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Phase II Study of Allo LMI Vaccine With IL-2 for Stable Metastatic Breast Ca

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ClinicalTrials.gov Identifier: NCT00784524
Recruitment Status : Terminated (Slow accrual)
First Posted : November 4, 2008
Results First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Biological: allogeneic large multivalent immunogen breast cancer vaccine
Biological: aldesleukin
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LMI Vaccination + IL-2
Hide Arm/Group Description

Patients receiving allogeneic large multivalent immunogen breast cancer vaccine and aldesleukin.

allogeneic large multivalent immunogen breast cancer vaccine: Allogeneic large multivalent immunogen breast cancer vaccine (1 x 10^7, 5-μm silica spheres) will be given as an intradermal injection every 28 days (+/- 3 days). Each vaccine dose will be 0.2 ml.

aldesleukin: Subcutaneous aldesleukin (10 x 10^6 International Units) will be given on day 7 and day 8 after each LMI injection.

Period Title: Overall Study
Started 14
Completed 14
Not Completed 0
Arm/Group Title LMI Vaccination + IL-2
Hide Arm/Group Description

Patients receiving allogeneic large multivalent immunogen breast cancer vaccine and aldesleukin.

allogeneic large multivalent immunogen breast cancer vaccine: Allogeneic large multivalent immunogen breast cancer vaccine (1 x 10^7, 5-μm silica spheres) will be given as an intradermal injection every 28 days (+/- 3 days). Each vaccine dose will be 0.2 ml.

aldesleukin: Subcutaneous aldesleukin (10 x 10^6 International Units) will be given on day 7 and day 8 after each LMI injection.

Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
  71.4%
>=65 years
4
  28.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
14
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Disease Response
Hide Description Percentage of patients achieving complete response, partial response, or disease stabilization as assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) criteria for measurable target lesions and non-measurable non-target lesions assessed by CT, PET-CT or MRI: Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions or persistence of one or more non-target lesions; Disease Stabilization (SD), Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease; Progressive Disease (PD), >=20% increase in the sum of the longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LMI Vaccination + IL-2
Hide Arm/Group Description:

Patients receiving allogeneic large multivalent immunogen breast cancer vaccine and aldesleukin.

allogeneic large multivalent immunogen breast cancer vaccine: Allogeneic large multivalent immunogen breast cancer vaccine (1 x 10^7, 5-μm silica spheres) will be given as an intradermal injection every 28 days (+/- 3 days). Each vaccine dose will be 0.2 ml.

aldesleukin: Subcutaneous aldesleukin (10 x 10^6 International Units) will be given on day 7 and day 8 after each LMI injection.

Overall Number of Participants Analyzed 14
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Secondary Outcome
Title Immune Response
Hide Description Immune responses will be assessed by DTH responses to LMI, IFN-gamma production by CD8+ T cells using the ELISPOT assay, and CD8+ T cell binding to HLA-A2 multimers complexed with breast cancer-derived peptides (multimer analysis).
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ELISpot assays were not run because the HLA-multimer assay did not show any strong responses. As such, only DTH responses to LMI were assessed.
Arm/Group Title LMI Vaccination + IL-2
Hide Arm/Group Description:

Patients receiving allogeneic large multivalent immunogen breast cancer vaccine and aldesleukin.

allogeneic large multivalent immunogen breast cancer vaccine: Allogeneic large multivalent immunogen breast cancer vaccine (1 x 10^7, 5-μm silica spheres) will be given as an intradermal injection every 28 days (+/- 3 days). Each vaccine dose will be 0.2 ml.

aldesleukin: Subcutaneous aldesleukin (10 x 10^6 International Units) will be given on day 7 and day 8 after each LMI injection.

Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Secondary Outcome
Title Progression-free Survival
Hide Description Progression free survival will be measured in months from time of response to time of disease progression as defined by RECIST (appendix II), “at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).”
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
One patient's disease had not progressed by the time the study-specified follow-up period had ended and was not included in the analysis..
Arm/Group Title LMI Vaccination + IL-2
Hide Arm/Group Description:

Patients receiving allogeneic large multivalent immunogen breast cancer vaccine and aldesleukin.

allogeneic large multivalent immunogen breast cancer vaccine: Allogeneic large multivalent immunogen breast cancer vaccine (1 x 10^7, 5-μm silica spheres) will be given as an intradermal injection every 28 days (+/- 3 days). Each vaccine dose will be 0.2 ml.

aldesleukin: Subcutaneous aldesleukin (10 x 10^6 International Units) will be given on day 7 and day 8 after each LMI injection.

Overall Number of Participants Analyzed 13
Median (Inter-Quartile Range)
Unit of Measure: months
4
(3 to 9)
4.Secondary Outcome
Title Overall Survival
Hide Description Number of participants alive at one year
Time Frame 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LMI Vaccination + IL-2
Hide Arm/Group Description:

Patients receiving allogeneic large multivalent immunogen breast cancer vaccine and aldesleukin.

allogeneic large multivalent immunogen breast cancer vaccine: Allogeneic large multivalent immunogen breast cancer vaccine (1 x 10^7, 5-μm silica spheres) will be given as an intradermal injection every 28 days (+/- 3 days). Each vaccine dose will be 0.2 ml.

aldesleukin: Subcutaneous aldesleukin (10 x 10^6 International Units) will be given on day 7 and day 8 after each LMI injection.

Overall Number of Participants Analyzed 14
Measure Type: Count of Participants
Unit of Measure: Participants
11
  78.6%
5.Secondary Outcome
Title Overall Survival
Hide Description Number of participants alive at 2 years
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LMI Vaccination + IL-2
Hide Arm/Group Description:

Patients receiving allogeneic large multivalent immunogen breast cancer vaccine and aldesleukin.

allogeneic large multivalent immunogen breast cancer vaccine: Allogeneic large multivalent immunogen breast cancer vaccine (1 x 10^7, 5-μm silica spheres) will be given as an intradermal injection every 28 days (+/- 3 days). Each vaccine dose will be 0.2 ml.

aldesleukin: Subcutaneous aldesleukin (10 x 10^6 International Units) will be given on day 7 and day 8 after each LMI injection.

Overall Number of Participants Analyzed 14
Measure Type: Count of Participants
Unit of Measure: Participants
8
  57.1%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LMI Vaccination + IL-2
Hide Arm/Group Description

Patients receiving allogeneic large multivalent immunogen breast cancer vaccine and aldesleukin.

allogeneic large multivalent immunogen breast cancer vaccine: Allogeneic large multivalent immunogen breast cancer vaccine (1 x 10^7, 5-μm silica spheres) will be given as an intradermal injection every 28 days (+/- 3 days). Each vaccine dose will be 0.2 ml.

aldesleukin: Subcutaneous aldesleukin (10 x 10^6 International Units) will be given on day 7 and day 8 after each LMI injection.

All-Cause Mortality
LMI Vaccination + IL-2
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LMI Vaccination + IL-2
Affected / at Risk (%)
Total   2/14 (14.29%) 
Nervous system disorders   
Anxiety  1/14 (7.14%) 
Cognitive Disturbance  1/14 (7.14%) 
Vascular disorders   
Thrombus/Embolism  1/14 (7.14%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
LMI Vaccination + IL-2
Affected / at Risk (%)
Total   13/14 (92.86%) 
Blood and lymphatic system disorders   
Low Hemoglobin  1/14 (7.14%) 
Leukopenia  1/14 (7.14%) 
Lymphopenia  1/14 (7.14%) 
Neutropenia  1/14 (7.14%) 
Cardiac disorders   
Heart Palpitations  1/14 (7.14%) 
Eye disorders   
Vision Problems, NOS  1/14 (7.14%) 
Left Visual Hemianopia  1/14 (7.14%) 
Corneal Dystrophy  1/14 (7.14%) 
Macular Degeneration  1/14 (7.14%) 
Eye Pain  1/14 (7.14%) 
Gastrointestinal disorders   
Constipation  3/14 (21.43%) 
Dehydration  1/14 (7.14%) 
Diarrhea  3/14 (21.43%) 
Dry Mouth  1/14 (7.14%) 
Gastritis  1/14 (7.14%) 
Burping  1/14 (7.14%) 
Early Satiety  1/14 (7.14%) 
Heartburn  1/14 (7.14%) 
Hemorrhoids  1/14 (7.14%) 
Stomatitis  2/14 (14.29%) 
Nausea  7/14 (50.00%) 
Abdominal Pain  2/14 (14.29%) 
Liver Pain  1/14 (7.14%) 
Oral Cavity Pain  1/14 (7.14%) 
Taste Alteration  2/14 (14.29%) 
Vomiting  1/14 (7.14%) 
General disorders   
Fever  4/14 (28.57%) 
Fatigue  9/14 (64.29%) 
Flu-Like Syndrome  7/14 (50.00%) 
Flushing  1/14 (7.14%) 
Injection Site Reaction  8/14 (57.14%) 
Chest Pain  3/14 (21.43%) 
Chills  5/14 (35.71%) 
Sweating  1/14 (7.14%) 
Infections and infestations   
Candida Intertrigo  1/14 (7.14%) 
Pneumonia  1/14 (7.14%) 
Oral Thrush  1/14 (7.14%) 
Chronic Sinusitis  2/14 (14.29%) 
Cellulitis  1/14 (7.14%) 
Upper Respiratory Tract Infection  3/14 (21.43%) 
Infection at Surgery Site  1/14 (7.14%) 
Injury, poisoning and procedural complications   
Bruising  2/14 (14.29%) 
Investigations   
Elevated Alkaline Phosphatase  1/14 (7.14%) 
Alanine Aminotransferase Increased  2/14 (14.29%) 
Aspartate aminotransferase increased  1/14 (7.14%) 
Hyperlipidemia  1/14 (7.14%) 
Weight Loss  1/14 (7.14%) 
Metabolism and nutrition disorders   
Anorexia  4/14 (28.57%) 
Hyperglycemia  2/14 (14.29%) 
Hyponatremia  1/14 (7.14%) 
Musculoskeletal and connective tissue disorders   
Arthritis  1/14 (7.14%) 
Fracture  1/14 (7.14%) 
Limited Range of Motion Left shoulder  1/14 (7.14%) 
Back Pain  5/14 (35.71%) 
Bone Pain, NOS  2/14 (14.29%) 
Extremity Pain  4/14 (28.57%) 
Joint Pain  7/14 (50.00%) 
Muscle Pain  3/14 (21.43%) 
Pain on Ambulation  1/14 (7.14%) 
Body Aches  3/14 (21.43%) 
Nervous system disorders   
Cognitive Disturbance  1/14 (7.14%) 
Dizziness  1/14 (7.14%) 
Jittery  1/14 (7.14%) 
Left Foot Drop  1/14 (7.14%) 
Peripheral neuropathy  6/14 (42.86%) 
Headache  1/14 (7.14%) 
Psychiatric disorders   
Confusion  1/14 (7.14%) 
Insomnia  3/14 (21.43%) 
Anxiety  3/14 (21.43%) 
Depression  1/14 (7.14%) 
Euphoria  1/14 (7.14%) 
Respiratory, thoracic and mediastinal disorders   
Allergic Rhinitis  2/14 (14.29%) 
Bronchospasm, Wheezing  1/14 (7.14%) 
Cough  6/14 (42.86%) 
Dyspnea  5/14 (35.71%) 
Vocal Cord Spasm/Dysfunction  1/14 (7.14%) 
Stridor  1/14 (7.14%) 
Hoarseness  2/14 (14.29%) 
Skin and subcutaneous tissue disorders   
Chelitis  1/14 (7.14%) 
Hand Foot Syndrome  3/14 (21.43%) 
Alopecia  7/14 (50.00%) 
Petechiae, Lower Extremity  1/14 (7.14%) 
Erythema, Lower Extremity  1/14 (7.14%) 
Generalized Body Erythema  1/14 (7.14%) 
Vascular disorders   
Lymphedema  1/14 (7.14%) 
Edema: Limb  4/14 (28.57%) 
Hot Flashes  2/14 (14.29%) 
Left Foot Cooler than Right  1/14 (7.14%) 
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: Dr. Douglas Yee
Organization: Masonic Cancer Center, University of Minnesota
Phone: 612-626-8487
EMail: yeexx006@umn.edu
Layout table for additonal information
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00784524     History of Changes
Other Study ID Numbers: 2007LS094
0802M25946 ( Other Identifier: IRB, University of Minnesota )
First Submitted: November 1, 2008
First Posted: November 4, 2008
Results First Submitted: June 21, 2017
Results First Posted: June 6, 2019
Last Update Posted: June 6, 2019