Trial Outcomes & Findings for A Trial of Poly-ICLC in the Management of Recurrent Pediatric Low Grade Gliomas (NCT NCT01188096)
NCT ID: NCT01188096
Last Updated: 2023-06-12
Results Overview
Percentage with no progression of disease by MRI 3D Macdonald criteria. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
6 months
Results posted on
2023-06-12
Participant Flow
Participant milestones
| Measure |
Poly ICLC
Children will receive poly-ICLC 20 mcg/kg twice weekly intramuscular injection (IM). The first 2 doses will be administered in the clinic under supervision.
Poly ICLC: Children will receive poly-ICLC 20 mcg/kg twice weekly IM (using Monday/Wednesday schedule if possible). The first 2 doses will be administered in the clinic under supervision.
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Poly ICLC
Children will receive poly-ICLC 20 mcg/kg twice weekly intramuscular injection (IM). The first 2 doses will be administered in the clinic under supervision.
Poly ICLC: Children will receive poly-ICLC 20 mcg/kg twice weekly IM (using Monday/Wednesday schedule if possible). The first 2 doses will be administered in the clinic under supervision.
|
|---|---|
|
Overall Study
progression of disease
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
A Trial of Poly-ICLC in the Management of Recurrent Pediatric Low Grade Gliomas
Baseline characteristics by cohort
| Measure |
Poly ICLC
n=23 Participants
Children will receive poly-ICLC 20 mcg/kg twice weekly IM (using Monday/Wednesday schedule if possible). The first 2 doses will be administered in the clinic under supervision.
Poly ICLC: Children will receive poly-ICLC 20 mcg/kg twice weekly IM (using Monday/Wednesday schedule if possible). The first 2 doses will be administered in the clinic under supervision.
|
|---|---|
|
Age, Continuous
|
9.17 years
STANDARD_DEVIATION 4.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPercentage with no progression of disease by MRI 3D Macdonald criteria. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Poly ICLC
n=23 Participants
Children will receive poly-ICLC 20 mcg/kg twice weekly IM (using Monday/Wednesday schedule if possible). The first 2 doses will be administered in the clinic under supervision.
Poly ICLC: Children will receive poly-ICLC 20 mcg/kg twice weekly IM (using Monday/Wednesday schedule if possible). The first 2 doses will be administered in the clinic under supervision.
|
|---|---|
|
Progression Free Survival
|
70 percentage of no progression
|
SECONDARY outcome
Timeframe: at 6 months following start treatment with study drugTumor assessments are to be performed per Modified McDonald's criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar criteria for the Modified Mcdonald's Criteria, as accurate and appropriate.
Outcome measures
| Measure |
Poly ICLC
n=23 Participants
Children will receive poly-ICLC 20 mcg/kg twice weekly IM (using Monday/Wednesday schedule if possible). The first 2 doses will be administered in the clinic under supervision.
Poly ICLC: Children will receive poly-ICLC 20 mcg/kg twice weekly IM (using Monday/Wednesday schedule if possible). The first 2 doses will be administered in the clinic under supervision.
|
|---|---|
|
Overall Response Rate
|
74 percentage of response
|
SECONDARY outcome
Timeframe: at 2 years after start of treatment with study drugTumor assessments are to be performed per 3D measurements. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar criteria for the Modified Mcdonald's Criteria, as accurate and appropriate.
Outcome measures
| Measure |
Poly ICLC
n=23 Participants
Children will receive poly-ICLC 20 mcg/kg twice weekly IM (using Monday/Wednesday schedule if possible). The first 2 doses will be administered in the clinic under supervision.
Poly ICLC: Children will receive poly-ICLC 20 mcg/kg twice weekly IM (using Monday/Wednesday schedule if possible). The first 2 doses will be administered in the clinic under supervision.
|
|---|---|
|
Overall Response Rate
|
8.6 percentage of response
|
SECONDARY outcome
Timeframe: month 6, 24 monthsOutcome measures
| Measure |
Poly ICLC
n=23 Participants
Children will receive poly-ICLC 20 mcg/kg twice weekly IM (using Monday/Wednesday schedule if possible). The first 2 doses will be administered in the clinic under supervision.
Poly ICLC: Children will receive poly-ICLC 20 mcg/kg twice weekly IM (using Monday/Wednesday schedule if possible). The first 2 doses will be administered in the clinic under supervision.
|
|---|---|
|
Overall Survival Rate
Month 6
|
100 percentage of survival
|
|
Overall Survival Rate
Year 2
|
100 percentage of survival
|
OTHER_PRE_SPECIFIED outcome
Timeframe: month 6, 24 monthsPopulation: collected during the study as AEs/SAEs and is reflected this way in the record
in pediatric patients with recurrent low grade gliomas
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: month 6, 24 monthsPopulation: Outcome data was not collected and in the course of the study the outcome was not considered primary or secondary.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: month 6, 24 monthsPopulation: Outcome data was not collected; and in the course of the study the outcome was not considered primary or secondary
See if markers can be identified in the serum of patients with recurrent low grade gliomas treated with poly-ICLC.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: month 6, 24 monthsPopulation: Outcome data was not collected; and in the course of the study the outcome was not considered primary or secondary
Look for presence of markers in PBMC and/or cerebrospinal fluid of patients with recurrent low grade gliomas treated with poly-ICLC.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: month 6, 24 monthsPopulation: Outcome data was not collected; and in the course of the study the outcome was not considered primary or secondary
Look for presence of markers in cerebrospinal fluid of patients with recurrent low grade gliomas treated with poly-ICLC.
Outcome measures
Outcome data not reported
Adverse Events
Poly ICLC
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Poly ICLC
n=23 participants at risk
Children will receive poly-ICLC 20 mcg/kg twice weekly IM (using Monday/Wednesday schedule if possible). The first 2 doses will be administered in the clinic under supervision.
Poly ICLC: Children will receive poly-ICLC 20 mcg/kg twice weekly IM (using Monday/Wednesday schedule if possible). The first 2 doses will be administered in the clinic under supervision.
|
|---|---|
|
General disorders
Dehydration
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Gastrointestinal disorders
Diarrhea
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Blood and lymphatic system disorders
Hypoglycemia
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Cardiac disorders
Stroke Intracranial Hemorrhage
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Nervous system disorders
Seizure
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
General disorders
Fever
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Infections and infestations
Kidney Infection
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Renal and urinary disorders
Kidney Stone
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
General disorders
Adjustment of anti-seizure medications
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Nervous system disorders
Hydrocephalus
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
Other adverse events
| Measure |
Poly ICLC
n=23 participants at risk
Children will receive poly-ICLC 20 mcg/kg twice weekly IM (using Monday/Wednesday schedule if possible). The first 2 doses will be administered in the clinic under supervision.
Poly ICLC: Children will receive poly-ICLC 20 mcg/kg twice weekly IM (using Monday/Wednesday schedule if possible). The first 2 doses will be administered in the clinic under supervision.
|
|---|---|
|
Gastrointestinal disorders
Anorexia
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Psychiatric disorders
Anxiety
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Infection
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Gastrointestinal disorders
Abdominal Pain
|
8.7%
2/23 • Number of events 2 • from baseline through year 2
|
|
Blood and lymphatic system disorders
aspartate transferase (AST) Increase
|
26.1%
6/23 • Number of events 10 • from baseline through year 2
|
|
Blood and lymphatic system disorders
Alanine transaminase (ALT) Increase
|
43.5%
10/23 • Number of events 23 • from baseline through year 2
|
|
Blood and lymphatic system disorders
blood urea nitrogen (BUN) Increase
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Blood and lymphatic system disorders
Bilirubin Increase
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Blood and lymphatic system disorders
Anemia
|
17.4%
4/23 • Number of events 10 • from baseline through year 2
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Skin and subcutaneous tissue disorders
Acne (rash)
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Blood and lymphatic system disorders
Alkaline Phosphatase Increase
|
13.0%
3/23 • Number of events 3 • from baseline through year 2
|
|
Blood and lymphatic system disorders
activated partial thromboplastin time (aPTT) Prolonged
|
4.3%
1/23 • Number of events 2 • from baseline through year 2
|
|
Gastrointestinal disorders
Constipation
|
13.0%
3/23 • Number of events 6 • from baseline through year 2
|
|
Blood and lymphatic system disorders
Decreased absolute neutrophil count (ANC)
|
56.5%
13/23 • Number of events 35 • from baseline through year 2
|
|
Blood and lymphatic system disorders
Creatinine Increase
|
8.7%
2/23 • Number of events 2 • from baseline through year 2
|
|
Blood and lymphatic system disorders
Decreased Phosphate
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Eye disorders
Conjunctivitis
|
8.7%
2/23 • Number of events 2 • from baseline through year 2
|
|
Blood and lymphatic system disorders
Decreased Platelet
|
13.0%
3/23 • Number of events 4 • from baseline through year 2
|
|
General disorders
Chills
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Eye disorders
Decreased Visual Acuity Left Eye
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Eye disorders
Decreased Visual Acuity Right Eye
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
General disorders
Fatigue
|
26.1%
6/23 • Number of events 6 • from baseline through year 2
|
|
Nervous system disorders
Genetic Disorder Neurofibromatosis type I (NFI)
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
General disorders
Faint
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Ear and labyrinth disorders
Ear Infection
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
General disorders
Dehydration
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Gastrointestinal disorders
Diarrhea
|
13.0%
3/23 • Number of events 3 • from baseline through year 2
|
|
Blood and lymphatic system disorders
White Blood Cell (WBC) Decrease
|
52.2%
12/23 • Number of events 33 • from baseline through year 2
|
|
Blood and lymphatic system disorders
Elevated aspartate aminotransferase (AST)
|
13.0%
3/23 • Number of events 5 • from baseline through year 2
|
|
Blood and lymphatic system disorders
Elevated blood urea nitrogen (BUN)
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Eye disorders
Dry Eye
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Gastrointestinal disorders
Dysphagia
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Blood and lymphatic system disorders
Lymphocyte Decrease
|
65.2%
15/23 • Number of events 27 • from baseline through year 2
|
|
General disorders
Fever
|
47.8%
11/23 • Number of events 20 • from baseline through year 2
|
|
Nervous system disorders
Headache
|
26.1%
6/23 • Number of events 6 • from baseline through year 2
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
47.8%
11/23 • Number of events 28 • from baseline through year 2
|
|
Musculoskeletal and connective tissue disorders
Hand Muscle Cramp
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Blood and lymphatic system disorders
Hypernatremia
|
13.0%
3/23 • Number of events 3 • from baseline through year 2
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Nervous system disorders
Hydrocephalus
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Blood and lymphatic system disorders
Hypoglycemia
|
13.0%
3/23 • Number of events 3 • from baseline through year 2
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
30.4%
7/23 • Number of events 21 • from baseline through year 2
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
8.7%
2/23 • Number of events 5 • from baseline through year 2
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
47.8%
11/23 • Number of events 23 • from baseline through year 2
|
|
Blood and lymphatic system disorders
Hyponatremia
|
13.0%
3/23 • Number of events 6 • from baseline through year 2
|
|
Blood and lymphatic system disorders
Hypokalemia
|
8.7%
2/23 • Number of events 3 • from baseline through year 2
|
|
General disorders
Insomnia
|
4.3%
1/23 • Number of events 2 • from baseline through year 2
|
|
Nervous system disorders
Motor Neuropathy
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Eye disorders
Nystagmus
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Gastrointestinal disorders
Nausea
|
8.7%
2/23 • Number of events 2 • from baseline through year 2
|
|
Musculoskeletal and connective tissue disorders
Muscle soreness at Injection Site
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.7%
2/23 • Number of events 2 • from baseline through year 2
|
|
Ear and labyrinth disorders
Middle Ear Inflammation
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Musculoskeletal and connective tissue disorders
Injection Site Pain
|
21.7%
5/23 • Number of events 6 • from baseline through year 2
|
|
Renal and urinary disorders
Kidney Infection
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Eye disorders
Pink Eye
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Musculoskeletal and connective tissue disorders
leg pain
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Blood and lymphatic system disorders
Increased Lymphocyte
|
8.7%
2/23 • Number of events 3 • from baseline through year 2
|
|
Eye disorders
Optic Nerve Disorder (Left Esotropia)
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Eye disorders
Optic Nerve Pallor
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Musculoskeletal and connective tissue disorders
low back pain
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
General disorders
Obesity
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Musculoskeletal and connective tissue disorders
left knee pain
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Musculoskeletal and connective tissue disorders
Spasticity
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Cardiac disorders
Tachycardia
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
General disorders
Weight Loss
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Gastrointestinal disorders
Vomiting
|
8.7%
2/23 • Number of events 2 • from baseline through year 2
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Musculoskeletal and connective tissue disorders
Sore arm
|
4.3%
1/23 • Number of events 3 • from baseline through year 2
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
8.7%
2/23 • Number of events 2 • from baseline through year 2
|
|
Nervous system disorders
Seizure
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Infections and infestations
Skin Infection
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Blood and lymphatic system disorders
Platelet Count Increased
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Renal and urinary disorders
Renal Calculi
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Reproductive system and breast disorders
Vaginal Infection
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
4.3%
1/23 • Number of events 1 • from baseline through year 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place