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

Sponsor
Abramson Cancer Center of the University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT01497808
Collaborator
(none)
22
Enrollment
1
Location
4
Arms
46.4
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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 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

Condition or DiseaseIntervention/TreatmentPhase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
RADVAX™: A STRATIFIED PHASE I/II DOSE ESCALATION TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOLLOWED BY IPILIMUMAB IN METASTATIC MELANOMA
Actual Study Start Date :
Nov 29, 2011
Actual Primary Completion Date :
Dec 29, 2013
Actual Study Completion Date :
Oct 12, 2015

Arms and Interventions

ArmIntervention/Treatment
Experimental: Ipilimumab and Radiotherapy (8 Gy x 2)

Drug: Ipilimumab

Radiation: Stereotactic Body Radiation Therapy

Experimental: Ipilimumab and Radiotherapy (8 Gy x 3)

Drug: Ipilimumab

Radiation: Stereotactic Body Radiation Therapy

Experimental: Ipilimumab and Radiotherapy (6 Gy x 2)

Drug: Ipilimumab

Radiation: Stereotactic Body Radiation Therapy

Experimental: Ipilimumab and Radiotherapy (6 Gy x 3)

Drug: Ipilimumab

Radiation: Stereotactic Body Radiation Therapy

Outcome Measures

Primary Outcome Measures

  1. Dose-limiting Toxicity (DLT) [30 days]

Secondary Outcome Measures

  1. Participants With Adverse Events [after 30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Abramson Cancer Center of the Universirty of PennsylvaniaPhiladelphiaPennsylvaniaUnited States19104

Sponsors and Collaborators

  • Abramson Cancer Center of the University of Pennsylvania

Investigators

  • Principal Investigator: Amit Maity, PhD, Abramson Cancer Center of the University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01497808
Other Study ID Numbers:
  • UPCC 06611
First Posted:
Dec 23, 2011
Last Update Posted:
Aug 10, 2021
Last Verified:
Jul 1, 2021
Keywords provided by Abramson Cancer Center of the University of Pennsylvania
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleIpilimumab and Radiotherapy (8 Gy x 2)Ipilimumab and Radiotherapy (8 Gy x 3)Ipilimumab and Radiotherapy (6 Gy x 2)Ipilimumab and Radiotherapy (6 Gy x 3)
Arm/Group DescriptionIpilimumab Stereotactic Body Radiation Therapy
Period Title: Overall Study
STARTED6466
COMPLETED6466
NOT COMPLETED0000

Baseline Characteristics

Arm/Group TitleIpilimumab and Radiotherapy (8 Gy x 2)Ipilimumab and Radiotherapy (8 Gy x 3)Ipilimumab and Radiotherapy (6 Gy x 2)Ipilimumab and Radiotherapy (6 Gy x 3)Total
Arm/Group DescriptionIpilimumab Stereotactic Body Radiation TherapyTotal of all reporting groups
Overall Participants646622
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
0
0%
0
0%
Between 18 and 65 years
3
50%
3
75%
2
33.3%
0
0%
8
36.4%
>=65 years
3
50%
1
25%
4
66.7%
6
100%
14
63.6%
Sex: Female, Male (Count of Participants)
Female
1
16.7%
2
50%
1
16.7%
1
16.7%
5
22.7%
Male
5
83.3%
2
50%
5
83.3%
5
83.3%
17
77.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
0
0%
0
0%
0
0%
0
0%
0
0%
Not Hispanic or Latino
6
100%
4
100%
6
100%
6
100%
22
100%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
0
0%
0
0%
Black or African American
0
0%
0
0%
0
0%
0
0%
0
0%
White
6
100%
4
100%
6
100%
6
100%
22
100%
More than one race
0
0%
0
0%
0
0%
0
0%
0
0%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
0
0%

Outcome Measures

1. Primary Outcome
TitleDose-limiting Toxicity (DLT)
Description
Time Frame30 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleIpilimumab and Radiotherapy (8 Gy x 2)Ipilimumab and Radiotherapy (8 Gy x 3)Ipilimumab and Radiotherapy (6 Gy x 2)Ipilimumab and Radiotherapy (6 Gy x 3)
Arm/Group DescriptionIpilimumab Stereotactic Body Radiation Therapy
Measure Participants6466
Count of Participants [Participants]
0
0%
0
0%
0
0%
0
0%
2. Secondary Outcome
TitleParticipants With Adverse Events
Description
Time Frameafter 30 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleIpilimumab and Radiotherapy (8 Gy x 2)Ipilimumab and Radiotherapy (8 Gy x 3)Ipilimumab and Radiotherapy (6 Gy x 2)Ipilimumab and Radiotherapy (6 Gy x 3)
Arm/Group DescriptionIpilimumab Stereotactic Body Radiation Therapy
Measure Participants6466
Count of Participants [Participants]
6
100%
4
100%
6
100%
6
100%

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group TitleIpilimumab and Radiotherapy (8 Gy x 2)Ipilimumab and Radiotherapy (8 Gy x 3)Ipilimumab and Radiotherapy (6 Gy x 2)Ipilimumab and Radiotherapy (6 Gy x 3)
Arm/Group Description
All Cause Mortality
Ipilimumab and Radiotherapy (8 Gy x 2)Ipilimumab and Radiotherapy (8 Gy x 3)Ipilimumab and Radiotherapy (6 Gy x 2)Ipilimumab and Radiotherapy (6 Gy x 3)
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/6 (0%) 0/4 (0%) 0/6 (0%) 0/6 (0%)
Serious Adverse Events
Ipilimumab and Radiotherapy (8 Gy x 2)Ipilimumab and Radiotherapy (8 Gy x 3)Ipilimumab and Radiotherapy (6 Gy x 2)Ipilimumab and Radiotherapy (6 Gy x 3)
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total5/6 (83.3%) 1/4 (25%) 3/6 (50%) 2/6 (33.3%)
Blood and lymphatic system disorders
Anemia1/6 (16.7%) 0/4 (0%) 1/6 (16.7%) 0/6 (0%)
Gastrointestinal disorders
Gastric hemorrhage0/6 (0%) 0/4 (0%) 1/6 (16.7%) 0/6 (0%)
General disorders
4/6 (66.7%) 1/4 (25%) 2/6 (33.3%) 2/6 (33.3%)
Immune system disorders
Cytokine release syndrome1/6 (16.7%) 0/4 (0%) 0/6 (0%) 0/6 (0%)
Infections and infestations
Wound infection1/6 (16.7%) 0/4 (0%) 0/6 (0%) 0/6 (0%)
Vascular disorders
Hypotension1/6 (16.7%) 0/4 (0%) 0/6 (0%) 0/6 (0%)
Other (Not Including Serious) Adverse Events
Ipilimumab and Radiotherapy (8 Gy x 2)Ipilimumab and Radiotherapy (8 Gy x 3)Ipilimumab and Radiotherapy (6 Gy x 2)Ipilimumab and Radiotherapy (6 Gy x 3)
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total5/6 (83.3%) 3/4 (75%) 6/6 (100%) 6/6 (100%)
Gastrointestinal disorders
Nausea2/6 (33.3%) 0/4 (0%) 0/6 (0%) 0/6 (0%)
Stomach pain1/6 (16.7%) 0/4 (0%) 1/6 (16.7%) 0/6 (0%)
General disorders
Edema limbs2/6 (33.3%) 0/4 (0%) 0/6 (0%) 0/6 (0%)
Fatigue2/6 (33.3%) 0/4 (0%) 2/6 (33.3%) 0/6 (0%)
4/6 (66.7%) 3/4 (75%) 6/6 (100%) 6/6 (100%)
Metabolism and nutrition disorders
Anorexia1/6 (16.7%) 0/4 (0%) 0/6 (0%) 0/6 (0%)
Respiratory, thoracic and mediastinal disorders
Cough1/6 (16.7%) 0/4 (0%) 1/6 (16.7%) 0/6 (0%)
Dyspnea2/6 (33.3%) 0/4 (0%) 1/6 (16.7%) 0/6 (0%)
Skin and subcutaneous tissue disorders
Pruritus1/6 (16.7%) 0/4 (0%) 1/6 (16.7%) 0/6 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleDr. Amit Maity
OrganizationUniversity of Pennsylvania
Phone(215) 615-6767
Emailmaity@uphs.upenn.edu
Responsible Party:
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01497808
Other Study ID Numbers:
  • UPCC 06611
First Posted:
Dec 23, 2011
Last Update Posted:
Aug 10, 2021
Last Verified:
Jul 1, 2021