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Ipilimumab and Local Radiation Therapy in Treating Patients With Recurrent Melanoma, Non-Hodgkin Lymphoma, Colon, or Rectal Cancer

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ClinicalTrials.gov Identifier: NCT01769222
Recruitment Status : Terminated (Planned Future Study)
First Posted : January 16, 2013
Results First Posted : March 3, 2017
Last Update Posted : March 3, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
George Albert Fisher, Stanford University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Nasal Type Extranodal NK/T-cell Lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Cutaneous B-cell Non-Hodgkin Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Hepatosplenic T-cell Lymphoma
Intraocular Lymphoma
Nodal Marginal Zone B-cell Lymphoma
Peripheral T-cell Lymphoma
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Colon Cancer
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Melanoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Recurrent Rectal Cancer
Recurrent Small Lymphocytic Lymphoma
Refractory Hairy Cell Leukemia
Small Intestine Lymphoma
Splenic Marginal Zone Lymphoma
T-cell Large Granular Lymphocyte Leukemia
Testicular Lymphoma
Waldenström Macroglobulinemia
Interventions Biological: Ipilimumab
Radiation: Radiation therapy
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ipilimumab 25 mg Ipilimumab 25 mg and Radiation Therapy
Hide Arm/Group Description

Participants receive ipilimumab intratumorally on Day 1

Ipilimumab: Given intratumorally

Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions

Ipilimumab: Given intratumorally

Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions

Period Title: Overall Study
Started 3 0
Completed 3 0
Not Completed 0 0
Arm/Group Title Ipilimumab 25 mg Ipilimumab 25 mg and Radiation Therapy Total
Hide Arm/Group Description

Participants receive ipilimumab intratumorally on Day 1

Ipilimumab: Given intratumorally

Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions

Ipilimumab: Given intratumorally

Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions

Total of all reporting groups
Overall Number of Baseline Participants 3 0 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 0 participants 3 participants
<=18 years
0
   0.0%
0
0
   0.0%
Between 18 and 65 years
2
  66.7%
0
2
  66.7%
>=65 years
1
  33.3%
0
1
  33.3%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 0 participants 3 participants
61
(58 to 78)
61
(58 to 78)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 0 participants 3 participants
Female
2
  66.7%
2
  66.7%
Male
1
  33.3%
1
  33.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 0 participants 3 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
Not Hispanic or Latino
3
 100.0%
3
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 0 participants 3 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
White
3
 100.0%
3
 100.0%
More than one race
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 3 participants 0 participants 3 participants
3
 100.0%
3
 100.0%
1.Primary Outcome
Title Dose-limiting Toxicity
Hide Description Safety as the percentage of patients experiencing dose-limiting toxicities (DLTs) or serious adverse events (SAEs) using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ipilimumab 25 mg Ipilimumab 25 mg and Radiation Therapy
Hide Arm/Group Description:

Participants receive ipilimumab intratumorally on Day 1

Ipilimumab: Given intratumorally

Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions

Ipilimumab: Given intratumorally

Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions

Overall Number of Participants Analyzed 3 0
Measure Type: Number
Unit of Measure: percentage of participants
0
2.Secondary Outcome
Title Immune Response (Phase 2 Only)
Hide Description Data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ipilimumab 25 mg Ipilimumab 25 mg and Radiation Therapy
Hide Arm/Group Description:

Participants receive ipilimumab intratumorally on Day 1

Ipilimumab: Given intratumorally

Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions

Ipilimumab: Given intratumorally

Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Immune Response (Phase 2 Only)
Hide Description Data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ipilimumab 25 mg Ipilimumab 25 mg and Radiation Therapy
Hide Arm/Group Description:

Participants receive ipilimumab intratumorally on Day 1

Ipilimumab: Given intratumorally

Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions

Ipilimumab: Given intratumorally

Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Response Rate (Phase 2 Only)
Hide Description Response rates calculated based on the Response Evaluation Criteria in Solid Tumors (RECIST)/RECIST Immunotherapy and Cheson criteria (Phase 2 only). Response rate data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.
Time Frame 8 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Overall Survival (Phase 2 Only)
Hide Description Data will be summarized using Kaplan-Meier estimates for time to event data.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ipilimumab 25 mg Ipilimumab 25 mg and Radiation Therapy
Hide Arm/Group Description:

Participants receive ipilimumab intratumorally on Day 1

Ipilimumab: Given intratumorally

Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions

Ipilimumab: Given intratumorally

Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Duration of Response (Phase 2 Only)
Hide Description Data will be summarized using Kaplan-Meier estimates for time to event data.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ipilimumab 25 mg Ipilimumab 25 mg and Radiation Therapy
Hide Arm/Group Description:

Participants receive ipilimumab intratumorally on Day 1

Ipilimumab: Given intratumorally

Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions

Ipilimumab: Given intratumorally

Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ipilimumab 25 mg Ipilimumab 25 mg and Radiation Therapy
Hide Arm/Group Description

Participants receive ipilimumab intratumorally on Day 1

Ipilimumab: Given intratumorally

Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions

Ipilimumab: Given intratumorally

Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions

All-Cause Mortality
Ipilimumab 25 mg Ipilimumab 25 mg and Radiation Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ipilimumab 25 mg Ipilimumab 25 mg and Radiation Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/0    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ipilimumab 25 mg Ipilimumab 25 mg and Radiation Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      0/0    
Skin and subcutaneous tissue disorders     
Pain, injection site  1  1/3 (33.33%)  1 0/0  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 4
Certain Agreements
Principal Investigators are NOT 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/Title: George Albert Fisher, MD
Organization: Stanford University Medical Center
Phone: 650-725-9057
Responsible Party: George Albert Fisher, Stanford University
ClinicalTrials.gov Identifier: NCT01769222     History of Changes
Other Study ID Numbers: IRB-25597
NCI-2012-02988 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
VAR0090 ( Other Identifier: OnCore )
First Submitted: January 14, 2013
First Posted: January 16, 2013
Results First Submitted: January 12, 2017
Results First Posted: March 3, 2017
Last Update Posted: March 3, 2017