Trial Outcomes & Findings for Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer (NCT NCT00654030)
NCT ID: NCT00654030
Last Updated: 2018-04-09
Results Overview
The endpoint is immunologic response measured by IFN-ELISPOT. It will be reported as the percent of patients responding to vaccine (\>2 Standard Deviation increase from baseline levels pre-vaccine). The number of individuals responding (\> 2 SD change from baseline vaccine) will provide an approximation of biologic efficacy of the vaccine.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
16 weeks after vaccination
Results posted on
2018-04-09
Participant Flow
Participant milestones
| Measure |
1650-G Arm
Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
1650-G Arm
n=12 Participants
Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 11.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeks after vaccinationThe endpoint is immunologic response measured by IFN-ELISPOT. It will be reported as the percent of patients responding to vaccine (\>2 Standard Deviation increase from baseline levels pre-vaccine). The number of individuals responding (\> 2 SD change from baseline vaccine) will provide an approximation of biologic efficacy of the vaccine.
Outcome measures
| Measure |
1650-G ARM
n=11 Participants
2 immunizations of 1650-G given 4 weeks apart
|
|---|---|
|
Number of Participants Responding to the Vaccine
|
6 Participants
|
Adverse Events
1650-G Arm
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1650-G Arm
n=12 participants at risk
Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
8.3%
1/12 • Number of events 1
|
|
Psychiatric disorders
Suicide Attempt
|
100.0%
1/1 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
1/12 • Number of events 1
|
|
Surgical and medical procedures
Arthroplasty
|
100.0%
1/1 • Number of events 1
|
Other adverse events
| Measure |
1650-G Arm
n=12 participants at risk
Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart
|
|---|---|
|
Gastrointestinal disorders
Abdominal Cramps
|
8.3%
1/12 • Number of events 1
|
|
Blood and lymphatic system disorders
Abnormal absolute nymphs
|
8.3%
1/12 • Number of events 1
|
|
Blood and lymphatic system disorders
Abnormal Albumin
|
16.7%
2/12 • Number of events 3
|
|
Blood and lymphatic system disorders
Abnormal Glucose
|
16.7%
2/12 • Number of events 4
|
|
Blood and lymphatic system disorders
Abnormal hematocrit
|
8.3%
1/12 • Number of events 4
|
|
Blood and lymphatic system disorders
Abnormal hemoglobin
|
8.3%
1/12 • Number of events 1
|
|
Blood and lymphatic system disorders
Abnormal percent lymphs
|
8.3%
1/12 • Number of events 1
|
|
Blood and lymphatic system disorders
Abnormal platelets
|
8.3%
1/12 • Number of events 2
|
|
Blood and lymphatic system disorders
Abnormal RBC
|
8.3%
1/12 • Number of events 3
|
|
Blood and lymphatic system disorders
Abnormal WBC
|
8.3%
1/12 • Number of events 1
|
|
Cardiac disorders
Absent Pedal Pulses
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Achiness
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Achy Joints
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Allergic Rhinitis
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Alopecia
|
8.3%
1/12 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
16.7%
2/12 • Number of events 3
|
|
Blood and lymphatic system disorders
B12 Deficiency
|
8.3%
1/12 • Number of events 1
|
|
Blood and lymphatic system disorders
Bilirubin
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
2/12 • Number of events 2
|
|
Surgical and medical procedures
Cyst removed left foot
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Decreased range of motion (left arm)
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Statis Ulcer
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
41.7%
5/12 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Edema at Injection Site
|
33.3%
4/12 • Number of events 4
|
|
Blood and lymphatic system disorders
Elevated BUN
|
8.3%
1/12 • Number of events 1
|
|
Blood and lymphatic system disorders
Elevated Creatinine
|
8.3%
1/12 • Number of events 1
|
|
Blood and lymphatic system disorders
Elevated Glucose
|
8.3%
1/12 • Number of events 1
|
|
Blood and lymphatic system disorders
Elevated Sodium
|
8.3%
1/12 • Number of events 1
|
|
Cardiac disorders
Enlarged Heart
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Episodic pain- left shoulder
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Faint wheeze - left lung
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Fatigue
|
41.7%
5/12 • Number of events 5
|
|
General disorders
Fever
|
16.7%
2/12 • Number of events 2
|
|
General disorders
Flu-like Symptoms
|
16.7%
2/12 • Number of events 2
|
|
Nervous system disorders
Headaches
|
16.7%
2/12 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for Dyspnea
|
8.3%
1/12 • Number of events 1
|
|
Endocrine disorders
Hot Flashes
|
16.7%
2/12 • Number of events 2
|
|
Cardiac disorders
Hypertension
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation RT Thigh
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Induration - Left Thigh
|
33.3%
4/12 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Induration- Right Thigh
|
33.3%
4/12 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction- Left Thigh
|
41.7%
5/12 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction- Right Thigh
|
33.3%
4/12 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Insect Bite, Right Buttock
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Insomnia
|
16.7%
2/12 • Number of events 3
|
|
General disorders
Intermittent incisional pain, right side of chest
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Itching at site of Insect bite
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Joint Aches
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Left Hip pain
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Left Shoulder Pain
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Leg Cramps
|
8.3%
1/12 • Number of events 1
|
|
Blood and lymphatic system disorders
Low/Abnormal Hemoglobin
|
8.3%
1/12 • Number of events 1
|
|
Blood and lymphatic system disorders
Low/abnormal RBC
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Mucosal Ulceration on Tongue
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis/Stomatitis, Pharynx
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Muscle Weakness, whole body
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal-other-strain
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Nasal Congestion/Stuffiness
|
16.7%
2/12 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Necrosis, right buttock
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Neurological Complaint
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Pain at site of insect bite; right buttock
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Pain at Injection Site
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Pain-Gastrointestinal-abdomen
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Pain in Right Breast
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pain at Injection Site
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Pain in Left Arm
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Post Nasal Drip
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pretibial Edema
|
8.3%
1/12 • Number of events 2
|
|
Infections and infestations
Pulmonary/Upper Respiratory System Infection
|
25.0%
3/12 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Redness at Injection site
|
16.7%
2/12 • Number of events 2
|
|
Nervous system disorders
Restless Leg Syndrome
|
8.3%
1/12 • Number of events 2
|
|
Ear and labyrinth disorders
Ringing in Ears
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sebaceous keratosis right temple
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Shingles
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Sinus Drainage
|
8.3%
1/12 • Number of events 2
|
|
General disorders
Sinus Pressure
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
16.7%
2/12 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Thigh Nodule/Erythema (Right Thigh)
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Thoracotomy Pain- left side
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Thrush
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Urinary Tract Infection
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
3/12 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Study chair (Dr. Edward Hirschowitz) is only party available to disclose, discuss, or publish trial results or information concerning the trial after completion.
- Publication restrictions are in place
Restriction type: OTHER