Trial Outcomes & Findings for Phase II Study of Allo LMI Vaccine With IL-2 for Stable Metastatic Breast Ca (NCT NCT00784524)
NCT ID: NCT00784524
Last Updated: 2019-06-06
Results Overview
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.
TERMINATED
PHASE2
14 participants
Up to 2 years
2019-06-06
Participant Flow
Participant milestones
| Measure |
LMI Vaccination + IL-2
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 Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study of Allo LMI Vaccine With IL-2 for Stable Metastatic Breast Ca
Baseline characteristics by cohort
| Measure |
LMI Vaccination + IL-2
n=14 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPercentage 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.
Outcome measures
| Measure |
LMI Vaccination + IL-2
n=14 Participants
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.
|
|---|---|
|
Disease Response
|
0 Participants
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: 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.
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).
Outcome measures
| Measure |
LMI Vaccination + IL-2
n=13 Participants
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.
|
|---|---|
|
Immune Response
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: 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..
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)."
Outcome measures
| Measure |
LMI Vaccination + IL-2
n=13 Participants
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.
|
|---|---|
|
Progression-free Survival
|
4 months
Interval 3.0 to 9.0
|
SECONDARY outcome
Timeframe: 1 YearNumber of participants alive at one year
Outcome measures
| Measure |
LMI Vaccination + IL-2
n=14 Participants
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 Survival
|
11 Participants
|
SECONDARY outcome
Timeframe: 2 yearsNumber of participants alive at 2 years
Outcome measures
| Measure |
LMI Vaccination + IL-2
n=14 Participants
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 Survival
|
8 Participants
|
Adverse Events
LMI Vaccination + IL-2
Serious adverse events
| Measure |
LMI Vaccination + IL-2
n=14 participants at risk
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.
|
|---|---|
|
Nervous system disorders
Anxiety
|
7.1%
1/14
|
|
Nervous system disorders
Cognitive Disturbance
|
7.1%
1/14
|
|
Vascular disorders
Thrombus/Embolism
|
7.1%
1/14
|
Other adverse events
| Measure |
LMI Vaccination + IL-2
n=14 participants at risk
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.
|
|---|---|
|
Investigations
Elevated Alkaline Phosphatase
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
14.3%
2/14
|
|
Investigations
Alanine Aminotransferase Increased
|
14.3%
2/14
|
|
Metabolism and nutrition disorders
Anorexia
|
28.6%
4/14
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.1%
1/14
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, Wheezing
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Bruising
|
14.3%
2/14
|
|
Skin and subcutaneous tissue disorders
Chelitis
|
7.1%
1/14
|
|
Nervous system disorders
Cognitive Disturbance
|
7.1%
1/14
|
|
Psychiatric disorders
Confusion
|
7.1%
1/14
|
|
Gastrointestinal disorders
Constipation
|
21.4%
3/14
|
|
General disorders
Fever
|
28.6%
4/14
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
42.9%
6/14
|
|
Gastrointestinal disorders
Dehydration
|
7.1%
1/14
|
|
Vascular disorders
Lymphedema
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Hand Foot Syndrome
|
21.4%
3/14
|
|
Infections and infestations
Candida Intertrigo
|
7.1%
1/14
|
|
Gastrointestinal disorders
Diarrhea
|
21.4%
3/14
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14
|
|
Gastrointestinal disorders
Dry Mouth
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
35.7%
5/14
|
|
Vascular disorders
Edema: Limb
|
28.6%
4/14
|
|
Nervous system disorders
Jittery
|
7.1%
1/14
|
|
General disorders
Fatigue
|
64.3%
9/14
|
|
General disorders
Flu-Like Syndrome
|
50.0%
7/14
|
|
General disorders
Flushing
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
7.1%
1/14
|
|
Gastrointestinal disorders
Gastritis
|
7.1%
1/14
|
|
Gastrointestinal disorders
Burping
|
7.1%
1/14
|
|
Gastrointestinal disorders
Early Satiety
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
2/14
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
7/14
|
|
Gastrointestinal disorders
Heartburn
|
7.1%
1/14
|
|
Blood and lymphatic system disorders
Low Hemoglobin
|
7.1%
1/14
|
|
Gastrointestinal disorders
Hemorrhoids
|
7.1%
1/14
|
|
Vascular disorders
Hot Flashes
|
14.3%
2/14
|
|
Infections and infestations
Pneumonia
|
7.1%
1/14
|
|
Infections and infestations
Oral Thrush
|
7.1%
1/14
|
|
Infections and infestations
Chronic Sinusitis
|
14.3%
2/14
|
|
Infections and infestations
Cellulitis
|
7.1%
1/14
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
21.4%
3/14
|
|
Infections and infestations
Infection at Surgery Site
|
7.1%
1/14
|
|
General disorders
Injection Site Reaction
|
57.1%
8/14
|
|
Psychiatric disorders
Insomnia
|
21.4%
3/14
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.1%
1/14
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.1%
1/14
|
|
Investigations
Hyperlipidemia
|
7.1%
1/14
|
|
Psychiatric disorders
Anxiety
|
21.4%
3/14
|
|
Psychiatric disorders
Depression
|
7.1%
1/14
|
|
Gastrointestinal disorders
Stomatitis
|
14.3%
2/14
|
|
Nervous system disorders
Left Foot Drop
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Limited Range of Motion Left shoulder
|
7.1%
1/14
|
|
Gastrointestinal disorders
Nausea
|
50.0%
7/14
|
|
Vascular disorders
Left Foot Cooler than Right
|
7.1%
1/14
|
|
Psychiatric disorders
Euphoria
|
7.1%
1/14
|
|
Nervous system disorders
Peripheral neuropathy
|
42.9%
6/14
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Vocal Cord Spasm/Dysfunction
|
7.1%
1/14
|
|
Eye disorders
Vision Problems, NOS
|
7.1%
1/14
|
|
Eye disorders
Left Visual Hemianopia
|
7.1%
1/14
|
|
Eye disorders
Corneal Dystrophy
|
7.1%
1/14
|
|
Eye disorders
Macular Degeneration
|
7.1%
1/14
|
|
Gastrointestinal disorders
Abdominal Pain
|
14.3%
2/14
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
35.7%
5/14
|
|
Musculoskeletal and connective tissue disorders
Bone Pain, NOS
|
14.3%
2/14
|
|
General disorders
Chest Pain
|
21.4%
3/14
|
|
Musculoskeletal and connective tissue disorders
Extremity Pain
|
28.6%
4/14
|
|
Eye disorders
Eye Pain
|
7.1%
1/14
|
|
Nervous system disorders
Headache
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
50.0%
7/14
|
|
Gastrointestinal disorders
Liver Pain
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
21.4%
3/14
|
|
Gastrointestinal disorders
Oral Cavity Pain
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Pain on Ambulation
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Body Aches
|
21.4%
3/14
|
|
Cardiac disorders
Heart Palpitations
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Petechiae, Lower Extremity
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Erythema, Lower Extremity
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Generalized Body Erythema
|
7.1%
1/14
|
|
General disorders
Chills
|
35.7%
5/14
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.1%
1/14
|
|
General disorders
Sweating
|
7.1%
1/14
|
|
Gastrointestinal disorders
Taste Alteration
|
14.3%
2/14
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
14.3%
2/14
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14
|
|
Investigations
Weight Loss
|
7.1%
1/14
|
Additional Information
Dr. Douglas Yee
Masonic Cancer Center, University of Minnesota
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place