sunnyvale Sunnyvale, California, United States, 94086
    • Sutter Cancer Centers Radiation Oncology Services-Vacaville Vacaville, California, United States, 95687
    • Sutter Solano Medical Center/Cancer Center Vallejo, California, United States, 94589
  • United States, Florida
    • University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida, United States, 33136
  • United States, Idaho
    • Saint Alphonsus Cancer Care Center-Boise Boise, Idaho, United States, 83706
    • Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho, United States, 83605
    • Kootenai Medical Center Coeur d'Alene, Idaho, United States, 83814
    • Idaho Urologic Institute-Meridian Meridian, Idaho, United States, 83642
    • Kootenai Cancer Center Post Falls, Idaho, United States, 83854
  • United States, Illinois
    • Rush University Medical Center Chicago, Illinois, United States, 60612
  • United States, Kansas
    • Central Care Cancer Center - Garden City Garden City, Kansas, United States, 67846
    • Central Care Cancer Center - Great Bend Great Bend, Kansas, United States, 67530
  • United States, Maryland
    • Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland, United States, 21287
  • United States, Massachusetts
    • Massachusetts General Hospital Cancer Center Boston, Massachusetts, United States, 02114
    • Dana-Farber Cancer Institute Boston, Massachusetts, United States, 02215
  • United States, Michigan
    • University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan, United States, 48109
    • Bronson Battle Creek Battle Creek, Michigan, United States, 49017
    • Helen DeVos Children's Hospital at Spectrum Health Grand Rapids, Michigan, United States, 49503
    • Mercy Health Saint Mary's Grand Rapids, Michigan, United States, 49503
    • Spectrum Health at Butterworth Campus Grand Rapids, Michigan, United States, 49503
    • Bronson Methodist Hospital Kalamazoo, Michigan, United States, 49007
    • West Michigan Cancer Center Kalamazoo, Michigan, United States, 49007
    • Borgess Medical Center Kalamazoo, Michigan, United States, 49048
    • Mercy Health Mercy Campus Muskegon, Michigan, United States, 49444
    • Lakeland Hospital Niles Niles, Michigan, United States, 49120
    • Spectrum Health Reed City Hospital Reed City, Michigan, United States, 49677
    • Lakeland Medical Center Saint Joseph Saint Joseph, Michigan, United States, 49085
    • Marie Yeager Cancer Center Saint Joseph, Michigan, United States, 49085
    • Munson Medical Center Traverse City, Michigan, United States, 49684
    • Metro Health Hospital Wyoming, Michigan, United States, 49519
  • United States, Minnesota
    • Fairview Ridges Hospital Burnsville, Minnesota, United States, 55337
    • Mercy Hospital Coon Rapids, Minnesota, United States, 55433
    • Fairview-Southdale Hospital Edina, Minnesota, United States, 55435
    • Unity Hospital Fridley, Minnesota, United States, 55432
    • Fairview Maple Grove Medical Center Maple Grove, Minnesota, United States, 55369
    • Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota, United States, 55109
    • Saint John's Hospital - Healtheast Maplewood, Minnesota, United States, 55109
    • Abbott-Northwestern Hospital Minneapolis, Minnesota, United States, 55407
    • Hennepin County Medical Center Minneapolis, Minnesota, United States, 55415
    • Health Partners Inc Minneapolis, Minnesota, United States, 55454
    • Monticello Cancer Center Monticello, Minnesota, United States, 55362
    • North Memorial Medical Health Center Robbinsdale, Minnesota, United States, 55422
    • Mayo Clinic Rochester, Minnesota, United States, 55905
    • Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota, United States, 55416
    • Regions Hospital Saint Paul, Minnesota, United States, 55101
    • United Hospital Saint Paul, Minnesota, United States, 55102
    • Saint Francis Regional Medical Center Shakopee, Minnesota, United States, 55379
    • Lakeview Hospital Stillwater, Minnesota, United States, 55082
    • Ridgeview Medical Center Waconia, Minnesota, United States, 55387
    • Rice Memorial Hospital Willmar, Minnesota, United States, 56201
    • Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota, United States, 55125
  • United States, Missouri
    • Central Care Cancer Center - Bolivar Bolivar, Missouri, United States, 65613
    • Research Medical Center Kansas City, Missouri, United States, 64132
    • Washington University School of Medicine Saint Louis, Missouri, United States, 63110
  • United States, Montana
    • Billings Clinic Cancer Center Billings, Montana, United States, 59101
    • Bozeman Deaconess Hospital Bozeman, Montana, United States, 59715
    • Benefis Healthcare- Sletten Cancer Institute Great Falls, Montana, United States, 59405
    • Kalispell Regional Medical Center Kalispell, Montana, United States, 59901
    • Community Medical Hospital Missoula, Montana, United States, 59804
  • United States, New Hampshire
    • Dartmouth Hitchcock Medical Center Lebanon, New Hampshire, United States, 03756
  • United States, New Jersey
    • Rutgers New Jersey Medical School Newark, New Jersey, United States, 07101
  • United States, New York
    • NYP/Weill Cornell Medical Center New York, New York, United States, 10065
  • United States, North Carolina
    • UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina, United States, 27599
    • Wake Forest University Health Sciences Winston-Salem, North Carolina, United States, 27157
  • United States, Texas
    • M D Anderson Cancer Center Houston, Texas, United States, 77030
  • United States, Utah
    • Farmington Health Center Farmington, Utah, United States, 84025
    • Huntsman Cancer Institute/University of Utah Salt Lake City, Utah, United States, 84112
    • South Jordan Health Center South Jordan, Utah, United States, 84009
  • United States, Washington
    • Fred Hutchinson Cancer Research Center Seattle, Washington, United States, 98109
    • Seattle Cancer Care Alliance Seattle, Washington, United States, 98109
    • University of Washington Medical Center Seattle, Washington, United States, 98195
  • United States, Wisconsin
    • Aurora Saint Luke's Medical Center Milwaukee, Wisconsin, United States, 53215
    • Cancer Center of Western Wisconsin New Richmond, Wisconsin, United States, 54017

Sponsors and Collaborators

Alliance for Clinical Trials in Oncology

National Cancer Institute (NCI)

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03224767
Other Study ID Numbers: NCI-2017-00740
Study First Received:
Last Updated:
Health Authority:

Additional relevant MeSH terms:

Craniopharyngioma

Adamantinoma

Vemurafenib

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on August 15, 2019