Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    8608507 [PUBMED-IDS]

Phase I Study of Ipilimumab Combined With Whole Brain Radiation Therapy or Radiosurgery for Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01703507
Recruitment Status : Completed
First Posted : October 10, 2012
Results First Posted : August 19, 2019
Last Update Posted : August 19, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Melanoma
Stage IV Melanoma
Tumors Metastatic to Brain
Interventions Drug: Ipilimumab
Radiation: Whole-Brain Radiation Therapy (WBRT)
Radiation: Stereotactic Radiosurgery (SRS)
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm A (Ipilimumab and Whole Brain Radiation Therapy) Arm B (Ipilimumab and Stereotactic Radiosurgery)
Hide Arm/Group Description

Patients receive ipilimumab IV over 90 minutes once in weeks 1, 4, 7, and 10. Patients also undergo WBRT 5 days a week in weeks 1-2.

Ipilimumab: Given IV

Whole-Brain Radiation Therapy (WBRT): Undergo WBRT

Patients receive ipilimumab IV over 90 minutes as in Arm A. Patients also undergo SRS on day 1 in week 1.

Ipilimumab: Given IV

Stereotactic Radiosurgery (SRS): Undergo SRS

Period Title: Overall Study
Started 6 11
Completed 5 11
Not Completed 1 0
Arm/Group Title Arm A (Ipilimumab and Whole Brain Radiation Therapy) Arm B (Ipilimumab and Stereotactic Radiosurgery) Total
Hide Arm/Group Description

Patients receive ipilimumab IV over 90 minutes once in weeks 1, 4, 7, and 10. Patients also undergo WBRT 5 days a week in weeks 1-2.

Ipilimumab: Given IV

Whole-Brain Radiation Therapy (WBRT): Undergo WBRT

Patients receive ipilimumab IV over 90 minutes as in Arm A. Patients also undergo SRS on day 1 in week 1.

Ipilimumab: Given IV

Stereotactic Radiosurgery (SRS): Undergo SRS

Total of all reporting groups
Overall Number of Baseline Participants 6 11 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 11 participants 17 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  16.7%
8
  72.7%
9
  52.9%
>=65 years
5
  83.3%
3
  27.3%
8
  47.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 11 participants 17 participants
Female
2
  33.3%
3
  27.3%
5
  29.4%
Male
4
  66.7%
8
  72.7%
12
  70.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 11 participants 17 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
6
 100.0%
11
 100.0%
17
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 11 participants 17 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
6
 100.0%
11
 100.0%
17
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 11 participants 17 participants
6 11 17
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) of Ipilimumab
Hide Description (MTD) when combined with WBRT or SRS, defined as the last dose studied or the previous dose, based on clinical judgment of the degree of toxicity seen at the last dose
Time Frame 30 days following the completion of radiation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Ipilimumab and Whole Brain Radiation Therapy) Arm B (Ipilimumab and Stereotactic Radiosurgery)
Hide Arm/Group Description:

Patients receive ipilimumab IV over 90 minutes once in weeks 1, 4, 7, and 10. Patients also undergo WBRT 5 days a week in weeks 1-2.

Ipilimumab: Given IV

Whole-Brain Radiation Therapy (WBRT): Undergo WBRT

Patients receive ipilimumab IV over 90 minutes as in Arm A. Patients also undergo SRS on day 1 in week 1.

Ipilimumab: Given IV

Stereotactic Radiosurgery (SRS): Undergo SRS

Overall Number of Participants Analyzed 5 11
Measure Type: Number
Unit of Measure: mg/kg
3 10
2.Secondary Outcome
Title Rate of Developing New Brain Metastases in Each Arm
Hide Description [Not Specified]
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Of the enrolled participants, only 7 developed new Brain Metastases (BMs) and were included in this analysis.
Arm/Group Title Arm A (Ipilimumab and Whole Brain Radiation Therapy) Arm B (Ipilimumab and Stereotactic Radiosurgery)
Hide Arm/Group Description:

Patients receive ipilimumab IV over 90 minutes once in weeks 1, 4, 7, and 10. Patients also undergo WBRT 5 days a week in weeks 1-2.

Ipilimumab: Given IV

Whole-Brain Radiation Therapy (WBRT): Undergo WBRT

Patients receive ipilimumab IV over 90 minutes as in Arm A. Patients also undergo SRS on day 1 in week 1.

Ipilimumab: Given IV

Stereotactic Radiosurgery (SRS): Undergo SRS

Overall Number of Participants Analyzed 1 6
Median (Full Range)
Unit of Measure: months
8.2
(8.2 to 8.2)
1.9
(0.97 to 8.2)
3.Secondary Outcome
Title Response of Extracranial Disease
Hide Description Extracranial disease is assessed through repeated computed tomography of the chest, abdomen, and pelvis. The purpose of this scan is to determine if there is any evidence of disease outside of the brain.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Of the enrolled participants, only 4 out of 5 participants on Arm A and 9 out of 11 participants on Arm B had Extracranial Disease. Only these participants were included in this analysis
Arm/Group Title Arm A (Ipilimumab and Whole Brain Radiation Therapy) Arm B (Ipilimumab and Stereotactic Radiosurgery)
Hide Arm/Group Description:

Patients receive ipilimumab IV over 90 minutes once in weeks 1, 4, 7, and 10. Patients also undergo WBRT 5 days a week in weeks 1-2.

Ipilimumab: Given IV

Whole-Brain Radiation Therapy (WBRT): Undergo WBRT

Patients receive ipilimumab IV over 90 minutes as in Arm A. Patients also undergo SRS on day 1 in week 1.

Ipilimumab: Given IV

Stereotactic Radiosurgery (SRS): Undergo SRS

Overall Number of Participants Analyzed 4 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
5
  55.6%
4.Secondary Outcome
Title Overall Survival (OS) Rate
Hide Description [Not Specified]
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Ipilimumab and Whole Brain Radiation Therapy) Arm B (Ipilimumab and Stereotactic Radiosurgery)
Hide Arm/Group Description:

Patients receive ipilimumab IV over 90 minutes once in weeks 1, 4, 7, and 10. Patients also undergo WBRT 5 days a week in weeks 1-2.

Ipilimumab: Given IV

Whole-Brain Radiation Therapy (WBRT): Undergo WBRT

Patients receive ipilimumab IV over 90 minutes as in Arm A. Patients also undergo SRS on day 1 in week 1.

Ipilimumab: Given IV

Stereotactic Radiosurgery (SRS): Undergo SRS

Overall Number of Participants Analyzed 5 11
Median (Full Range)
Unit of Measure: months
8
(3.5 to 24.1)
10.5
(1.8 to 36.8)
5.Secondary Outcome
Title Progression Free Survival (PFS) Rate
Hide Description PFS rate based on Response Evaluation Criteria in Solid Tumors (RECIST) and immune-related response criteria (irRC) criteria based on the brain MRI and systematic assessment by the treating physician
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Ipilimumab and Whole Brain Radiation Therapy) Arm B (Ipilimumab and Stereotactic Radiosurgery)
Hide Arm/Group Description:

Patients receive ipilimumab IV over 90 minutes once in weeks 1, 4, 7, and 10. Patients also undergo WBRT 5 days a week in weeks 1-2.

Ipilimumab: Given IV

Whole-Brain Radiation Therapy (WBRT): Undergo WBRT

Patients receive ipilimumab IV over 90 minutes as in Arm A. Patients also undergo SRS on day 1 in week 1.

Ipilimumab: Given IV

Stereotactic Radiosurgery (SRS): Undergo SRS

Overall Number of Participants Analyzed 5 11
Measure Type: Count of Participants
Unit of Measure: Participants
3
  60.0%
3
  27.3%
6.Secondary Outcome
Title Number of Participants With Adverse Events and Serious Adverse Events
Hide Description [Not Specified]
Time Frame 4 weeks following the last dose of ipilimumab
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Ipilimumab and Whole Brain Radiation Therapy) Arm B (Ipilimumab and Stereotactic Radiosurgery)
Hide Arm/Group Description:

Patients receive ipilimumab IV over 90 minutes once in weeks 1, 4, 7, and 10. Patients also undergo WBRT 5 days a week in weeks 1-2.

Ipilimumab: Given IV

Whole-Brain Radiation Therapy (WBRT): Undergo WBRT

Patients receive ipilimumab IV over 90 minutes as in Arm A. Patients also undergo SRS on day 1 in week 1.

Ipilimumab: Given IV

Stereotactic Radiosurgery (SRS): Undergo SRS

Overall Number of Participants Analyzed 5 11
Measure Type: Count of Participants
Unit of Measure: Participants
1
  20.0%
4
  36.4%
Time Frame 30 days after completion of radiation therapy (RT)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A (Ipilimumab and Whole Brain Radiation Therapy) Arm B (Ipilimumab and Stereotactic Radiosurgery)
Hide Arm/Group Description

Patients receive ipilimumab IV over 90 minutes once in weeks 1, 4, 7, and 10. Patients also undergo WBRT 5 days a week in weeks 1-2.

Ipilimumab: Given IV

Whole-Brain Radiation Therapy (WBRT): Undergo WBRT

Patients receive ipilimumab IV over 90 minutes as in Arm A. Patients also undergo SRS on day 1 in week 1.

Ipilimumab: Given IV

Stereotactic Radiosurgery (SRS): Undergo SRS

All-Cause Mortality
Arm A (Ipilimumab and Whole Brain Radiation Therapy) Arm B (Ipilimumab and Stereotactic Radiosurgery)
Affected / at Risk (%) Affected / at Risk (%)
Total   3/5 (60.00%)      3/11 (27.27%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm A (Ipilimumab and Whole Brain Radiation Therapy) Arm B (Ipilimumab and Stereotactic Radiosurgery)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/5 (20.00%)      4/11 (36.36%)    
Gastrointestinal disorders     
diarrhea *  1/5 (20.00%)  1 4/11 (36.36%)  4
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A (Ipilimumab and Whole Brain Radiation Therapy) Arm B (Ipilimumab and Stereotactic Radiosurgery)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/5 (40.00%)      4/11 (36.36%)    
Blood and lymphatic system disorders     
Lymphopenia *  0/5 (0.00%)  1/11 (9.09%) 
Anemia *  1/5 (20.00%)  1/11 (9.09%) 
Thrombocytopenia *  0/5 (0.00%)  1/11 (9.09%) 
Ear and labyrinth disorders     
Changes in Hearing *  2/5 (40.00%)  1/11 (9.09%) 
Eye disorders     
Vision Changes *  0/5 (0.00%)  1/11 (9.09%) 
Gastrointestinal disorders     
Diarrhea *  2/5 (40.00%)  3/11 (27.27%) 
Constipation *  1/5 (20.00%)  0/11 (0.00%) 
General disorders     
headache *  2/5 (40.00%)  4/11 (36.36%) 
fatigue *  1/5 (20.00%)  1/11 (9.09%) 
hot flashes *  1/5 (20.00%)  0/11 (0.00%) 
Alopecia *  2/5 (40.00%)  0/11 (0.00%) 
Dizziness *  1/5 (20.00%)  0/11 (0.00%) 
Depression *  0/5 (0.00%)  1/11 (9.09%) 
Weakness *  0/5 (0.00%)  1/11 (9.09%) 
Pleural effusion *  0/5 (0.00%)  1/11 (9.09%) 
Hepatobiliary disorders     
Lipase Increase *  0/5 (0.00%)  1/11 (9.09%) 
Metabolism and nutrition disorders     
Anoerexia *  2/5 (40.00%)  1/11 (9.09%) 
Musculoskeletal and connective tissue disorders     
Bone Pain *  1/5 (20.00%)  0/11 (0.00%) 
Nervous system disorders     
Seizure *  0/5 (0.00%)  1/11 (9.09%) 
Facial Palsy *  0/5 (0.00%)  1/11 (9.09%) 
Vascular disorders     
hypertension *  2/5 (40.00%)  0/11 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Wenyin Shi
Organization: Sidney Kimmel Cancer Center at Thomas Jefferson University
Phone: 215-955-6702
EMail: Wenyin.Shi@jefferson.edu
Publications:
Layout table for additonal information
Responsible Party: Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
ClinicalTrials.gov Identifier: NCT01703507     History of Changes
Other Study ID Numbers: 12P.314
2012-43 ( Other Identifier: CCRRC )
First Submitted: October 5, 2012
First Posted: October 10, 2012
Results First Submitted: April 30, 2019
Results First Posted: August 19, 2019
Last Update Posted: August 19, 2019