Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Radiation Use During Vemurafenib Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01843738
Recruitment Status : Withdrawn (Competing Trials)
First Posted : May 1, 2013
Last Update Posted : May 24, 2017
Sponsor:
Information provided by (Responsible Party):
University of Utah

Brief Summary:
Patients are being asked to take part because they have melanoma that has spread to other organs in their body (metastatic). As part of this study, patients will receive radiation therapy and an approved drug (Vemurafenib).

Condition or disease Intervention/treatment Phase
BRAFV600 Mutation Stage IV Melanoma Radiation: Radiation therapy Drug: Vemurafenib Phase 1

Detailed Description:
Patients will be treated with vemurafenib plus radiation therapy (RT) based upon the administration schedule. The starting dose of vemurafenib will be the patient's baseline tolerating dose, between 720 - and 960 mg by mouth. Patients must be tolerating at a minimum 720mg for one cycle (28 days) prior to enrollment.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiation Use During Vemurafenib and Cobimetinib Treatment in Patients With BRAFV600 Mutated Stage IV or Unresectable Stage III Melanoma
Estimated Study Start Date : June 2017
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Vemurafenib

Arm Intervention/treatment
Experimental: All participants Radiation: Radiation therapy
Per standard of care

Drug: Vemurafenib
The starting dose of vemurafenib will be the patient's baseline tolerating dose, between 720 - and 960 mg PO bid.




Primary Outcome Measures :
  1. Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 36 months ]
    To evaluate the safety of radiation combined with vemurafenib treatment in patients with BRAFV600 mutated Stage IV or unresectable Stage III melanoma


Secondary Outcome Measures :
  1. Response rate [ Time Frame: 36 months ]
    To evaluate response rates as assessed by RECIST criteria 1.1, at baseline, and at 8 week intervals throughout the study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years old
  • Diagnosis of BRAFV600 mutated Stage IV or unresectable Stage III melanoma
  • Actively receiving treatment with vemurafenib as single agent and tolerating at least 720 mg bid for one cycle (28 days).
  • In the opinion of the investigator, patients who are progressing in an area where radiation may provide benefit from either:

    • Symptom control
    • Oligo-progression, defined as progression in up to 3 areas where focal treatment would provide benefit.
  • Patients with brain metastases will be allowed provided they meet all of the following criteria:

    • Small, < 1cm metastases which are untreated are allowed so long as in the opinion of the investigator they do not require immediate treatment by radiation or surgery
    • Asymptomatic, treated brain metastases which are stable for 4 weeks prior to study entry are allowed
    • If patients are requiring steroids for their brain metastases, they must be on a stable dose for two weeks prior to study entry, and maintain that steroid dosing during the radiation treatments
  • Adequate bone marrow function as defined by: ANC > 1.0 k/uL, Platelets > 75 k/uL, Hemoglobin > 8 g/dL
  • Adequate hepatic function: Total bilirubin < 1.5 times the institutional upper limit of normal, ALT/AST < 2.5 times the institutional upper limit of normal
  • Adequate renal function as defined by serum creatinin < 1.5 times the upper limit of normal.
  • Negative serum pregnancy test at screening for women of child bearing potential within 10 days of starting vemurafenib treatment . Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for > 1 year
  • Fertile men and women must agree to use an acceptable method of birth control during treatment and for at least 2 months after discontinuation of vemurafenib.
  • Able and willing to provide informed consent to an approved consent form that conforms to federal and institutional guidelines.

Exclusion Criteria:

  • Screening QTc interval > 450 msec on EKG
  • Known HIV positivity or AIDS-related illness, or active HBV, or active HCV.
  • Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, serious cardiac arrhythmia requiring medication, uncontrolled hypertension, cerebrovascular accident or transient ischemic attack, or symptomatic pulmonary embolism.
  • Malabsorption disorder that would preclude adequate vemurafenib absorption.
  • Other medical condition present that in the opinion of the investigator will hinder the subjects ability to complete the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01843738


Locations
Layout table for location information
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
Layout table for investigator information
Principal Investigator: Kenneth Grossmann, MD, PhD Huntsman Cancer Institute
Layout table for additonal information
Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01843738    
Obsolete Identifiers: NCT02042040
Other Study ID Numbers: HCI64498
First Posted: May 1, 2013    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: May 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Vemurafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action