Radiation Use During Vemurafenib Treatment

Stage IV Melanoma Clinical Trial

Official title:

Radiation Use During Vemurafenib and Cobimetinib Treatment in Patients With BRAFV600 Mutated Stage IV or Unresectable Stage III Melanoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01843738
• Other study ID #: HCI64498
• Status: Withdrawn
• Phase: Phase 1
• First received: April 19, 2013
• Last updated: May 22, 2017
• Start date: June 2017
• Est. completion date: August 2022

Study information

• Verified date: May 2017
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Other known NCT identifiers

• NCT02042040

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• BRAFV600 Mutation
• Melanoma
• Stage IV Melanoma

Intervention

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.

Locations

Country	Name	City	State
United States	Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adverse events as a measure of safety and tolerability	To evaluate the safety of radiation combined with vemurafenib treatment in patients with BRAFV600 mutated Stage IV or unresectable Stage III melanoma	36 months
Secondary	Response rate	To evaluate response rates as assessed by RECIST criteria 1.1, at baseline, and at 8 week intervals throughout the study	36 months