Loading clinical trials...
Loading clinical trials...
RADVAX: A Stratified Phase II Dose Escalation Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Metastatic Melanoma
This phase II trial studies how well stereotactic body radiotherapy and ipilimumab work in treating patients with stage IV melanoma. Stereotactic body radiotherapy (SBRT) may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal antibodies, such as ipilimumab, target certain cells to interfere with the ability of tumor cells to grow and spread. Giving SBRT with ipilimumab may kill more tumor cells.
PRIMARY OBJECTIVES: I. To determine feasibility and immune-related clinical responses associated with SBRT when given in conjunction with ipilimumab. SECONDARY OBJECTIVES: I. To determine late toxicity and immune pharmacodynamic changes after SBRT followed by ipilimumab. OUTLINE: Patients undergo a total of 3 fractions of stereotactic body radiotherapy between days 1-13. Patients then receive ipilimumab intravenously (IV) every 3 weeks. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up within 60 days, and then every effort will be made to obtain records of patients during this follow up, and permission will be sought for the investigators and/or study team to re-contact the patient directly with regard to health status and toxicity.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Start Date
March 1, 2014
Primary Completion Date
November 3, 2018
Completion Date
June 21, 2019
Last Updated
February 13, 2020
23
ACTUAL participants
Ipilimumab
BIOLOGICAL
Laboratory Biomarker Analysis
OTHER
Pharmacological Study
OTHER
Stereotactic Body Radiation Therapy
RADIATION
Lead Sponsor
University of Washington
Collaborators
NCT01303341
NCT00937937
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions