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CPG 7909 + Local Radiotherapy in Recurrent Low-Grade Lymphomas

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ClinicalTrials.gov Identifier: NCT00185965
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : August 1, 2014
Last Update Posted : August 1, 2014
Sponsor:
Collaborators:
Lymphoma Research Foundation
American Society of Clinical Oncology
Information provided by (Responsible Party):
Ronald Levy, Stanford University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Non-Hodgkin Lymphoma
Mycosis Fungoides
Intervention Drug: CPG 7909
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lymphoma, B-cell Low-grade (BCL) Mycosis Fungoides (MF)
Hide Arm/Group Description

Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)

CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).

Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)

CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).

Period Title: Overall Study
Started 15 15
Completed 15 14
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
Arm/Group Title Lymphoma, B-cell Low-grade (BCL) Mycosis Fungoides (MF) Total
Hide Arm/Group Description

Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)

CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).

Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)

CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).

Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
62
(38 to 65)
57
(18 to 71)
60
(18 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
5
  33.3%
3
  20.0%
8
  26.7%
Male
10
  66.7%
12
  80.0%
22
  73.3%
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description Objective Response Rate (ORR) consisting of Complete Response (CR) + Partial Response (PR), not including Stable Disease (SD)
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lymphoma, B-cell Low-grade (BCL) Mycosis Fungoides (MF)
Hide Arm/Group Description:

Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)

CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).

Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)

CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).

Overall Number of Participants Analyzed 15 14
Measure Type: Number
Unit of Measure: percentage of treated subjects
26.7 35.7
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lymphoma, B-cell Low-grade (BCL) Mycosis Fungoides (MF)
Hide Arm/Group Description

Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)

CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).

Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)

CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).

All-Cause Mortality
Lymphoma, B-cell Low-grade (BCL) Mycosis Fungoides (MF)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Lymphoma, B-cell Low-grade (BCL) Mycosis Fungoides (MF)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      1/15 (6.67%)    
General disorders     
Injection site reaction  0/15 (0.00%)  0 1/15 (6.67%)  1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lymphoma, B-cell Low-grade (BCL) Mycosis Fungoides (MF)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/15 (33.33%)      15/15 (100.00%)    
Blood and lymphatic system disorders     
Lymphadenopathy  0/15 (0.00%)  0 2/15 (13.33%)  2
Cardiac disorders     
Palpitation  0/15 (0.00%)  0 1/15 (6.67%)  1
Gastrointestinal disorders     
Diarrhea  0/15 (0.00%)  0 4/15 (26.67%)  4
Nausea  0/15 (0.00%)  0 3/15 (20.00%)  3
Vomiting  0/15 (0.00%)  0 1/15 (6.67%)  1
General disorders     
Flu like symptoms  5/15 (33.33%)  5 0/15 (0.00%)  0
Injection site reaction  1/15 (6.67%)  1 14/15 (93.33%)  14
Chills  0/15 (0.00%)  0 14/15 (93.33%)  14
Fatigue  0/15 (0.00%)  0 13/15 (86.67%)  13
Fever  0/15 (0.00%)  0 10/15 (66.67%)  10
Infections and infestations     
Rhinitis infective  0/15 (0.00%)  0 1/15 (6.67%)  1
Musculoskeletal and connective tissue disorders     
Myalgia  0/15 (0.00%)  0 10/15 (66.67%)  10
Arthralgia  0/15 (0.00%)  0 9/15 (60.00%)  9
Nervous system disorders     
Headache  0/15 (0.00%)  0 11/15 (73.33%)  11
Dizziness  0/15 (0.00%)  0 1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  0/15 (0.00%)  0 2/15 (13.33%)  2
Skin and subcutaneous tissue disorders     
Hyperhidrosis  0/15 (0.00%)  0 1/15 (6.67%)  1
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
Layout table for Results Point of Contact information
Name/Title: Ronald Levy, MD / Robert K and Helen K Summy Professor of Medicine
Organization: School of Medicine, Stanford University
Phone: 650-725-6452
EMail: levy@stanford.edu
Layout table for additonal information
Responsible Party: Ronald Levy, Stanford University
ClinicalTrials.gov Identifier: NCT00185965    
Other Study ID Numbers: IRB-13063
80057 ( Other Identifier: Stanford University Alternate IRB Number )
LYMNHL0014 ( Other Identifier: OnCore )
First Submitted: September 12, 2005
First Posted: September 16, 2005
Results First Submitted: July 7, 2014
Results First Posted: August 1, 2014
Last Update Posted: August 1, 2014