RADVAX: A Stratified Phase I/II Dose Escalation Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Metastatic Melanoma
This is a stratified phase I/II study of escalating fractions of stereotactic body
radiotherapy (SBRT) combined with immunotherapy with Ipilimumab for previously untreated or
previously treated metastatic melanoma patients who are aged 18 years or older. Phase I is
stratified by site: bone or lung versus liver or subcutaneous (s.c.) Six patients will be
enrolled per dose cohort. Phase II is stratified by prior treatment:previously untreated
for metastatic disease versus previously treated for metastatic disease. In phase II, 14
patients will be treated at the MTD (maximum tolerated dose) in each stratum of which phase
I patients treated at the site specific MTD will be included. Descriptive statistics will
be generated for both phases of the study.
Interventional
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
Dose-limiting toxicity (DLT)
30 days
Yes
Ramesh Rengan, MD
Principal Investigator
Abramson Cancer Center of the University of Pennsylvania
United States: Institutional Review Board
UPCC 06611
NCT01497808
December 2011
June 2014
Name | Location |
---|---|
Abramson Cancer Center of the Universirty of Pennsylvania | Philadelphia, Pennsylvania 19104 |