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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ipilimumab 25 mg

Participants receive ipilimumab intratumorally on Day 1

Ipilimumab: Given intratumorally

Ipilimumab 25 mg and Radiation Therapy

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


Participant Flow:   Overall Study
    Ipilimumab 25 mg   Ipilimumab 25 mg and Radiation Therapy
STARTED   3   0 
COMPLETED   3   0 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ipilimumab 25 mg

Participants receive ipilimumab intratumorally on Day 1

Ipilimumab: Given intratumorally

Ipilimumab 25 mg and Radiation Therapy

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 Total of all reporting groups

Baseline Measures
   Ipilimumab 25 mg   Ipilimumab 25 mg and Radiation Therapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   0   3 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Median (Full Range)
 61 
 (58 to 78) 
    61 
 (58 to 78) 
Gender 
[Units: Participants]
Count of Participants
     
Female      2  66.7%         2  66.7% 
Male      1  33.3%         1  33.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
United States   3      3 


  Outcome Measures

1.  Primary:   Dose-limiting Toxicity   [ Time Frame: 4 weeks ]

2.  Secondary:   Immune Response (Phase 2 Only)   [ Time Frame: 4 weeks ]

3.  Secondary:   Immune Response (Phase 2 Only)   [ Time Frame: 8 weeks ]

4.  Secondary:   Overall Survival (Phase 2 Only)   [ Time Frame: Up to 5 years ]

5.  Secondary:   Duration of Response (Phase 2 Only)   [ Time Frame: Up to 5 years ]

6.  Secondary:   Response Rate (Phase 2 Only)   [ Time Frame: 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   01/2017  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: georgeaf@stanford.edu



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