Status:
COMPLETED
RADVAX™: A STRATIFIED PHASE I/II DOSE ESCALATION TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOLLOWED BY IPILIMUMAB IN METASTATIC MELANOMA
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 29 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2015
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01497808
Start Date
November 29 2011
End Date
October 12 2015
Last Update
August 10 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Abramson Cancer Center of the Universirty of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104