Trial Outcomes & Findings for Phase II Trial of Peginterferon Alpha-2b and Thalidomide in Adults With Recurrent Gliomas (NCT NCT00047879)
NCT ID: NCT00047879
Last Updated: 2011-10-26
Results Overview
Progression free survival is defined as the percent of patients that are progression free and alive 6 months after initiating therapy. Progression of disease by \> 50% increase in the size of the tumor compared to baseline after the first cycle only, and then \>25% increase in the size of the tumor for all subsequent cycles.
COMPLETED
PHASE2
7 participants
6 months
2011-10-26
Participant Flow
We planned to accrue 32 patients to the GBM stratum and 32 patients to the AG stratum. The accrual ceiling was 64 patients on this trial. We anticipated accruing these patients within one year of opening this study.
Participant milestones
| Measure |
Glioblastoma Multiforme Stratum
Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
|
Anaplastic Glioma Stratum
Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Glioblastoma Multiforme Stratum
Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
|
Anaplastic Glioma Stratum
Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
|
|---|---|---|
|
Overall Study
Progressive disease
|
4
|
3
|
Baseline Characteristics
Phase II Trial of Peginterferon Alpha-2b and Thalidomide in Adults With Recurrent Gliomas
Baseline characteristics by cohort
| Measure |
Glioblastoma Multiforme Stratum
n=4 Participants
Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
|
Anaplastic Glioma Stratum
n=3 Participants
Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age Continuous
|
55.5 years
STANDARD_DEVIATION 10.85 • n=5 Participants
|
53.67 years
STANDARD_DEVIATION 11.93 • n=7 Participants
|
54.71 years
STANDARD_DEVIATION 10.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The primary objective was not met. Only registered 7 out of 64 participants and they all came off the study for progressive disease around 3-4 months after starting the study. None of the participants were evaluated for progression-free survival at 6 months because the study was stopped at 4 months due to progressive disease.
Progression free survival is defined as the percent of patients that are progression free and alive 6 months after initiating therapy. Progression of disease by \> 50% increase in the size of the tumor compared to baseline after the first cycle only, and then \>25% increase in the size of the tumor for all subsequent cycles.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Registered 7 out of 64 participants and they came off study for progressive disease around 3-4 months after starting the study.
Response is defined per RECIST criteria. Measurable disease is defined as bidimensionally measurable lesions with clearly defined margins by CT or MRI scan. Evaluable disease is defined as unidimensionally measurable lesions, masses with margins not clearly defined, or lesions with a multiple cystic component. Complete response (CR) is complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to 50% decrease under baseline in the sum of products or perpendicular diameters of all measurable lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthsHere are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Glioblastoma Multiforme Stratum
n=4 Participants
Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
|
Anaplastic Glioma Stratum
n=3 Participants
Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
|
|---|---|---|
|
The Number of Participants With Adverse Events
|
4 Participants
|
2 Participants
|
Adverse Events
Glioblastoma Multiforme Stratum
Anaplastic Glioma Stratum
Serious adverse events
| Measure |
Glioblastoma Multiforme Stratum
n=4 participants at risk
Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
|
Anaplastic Glioma Stratum
n=3 participants at risk
Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • 4 months
|
33.3%
1/3 • Number of events 1 • 4 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • 4 months
|
33.3%
1/3 • Number of events 1 • 4 months
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • 4 months
|
33.3%
1/3 • Number of events 1 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/4 • 4 months
|
33.3%
1/3 • Number of events 1 • 4 months
|
|
Investigations
Thrombocytopenia
|
0.00%
0/4 • 4 months
|
33.3%
1/3 • Number of events 1 • 4 months
|
|
Metabolism and nutrition disorders
Metabolic, hyperglycemia
|
25.0%
1/4 • Number of events 1 • 4 months
|
0.00%
0/3 • 4 months
|
|
Nervous system disorders
Seizure
|
25.0%
1/4 • Number of events 1 • 4 months
|
0.00%
0/3 • 4 months
|
|
Investigations
Elevated AST
|
25.0%
1/4 • Number of events 1 • 4 months
|
0.00%
0/3 • 4 months
|
Other adverse events
| Measure |
Glioblastoma Multiforme Stratum
n=4 participants at risk
Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
|
Anaplastic Glioma Stratum
n=3 participants at risk
Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
|
|---|---|---|
|
General disorders
edema: limb right upper extremity
|
0.00%
0/4 • 4 months
|
33.3%
1/3 • Number of events 1 • 4 months
|
|
Investigations
Thrombocytopenia
|
0.00%
0/4 • 4 months
|
33.3%
1/3 • Number of events 1 • 4 months
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 3 • 4 months
|
0.00%
0/3 • 4 months
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • 4 months
|
0.00%
0/3 • 4 months
|
|
Infections and infestations
Infection
|
25.0%
1/4 • Number of events 1 • 4 months
|
0.00%
0/3 • 4 months
|
|
Investigations
Metabolic, ALT elevated
|
25.0%
1/4 • Number of events 1 • 4 months
|
0.00%
0/3 • 4 months
|
|
Nervous system disorders
Pain, skin
|
25.0%
1/4 • Number of events 1 • 4 months
|
0.00%
0/3 • 4 months
|
|
Psychiatric disorders
Mood alteration
|
25.0%
1/4 • Number of events 1 • 4 months
|
0.00%
0/3 • 4 months
|
|
Psychiatric disorders
Confusion
|
25.0%
1/4 • Number of events 1 • 4 months
|
0.00%
0/3 • 4 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
1/4 • Number of events 1 • 4 months
|
0.00%
0/3 • 4 months
|
|
General disorders
Fever
|
25.0%
1/4 • Number of events 1 • 4 months
|
0.00%
0/3 • 4 months
|
|
Investigations
AST
|
25.0%
1/4 • Number of events 1 • 4 months
|
0.00%
0/3 • 4 months
|
|
Investigations
Glucose
|
25.0%
1/4 • Number of events 1 • 4 months
|
0.00%
0/3 • 4 months
|
|
Investigations
Elevated AST
|
25.0%
1/4 • Number of events 1 • 4 months
|
0.00%
0/3 • 4 months
|
|
Investigations
Elevated bilirubin
|
25.0%
1/4 • Number of events 1 • 4 months
|
0.00%
0/3 • 4 months
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • 4 months
|
0.00%
0/3 • 4 months
|
|
Nervous system disorders
Neurology, somnolence
|
25.0%
1/4 • Number of events 1 • 4 months
|
0.00%
0/3 • 4 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • Number of events 1 • 4 months
|
0.00%
0/3 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, other leg/foot cramp
|
25.0%
1/4 • Number of events 1 • 4 months
|
0.00%
0/3 • 4 months
|
Additional Information
Howard A. Fine, M.D.
National Cancer Institute, National Institutes of Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place