Trial Outcomes & Findings for Vaccination-Dendritic Cells With Peptides for Recurrent Malignant Gliomas (NCT NCT00766753)
NCT ID: NCT00766753
Last Updated: 2018-02-07
Results Overview
Number of participants who experienced treatment-related Dose Limiting Toxicities (DLT) at any dose level.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
up to 8 weeks
Results posted on
2018-02-07
Participant Flow
Participant milestones
| Measure |
AlphaDC1 - Dose Level 1(1 X 10 7) + Poly-ICLC
Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid \[poly(I:C)\] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
|
AlphaDC1 - Dose Level 2 (3 x 10 7) + Poly-ICLC
Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid \[poly(I:C)\] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
Received at Least One Vaccine
|
11
|
11
|
|
Overall Study
Completed at Least Four Vaccines
|
10
|
9
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vaccination-Dendritic Cells With Peptides for Recurrent Malignant Gliomas
Baseline characteristics by cohort
| Measure |
AlphaDC1 - Dose Level 1(1 X 10 7) + Poly-ICLC
n=11 Participants
Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid \[poly(I:C)\] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
|
AlphaDC1 - Dose Level 2 (3 x 10 7) + Poly-ICLC
n=11 Participants
Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid \[poly(I:C)\] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
n=5 Participants
|
46 years
n=7 Participants
|
48 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 8 weeksPopulation: Participants at any dose level, through the first booster phase.
Number of participants who experienced treatment-related Dose Limiting Toxicities (DLT) at any dose level.
Outcome measures
| Measure |
AlphaDC1 - Dose Level 1(1 X 10^7) + Poly-ICLC
n=11 Participants
Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid \[poly(I:C)\] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
|
AlphaDC1 - Dose Level 2 (3 x 10^7) + Poly-ICLC
n=11 Participants
Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid \[poly(I:C)\] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
|
|---|---|---|
|
Number of Participants Who Experienced Treatment-related Dose Limiting Toxicities (DLT)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At baseline, 9, 17, 25, and 33 weeks, and every 3 months; up to 23 monthsPopulation: Patients with recurrent malignant glioma treated with novel vaccination with type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for (GAA) epitopes and administration of polyinosinic-polycytidylic acid \[poly(I:C)\] stabilized by lysine and arboxymethylcellulose (poly-ICLC) who received at least one vaccine up to 4 vaccines
Median number of months until disease progression. Tumor size was assessed using magnetic resonance imaging (MRI) scans with contrast enhancement to detect change from baseline.
Outcome measures
| Measure |
AlphaDC1 - Dose Level 1(1 X 10^7) + Poly-ICLC
n=11 Participants
Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid \[poly(I:C)\] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
|
AlphaDC1 - Dose Level 2 (3 x 10^7) + Poly-ICLC
n=11 Participants
Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid \[poly(I:C)\] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
|
|---|---|---|
|
Median Time To Progression
WHO3 AG (anaplastic glioma)
|
5 months
Interval 0.0 to 23.0
|
15 months
Interval 0.0 to 23.0
|
|
Median Time To Progression
WHO4 GBM (glioblastoma multiforme)
|
4 months
Interval 0.0 to 23.0
|
4 months
Interval 0.0 to 23.0
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Patients with recurrent malignant glioma treated with novel vaccination with type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for (GAA) epitopes and administration of polyinosinic-polycytidylic acid \[poly(I:C)\] stabilized by lysine and arboxymethylcellulose (poly-ICLC) who received at least one vaccine up to 4 vaccines
Number of patients with progression-free status lasting at least 12 months
Outcome measures
| Measure |
AlphaDC1 - Dose Level 1(1 X 10^7) + Poly-ICLC
n=11 Participants
Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid \[poly(I:C)\] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
|
AlphaDC1 - Dose Level 2 (3 x 10^7) + Poly-ICLC
n=11 Participants
Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid \[poly(I:C)\] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
|
|---|---|---|
|
12-month- Progression Free Survival (PFS)
AA (anaplastic astrocytoma)
|
2 participants
|
1 participants
|
|
12-month- Progression Free Survival (PFS)
AO (anaplastic oligodendroglioma)
|
1 participants
|
1 participants
|
|
12-month- Progression Free Survival (PFS)
AOA (anaplastic oligoastrocytoma)
|
0 participants
|
1 participants
|
|
12-month- Progression Free Survival (PFS)
GBM (glioblastoma multiforme)
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Up to 102 monthsPopulation: Patients with recurrent malignant glioma treated with novel vaccination with type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for (GAA) epitopes and administration of polyinosinic-polycytidylic acid \[poly(I:C)\] stabilized by lysine and arboxymethylcellulose (poly-ICLC) who received at least one vaccine up to 4 vaccines
Time interval from start of treatment until date of death.
Outcome measures
| Measure |
AlphaDC1 - Dose Level 1(1 X 10^7) + Poly-ICLC
n=11 Participants
Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid \[poly(I:C)\] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
|
AlphaDC1 - Dose Level 2 (3 x 10^7) + Poly-ICLC
n=11 Participants
Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid \[poly(I:C)\] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
|
|---|---|---|
|
Overall Survival (OS)
|
32.88 months
Interval 13.58 to 36.59
|
13.28 months
Interval 5.59 to 36.79
|
Adverse Events
Alpha DC1 Vaccine + Poly-ICLC
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alpha DC1 Vaccine + Poly-ICLC
n=22 participants at risk
Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for (GAA) epitopes and administration of polyinosinic-polycytidylic acid \[poly(I:C)\] stabilized by lysine and arboxymethylcellulose (poly-ICLC) who received at least one vaccine, up to 4 vaccines
|
|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
9.1%
2/22
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
4.5%
1/22
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
4.5%
1/22
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
4.5%
1/22
|
Other adverse events
| Measure |
Alpha DC1 Vaccine + Poly-ICLC
n=22 participants at risk
Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for (GAA) epitopes and administration of polyinosinic-polycytidylic acid \[poly(I:C)\] stabilized by lysine and arboxymethylcellulose (poly-ICLC) who received at least one vaccine, up to 4 vaccines
|
|---|---|
|
Ear and labyrinth disorders
Auditory/Ear - Other (Specify, __)
|
9.1%
2/22
|
|
Blood and lymphatic system disorders
Lymphopenia
|
9.1%
2/22
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
18.2%
4/22
|
|
Cardiac disorders
Hypertension
|
9.1%
2/22
|
|
General disorders
Weight gain
|
9.1%
2/22
|
|
General disorders
Insomnia
|
18.2%
4/22
|
|
General disorders
Rigors/chills
|
22.7%
5/22
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
31.8%
7/22
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
63.6%
14/22
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
|
9.1%
2/22
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
13.6%
3/22
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
13.6%
3/22
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __)
|
18.2%
4/22
|
|
Skin and subcutaneous tissue disorders
Injection site reaction/extravasation changes
|
59.1%
13/22
|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
2/22
|
|
Gastrointestinal disorders
Nausea
|
40.9%
9/22
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Sinus
|
13.6%
3/22
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
9.1%
2/22
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
9.1%
2/22
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy), Left-sided
|
9.1%
2/22
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, __)
|
13.6%
3/22
|
|
Nervous system disorders
Memory impairment
|
9.1%
2/22
|
|
Nervous system disorders
Neurology - Other (Specify, __)
|
9.1%
2/22
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
13.6%
3/22
|
|
Nervous system disorders
Confusion
|
18.2%
4/22
|
|
Nervous system disorders
Neuropathy: motor
|
18.2%
4/22
|
|
Nervous system disorders
Seizure
|
18.2%
4/22
|
|
Nervous system disorders
Dizziness
|
22.7%
5/22
|
|
Nervous system disorders
Neuropathy: sensory
|
22.7%
5/22
|
|
General disorders
Pain, Throat/pharynx/larynx
|
13.6%
3/22
|
|
General disorders
Pain, Muscle
|
18.2%
4/22
|
|
General disorders
Pain - Other (Specify, __)
|
31.8%
7/22
|
|
General disorders
Pain, Extremity-limb
|
40.9%
9/22
|
|
General disorders
Pain, Head/headache
|
59.1%
13/22
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
2/22
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __)
|
9.1%
2/22
|
|
General disorders
Flu-like syndrome
|
18.2%
4/22
|
Additional Information
Frank Lieberman
University of Pittsburgh Cancer Institute
Phone: (412) 648-6507
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place