Trial Outcomes & Findings for Poly-ICLC in Treating Patients With Recurrent or Progressive Anaplastic Glioma (NCT NCT00058123)
NCT ID: NCT00058123
Last Updated: 2018-08-21
Results Overview
Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined. Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids. Partial Response (PR): \>/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone. Stable/No Response: Does not qualify for CR, PR, or progression. Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). ORR = CR + PR
COMPLETED
PHASE2
55 participants
2 years
2018-08-21
Participant Flow
55 patients enrolled between 7/14/2003 and 12/192005 at Outpatient Clinical Centers
Participant milestones
| Measure |
Poly-ICLC Recurrent Gliomas
Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday)
Intramuscular injection
poly ICLC
|
|---|---|
|
Overall Study
STARTED
|
55
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Poly-ICLC Recurrent Gliomas
Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday)
Intramuscular injection
poly ICLC
|
|---|---|
|
Overall Study
Wrong histology
|
9
|
|
Overall Study
Received >3 prior treatments
|
1
|
Baseline Characteristics
Poly-ICLC in Treating Patients With Recurrent or Progressive Anaplastic Glioma
Baseline characteristics by cohort
| Measure |
Poly-ICLC Recurrent Gliomas
n=45 Participants
Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday)
Intramuscular injection
poly ICLC
|
|---|---|
|
Age, Customized
|
43 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Karnofsky Performance Status Scale
|
90 units on a scale
n=99 Participants
|
|
Histology
Anaplastic Astrocytoma
|
32 participants
n=99 Participants
|
|
Histology
Anaplastic Oligodendroglioma
|
10 participants
n=99 Participants
|
|
Histology
Anaplastic Mixed Oligoastrocytoma
|
3 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 yearsMeasurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined. Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids. Partial Response (PR): \>/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone. Stable/No Response: Does not qualify for CR, PR, or progression. Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). ORR = CR + PR
Outcome measures
| Measure |
Poly-ICLC Recurrent Gliomas
n=45 Participants
Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday)
Intramuscular injection
Drug Poly-ICLC
poly ICLC
|
|---|---|
|
Proportion of Participants With Objective Response Rate (ORR)
|
5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsParticipants evaluated from date of study entry to the 6 month scan for progression
Outcome measures
| Measure |
Poly-ICLC Recurrent Gliomas
n=45 Participants
Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday)
Intramuscular injection
Drug Poly-ICLC
poly ICLC
|
|---|---|
|
Percentage of Participants With Progression Free Survival
|
24 percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsToxicities defined by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Outcome measures
| Measure |
Poly-ICLC Recurrent Gliomas
n=45 Participants
Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday)
Intramuscular injection
Drug Poly-ICLC
poly ICLC
|
|---|---|
|
Number if Participants With Grade 3 and 4 Toxicities Associated With Poly-ICLC in Recurrent Gliomas
Elevated Sodium
|
1 Participants
|
|
Number if Participants With Grade 3 and 4 Toxicities Associated With Poly-ICLC in Recurrent Gliomas
Tremors
|
2 Participants
|
|
Number if Participants With Grade 3 and 4 Toxicities Associated With Poly-ICLC in Recurrent Gliomas
Dyspnea
|
1 Participants
|
|
Number if Participants With Grade 3 and 4 Toxicities Associated With Poly-ICLC in Recurrent Gliomas
Elevated Alanin Aminotransferase
|
4 Participants
|
|
Number if Participants With Grade 3 and 4 Toxicities Associated With Poly-ICLC in Recurrent Gliomas
Hypoxia
|
1 Participants
|
|
Number if Participants With Grade 3 and 4 Toxicities Associated With Poly-ICLC in Recurrent Gliomas
Leukopenia
|
2 Participants
|
|
Number if Participants With Grade 3 and 4 Toxicities Associated With Poly-ICLC in Recurrent Gliomas
Muscle Weakness
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Survival time was known for all 45 patients and 13 patients were censored as they were alive at last contact
based on date of study entry
Outcome measures
| Measure |
Poly-ICLC Recurrent Gliomas
n=45 Participants
Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday)
Intramuscular injection
Drug Poly-ICLC
poly ICLC
|
|---|---|
|
Overall Survival
|
43 weeks
Interval 27.4 to 106.0
|
Adverse Events
Poly-ICLC Recurrent Gliomas
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Poly-ICLC Recurrent Gliomas
n=45 participants at risk
Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday)
Intramuscular injection
poly ICLC
|
|---|---|
|
General disorders
fatigue
|
62.2%
28/45 • Number of events 28 • 2 years
|
|
Skin and subcutaneous tissue disorders
injection site reaction
|
6.7%
3/45 • Number of events 3 • 2 years
|
|
Investigations
Elevated Alanine Transferase
|
28.9%
13/45 • Number of events 13 • 2 years
|
|
Investigations
Granulocytopenia
|
15.6%
7/45 • Number of events 7 • 2 years
|
|
Investigations
Leukopenia
|
28.9%
13/45 • Number of events 13 • 2 years
|
|
Investigations
Lymphocytopenia
|
11.1%
5/45 • Number of events 5 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place