Trial Outcomes & Findings for Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme (NCT NCT00052715)
NCT ID: NCT00052715
Last Updated: 2018-07-18
Results Overview
Overall survival from surgical diagnosis in patients with Newly Diagnosed GBM
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
2 years
Results posted on
2018-07-18
Participant Flow
Patients enrolled from 7/14/2003 through 12/19/2005. Patients recruited from outpatient clinic centers.
Participant milestones
| Measure |
Poly-ICLC
poly-ICLC given at dose of 20mcg/kg 3 times weeekly by intramusclular injection. days of administration were at least 2 days apart. Mon-Wed-fri
Poly-ICLC drug
poly ICLC
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Poly-ICLC
poly-ICLC given at dose of 20mcg/kg 3 times weeekly by intramusclular injection. days of administration were at least 2 days apart. Mon-Wed-fri
Poly-ICLC drug
poly ICLC
|
|---|---|
|
Overall Study
wrong histology
|
1
|
Baseline Characteristics
Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Baseline characteristics by cohort
| Measure |
Poly-ICLC
n=30 Participants
poly-ICLC given at dose of 20mcg/kg 3 times weeekly by intramusclular injection. days of administration were at least 2 days apart. Mon-Wed-fri
Poly-ICLC drug
poly ICLC
|
|---|---|
|
Age, Continuous
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Karnofsky Performance Status Scale
|
90 units on a scale
n=5 Participants
|
|
Histology Glioblastoma
|
30 participants
n=5 Participants
|
|
Extent of Resection
Biopsy
|
2 Participants
n=5 Participants
|
|
Extent of Resection
Subtotal resection
|
17 Participants
n=5 Participants
|
|
Extent of Resection
Gross Total resection
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Four patents were censored for survival at 35, 114, 126, and 166 weeks
Overall survival from surgical diagnosis in patients with Newly Diagnosed GBM
Outcome measures
| Measure |
Poly-ICLC Newly Diagnosed GBM
n=30 Participants
Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy
Intramuscular injection
Drug Poly-ICLC
poly ICLC
|
|---|---|
|
Overall Survival in Pts With Newly Diagnosed GBM
|
65 weeks
Interval 54.8 to 74.2
|
SECONDARY outcome
Timeframe: 6 monthsPatients evaluated from date of diagnosis to the 6 month scan
Outcome measures
| Measure |
Poly-ICLC Newly Diagnosed GBM
n=30 Participants
Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy
Intramuscular injection
Drug Poly-ICLC
poly ICLC
|
|---|---|
|
To Determine 6 Months Progression Free Survival
|
30 percentage of participants
|
SECONDARY outcome
Timeframe: 1 year12-month survival rate calculated from date of diagnosis
Outcome measures
| Measure |
Poly-ICLC Newly Diagnosed GBM
n=30 Participants
Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy
Intramuscular injection
Drug Poly-ICLC
poly ICLC
|
|---|---|
|
Determine the 12-month Survival Rate
|
69 percent of participants
|
SECONDARY outcome
Timeframe: 2 yearsCTCAE 4
Outcome measures
| Measure |
Poly-ICLC Newly Diagnosed GBM
n=30 Participants
Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy
Intramuscular injection
Drug Poly-ICLC
poly ICLC
|
|---|---|
|
to Determine Grade 3 and 4 Toxicities Associated With Poly-ICLC in Newly Diagnosed Patients
Rigor/Chills
|
1 participants
|
|
to Determine Grade 3 and 4 Toxicities Associated With Poly-ICLC in Newly Diagnosed Patients
Fatigue
|
4 participants
|
|
to Determine Grade 3 and 4 Toxicities Associated With Poly-ICLC in Newly Diagnosed Patients
Leukopenia
|
4 participants
|
|
to Determine Grade 3 and 4 Toxicities Associated With Poly-ICLC in Newly Diagnosed Patients
Lymphocytopenia
|
2 participants
|
|
to Determine Grade 3 and 4 Toxicities Associated With Poly-ICLC in Newly Diagnosed Patients
Myalgia
|
1 participants
|
|
to Determine Grade 3 and 4 Toxicities Associated With Poly-ICLC in Newly Diagnosed Patients
Fever without infection
|
1 participants
|
|
to Determine Grade 3 and 4 Toxicities Associated With Poly-ICLC in Newly Diagnosed Patients
Thrombosis
|
2 participants
|
|
to Determine Grade 3 and 4 Toxicities Associated With Poly-ICLC in Newly Diagnosed Patients
Pain
|
1 participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Data was not collected for this outcome measure due to premature discontinuation of study agent in response to what turned out to be pseudo-progression.
Descriptive measure per investigator to describe change in neurological status post-intervention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data was not collected for this outcome measure due to reports of transient enlargement of contrast enhancing disease with subsequent shrinkage during Poly-ICLC treatment and the lack of central radiological review, the protocol defined criteria for radiological response could not be employed because of the risk of inconsistent results
Tumor response to treatment with Poly-ICLC
Outcome measures
Outcome data not reported
Adverse Events
Poly-ICLC
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Poly-ICLC
n=30 participants at risk
poly-ICLC given at dose of 20mcg/kg 3 times weeekly by intramusclular injection. days of administration were at least 2 days apart. Mon-Wed-fri
Poly-ICLC drug
poly ICLC
|
|---|---|
|
General disorders
Fatigue
|
80.0%
24/30 • Number of events 24 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain (Other)
|
36.7%
11/30 • Number of events 11 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
10/30 • Number of events 10 • 2 years
|
|
Blood and lymphatic system disorders
Lymphocytopenia
|
30.0%
9/30 • Number of events 9 • 2 years
|
|
General disorders
Rigors/chills
|
30.0%
9/30 • Number of events 9 • 2 years
|
|
Investigations
Alanine Aminotransferase Increased
|
23.3%
7/30 • Number of events 7 • 2 years
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
23.3%
7/30 • Number of events 7 • 2 years
|
|
Investigations
Alkaline Phosphatase Increased
|
20.0%
6/30 • Number of events 6 • 2 years
|
|
Investigations
Aspartate Aminotransferase Increased
|
20.0%
6/30 • Number of events 6 • 2 years
|
|
Nervous system disorders
Headache
|
20.0%
6/30 • Number of events 6 • 2 years
|
|
Gastrointestinal disorders
nausea
|
16.7%
5/30 • Number of events 5 • 2 years
|
|
Skin and subcutaneous tissue disorders
alopecia
|
13.3%
4/30 • Number of events 4 • 2 years
|
|
Gastrointestinal disorders
Anorexia
|
13.3%
4/30 • Number of events 4 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
13.3%
4/30 • Number of events 4 • 2 years
|
|
General disorders
Fever
|
13.3%
4/30 • Number of events 4 • 2 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
13.3%
4/30 • Number of events 4 • 2 years
|
|
Gastrointestinal disorders
Weight Loss
|
10.0%
3/30 • Number of events 3 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
2/30 • Number of events 2 • 2 years
|
|
Investigations
Blood Bilirubin Increase
|
6.7%
2/30 • Number of events 2 • 2 years
|
|
Skin and subcutaneous tissue disorders
Hyperidrosis
|
6.7%
2/30 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal Other
|
6.7%
2/30 • Number of events 2 • 2 years
|
|
Infections and infestations
Infection Other
|
6.7%
2/30 • Number of events 2 • 2 years
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
6.7%
2/30 • Number of events 2 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
2/30 • Number of events 2 • 2 years
|
|
Nervous system disorders
Seizure
|
6.7%
2/30 • Number of events 2 • 2 years
|
|
Nervous system disorders
Neuropathy Sensory
|
6.7%
2/30 • Number of events 2 • 2 years
|
|
Nervous system disorders
Speech Impairment
|
6.7%
2/30 • Number of events 2 • 2 years
|
Additional Information
Michael Prados, MD
North American Brain Tumor Consortium
Phone: 410-955-8837
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place