RADVAX™: A STRATIFIED PHASE I/II DOSE ESCALATION TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOLLOWED BY IPILIMUMAB IN METASTATIC MELANOMA

Metastatic Melanoma Clinical Trial

Official title:

RADVAX™: A STRATIFIED PHASE I/II DOSE ESCALATION TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOLLOWED BY IPILIMUMAB IN METASTATIC MELANOMA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497808
• Other study ID #: UPCC 06611
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 29, 2011
• Est. completion date: October 12, 2015

Study information

• Verified date: July 2021
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Intervention

Drug:
• Ipilimumab

Radiation:
• Stereotactic Body Radiation Therapy

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the Universirty of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting Toxicity (DLT)		30 days
Secondary	Participants With Adverse Events		after 30 days