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Poly-ICLC in Treating Patients With Recurrent or Progressive Anaplastic Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00058123
Recruitment Status : Completed
First Posted : April 9, 2003
Results First Posted : August 21, 2018
Last Update Posted : August 21, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Brain and Central Nervous System Tumors
Intervention Drug: poly ICLC
Enrollment 55
Recruitment Details 55 patients enrolled between 7/14/2003 and 12/192005 at Outpatient Clinical Centers
Pre-assignment Details  
Arm/Group Title Poly-ICLC Recurrent Gliomas
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Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday)

Intramuscular injection

poly ICLC

Period Title: Overall Study
Started 55
Completed 45
Not Completed 10
Reason Not Completed
Wrong histology             9
Received >3 prior treatments             1
Arm/Group Title Poly-ICLC Recurrent Gliomas
Hide Arm/Group Description

Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday)

Intramuscular injection

poly ICLC

Overall Number of Baseline Participants 45
Hide Baseline Analysis Population Description
55 enrolled however, 10 were not evaluable for outcomes
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 45 participants
43
(25 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Female
23
  51.1%
Male
22
  48.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   4.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   4.4%
White
40
  88.9%
More than one race
0
   0.0%
Unknown or Not Reported
1
   2.2%
Karnofsky Performance Status Scale   [1] 
Median (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 45 participants
90
(60 to 100)
[1]
Measure Description: Higher score better 100 normal no complaints/disease 90 capable normal activity few symptoms/disease 80 normal activity, some difficulty some symptoms/signs 70 caring for self not capable normal activity/work 60 requiring some help can take care of most personal requirements 50 requires help often requires frequent medical care 40 disabled requires special care/help 30 severely disabled hospital admission indicated but no risk of death 20 very ill urgently requiring admission requires supportive measures/treatment 10 moribund rapidly progressive fatal disease processes 0 death
Histology   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants
Anaplastic Astrocytoma 32
Anaplastic Oligodendroglioma 10
Anaplastic Mixed Oligoastrocytoma 3
[1]
Measure Description: WHO Classification
1.Primary Outcome
Title Proportion of Participants With Objective Response Rate (ORR)
Hide Description

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

Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Poly-ICLC Recurrent Gliomas
Hide Arm/Group Description:

Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday)

Intramuscular injection

Drug Poly-ICLC

poly ICLC

Overall Number of Participants Analyzed 45
Measure Type: Count of Participants
Unit of Measure: Participants
5
  11.1%
2.Primary Outcome
Title Percentage of Participants With Progression Free Survival
Hide Description Participants evaluated from date of study entry to the 6 month scan for progression
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Poly-ICLC Recurrent Gliomas
Hide Arm/Group Description:

Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday)

Intramuscular injection

poly ICLC

Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: percentage of participants
24
3.Secondary Outcome
Title Number if Participants With Grade 3 and 4 Toxicities Associated With Poly-ICLC in Recurrent Gliomas
Hide Description Toxicities defined by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Poly-ICLC Recurrent Gliomas
Hide Arm/Group Description:

Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday)

Intramuscular injection

poly ICLC

Overall Number of Participants Analyzed 45
Measure Type: Count of Participants
Unit of Measure: Participants
Dyspnea
1
   2.2%
Elevated Alanin Aminotransferase
4
   8.9%
Hypoxia
1
   2.2%
Leukopenia
2
   4.4%
Muscle Weakness
1
   2.2%
Elevated Sodium
1
   2.2%
Tremors
2
   4.4%
4.Secondary Outcome
Title Overall Survival
Hide Description based on date of study entry
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Survival time was known for all 45 patients and 13 patients were censored as they were alive at last contact
Arm/Group Title Poly-ICLC Recurrent Gliomas
Hide Arm/Group Description:

Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday)

Intramuscular injection

poly ICLC

Overall Number of Participants Analyzed 45
Median (95% Confidence Interval)
Unit of Measure: weeks
43
(27.4 to 106)
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Poly-ICLC Recurrent Gliomas
Hide Arm/Group Description

Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday)

Intramuscular injection

poly ICLC

All-Cause Mortality
Poly-ICLC Recurrent Gliomas
Affected / at Risk (%)
Total   0/45 (0.00%)    
Hide Serious Adverse Events
Poly-ICLC Recurrent Gliomas
Affected / at Risk (%) # Events
Total   0/45 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Poly-ICLC Recurrent Gliomas
Affected / at Risk (%) # Events
Total   45/45 (100.00%)    
General disorders   
fatigue * 1  28/45 (62.22%)  28
Investigations   
Elevated Alanine Transferase * 1  13/45 (28.89%)  13
Granulocytopenia * 1  7/45 (15.56%)  7
Leukopenia * 1  13/45 (28.89%)  13
Lymphocytopenia * 1  5/45 (11.11%)  5
Skin and subcutaneous tissue disorders   
injection site reaction * 1  3/45 (6.67%)  3
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
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: Susan Chang, MD
Organization: North American Brain Tumor Consortium
Phone: 410-955-8837
EMail: jfisher@jhmi.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00058123    
Other Study ID Numbers: NABTC-0106 CDR0000287012
U01CA062399 ( U.S. NIH Grant/Contract )
NABTC-0106
First Submitted: April 7, 2003
First Posted: April 9, 2003
Results First Submitted: October 14, 2016
Results First Posted: August 21, 2018
Last Update Posted: August 21, 2018