Trial Outcomes & Findings for Vaccine Therapy in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer (NCT NCT00091273)
NCT ID: NCT00091273
Last Updated: 2014-06-20
Results Overview
Participants kept a toxicity diary during the time frame of interest which was reviewed with a study clinician at each visit.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
Days 1,8,15,22,29,36,43,50
Results posted on
2014-06-20
Participant Flow
Participant milestones
| Measure |
Single Arm
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vaccine Therapy in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Single Arm
n=9 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 1,8,15,22,29,36,43,50Population: All treated subjects were assessed.
Participants kept a toxicity diary during the time frame of interest which was reviewed with a study clinician at each visit.
Outcome measures
| Measure |
Single Arm
n=9 Participants
|
|---|---|
|
Safety of the Vaccine
# of Subjects Experiencing a DLT
|
0 participants
|
|
Safety of the Vaccine
# of Subjects Not Experiencing a DLT
|
9 participants
|
PRIMARY outcome
Timeframe: Day 22Population: All treated subjects were assessed.
Outcome measures
| Measure |
Single Arm
n=9 Participants
|
|---|---|
|
Measure of Tumor-antigen-specific Immunity in SIN by ELIspot Assay
Responders
|
8 participants
|
|
Measure of Tumor-antigen-specific Immunity in SIN by ELIspot Assay
Non-responders
|
1 participants
|
SECONDARY outcome
Timeframe: Days 1,8,15,22,29,36,43,50 and Month 3Population: All treated subjects were assessed.
Outcome measures
| Measure |
Single Arm
n=9 Participants
|
|---|---|
|
Measure of Tumor-antigen-specific Immunity in PBMC by Elispot Assay
Responders
|
8 participants
|
|
Measure of Tumor-antigen-specific Immunity in PBMC by Elispot Assay
Non-responders
|
1 participants
|
Adverse Events
Single Arm
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Arm
n=9 participants at risk
|
|---|---|
|
Immune system disorders
Autoimmune Reaction
|
22.2%
2/9 • Days 1-50
|
|
Blood and lymphatic system disorders
Hemoglobin
|
44.4%
4/9 • Days 1-50
|
|
Blood and lymphatic system disorders
Leukocytes
|
11.1%
1/9 • Days 1-50
|
|
Blood and lymphatic system disorders
Lymphopenia
|
22.2%
2/9 • Days 1-50
|
|
General disorders
Fatigue
|
77.8%
7/9 • Days 1-50
|
|
General disorders
Fever
|
11.1%
1/9 • Days 1-50
|
|
General disorders
Rigors/Chills
|
22.2%
2/9 • Days 1-50
|
|
General disorders
Sweating
|
22.2%
2/9 • Days 1-50
|
|
Skin and subcutaneous tissue disorders
Bruising
|
22.2%
2/9 • Days 1-50
|
|
Skin and subcutaneous tissue disorders
Flushing
|
22.2%
2/9 • Days 1-50
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
100.0%
9/9 • Days 1-50
|
|
Gastrointestinal disorders
Anorexia
|
11.1%
1/9 • Days 1-50
|
|
Gastrointestinal disorders
Dehydration
|
11.1%
1/9 • Days 1-50
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
1/9 • Days 1-50
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Oral Cavity
|
11.1%
1/9 • Days 1-50
|
|
Gastrointestinal disorders
Mucositis (Funct/Sympt) - Oral Cavity
|
11.1%
1/9 • Days 1-50
|
|
Gastrointestinal disorders
Nausea
|
44.4%
4/9 • Days 1-50
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
3/9 • Days 1-50
|
|
Hepatobiliary disorders
AST
|
22.2%
2/9 • Days 1-50
|
|
Hepatobiliary disorders
Alkaline Phosphatase
|
11.1%
1/9 • Days 1-50
|
|
Hepatobiliary disorders
Creatinine
|
33.3%
3/9 • Days 1-50
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
11.1%
1/9 • Days 1-50
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
3/9 • Days 1-50
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
3/9 • Days 1-50
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.1%
1/9 • Days 1-50
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.1%
1/9 • Days 1-50
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
1/9 • Days 1-50
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
11.1%
1/9 • Days 1-50
|
|
Nervous system disorders
Dizziness
|
44.4%
4/9 • Days 1-50
|
|
Nervous system disorders
Neuropathy-Sensory
|
11.1%
1/9 • Days 1-50
|
|
General disorders
Pain - Abdomen NOS
|
11.1%
1/9 • Days 1-50
|
|
General disorders
Pain - Head/Headache
|
66.7%
6/9 • Days 1-50
|
|
General disorders
Pain - Joint
|
22.2%
2/9 • Days 1-50
|
|
General disorders
Pain - Muscle
|
33.3%
3/9 • Days 1-50
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • Days 1-50
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place