Metastatic Melanoma Clinical Trial
Official title:
RADVAX™: A STRATIFIED PHASE I/II DOSE ESCALATION TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOLLOWED BY IPILIMUMAB IN METASTATIC MELANOMA
Verified date | July 2021 |
Source | Abramson Cancer Center of the University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective is to determine the maximum tolerated hypofractionated radiotherapy dose (MTD) to a solitary metastatic focus ('index lesion') when followed by ipilimumab, in metastatic melanoma patients without brain involvement The secondary objectives are to determine late toxicity, immune-related clinical responses and immune pharmacodynamic changes after hypofractionated radiotherapy followed by ipilimumab
Status | Completed |
Enrollment | 22 |
Est. completion date | October 12, 2015 |
Est. primary completion date | December 29, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria - Patient > 18 years old - Histologically confirmed diagnosis of melanoma - Previously treated or previously untreated metastatic melanoma by AJCC staging criteria - Presence of an index lesion > 1 cm amenable to hypofractionated radiotherapy and at least one other additional lesion that can be followed for response using RECIST criteria - ECOG Performance status 0 or 1 - Signed informed consent document - Ability to tolerate stereotactic body radiation therapy (e.g. lie flat and hold position for treatment) Exclusion Criteria - Prior systemic therapy within 14 days of study enrollment. Patients must be adequately recovered from prior systemic therapy side effects as deemed by the PI. - Clinical contraindication to stereotactic body radiotherapy (e.g. active systemic sclerosis, active inflammatory bowel disease if bowel is within target field, etc) - Presence or history of central nervous system metastasis (including brain) - Long-term use of systemic corticosteroids - Prior RT that precludes the delivery of hypofractionated radiotherapy |
Country | Name | City | State |
---|---|---|---|
United States | Abramson Cancer Center of the Universirty of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Abramson Cancer Center of the University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose-limiting Toxicity (DLT) | 30 days | ||
Secondary | Participants With Adverse Events | after 30 days |
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