Radiation Use During Vemurafenib Treatment

NCT01843738 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: HCI64498
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

BRAFV600 Mutation; Stage IV Melanoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Response rate

  36 months

Study Arms (1)

All participants

EXPERIMENTAL

Radiation: Radiation therapy; Drug: Vemurafenib

Interventions

Radiation therapy RADIATION

Per standard of care

All participants

Vemurafenib DRUG

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

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Radiotherapy; Vemurafenib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kenneth Grossmann, MD, PhD

  Huntsman Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2013
• First Posted: May 1, 2013
• Study Start: June 1, 2017
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: May 24, 2017

Record last verified: 2017-05

Locations

US (1)