Trial Outcomes & Findings for Neoadjuvant/Adjuvant Chemotherapy, Vaccine & Adjuvant Radiation Therapy in p53-Overexpressing Stage III Breast Cancer (NCT NCT00082641)

Last Updated: 2023-09-22

Results Overview

This outcome measure looks at the safety of the vaccine by documenting the number of grade 2, 3, or toxicities experienced by participants related to the vaccine.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

24 participants

Primary outcome timeframe

1 week after each vaccine dose.

Results posted on

2023-09-22

Participant Flow

One subject consented to the study voluntarily withdrew consent prior to assignment to an arm, thus only 23 subjects placed in the study arms and are included in the data analysis.

Participant milestones

Participant milestones
Measure	Arm I Patients receive vaccination comprising p53-infected autologous dendritic cells subcutaneously (SC) 1 week after completion of doxorubicin and cyclophosphamide, 1 week after completion of paclitaxel (or after surgery for patients with stage III disease), and at 6 and 12 weeks after completion of radiotherapy (for a total of 4 vaccinations). autologous dendritic cell-adenovirus p53 vaccine: Given subcutaneously on one of two schedules	Arm II Patients receive vaccination comprising p53-infected autologous dendritic cells SC at 6, 8, 10, and 12 weeks after completion of radiotherapy. autologous dendritic cell-adenovirus p53 vaccine: Given subcutaneously on one of two schedules
Overall Study STARTED	11	12
Overall Study COMPLETED	11	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neoadjuvant/Adjuvant Chemotherapy, Vaccine & Adjuvant Radiation Therapy in p53-Overexpressing Stage III Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I n=11 Participants Patients receive vaccination comprising p53-infected autologous dendritic cells subcutaneously (SC) 1 week after completion of doxorubicin and cyclophosphamide, 1 week after completion of paclitaxel (or after surgery for patients with stage III disease), and at 6 and 12 weeks after completion of radiotherapy (for a total of 4 vaccinations). autologous dendritic cell-adenovirus p53 vaccine: Given subcutaneously on one of two schedules	Arm II n=12 Participants Patients receive vaccination comprising p53-infected autologous dendritic cells SC at 6, 8, 10, and 12 weeks after completion of radiotherapy. autologous dendritic cell-adenovirus p53 vaccine: Given subcutaneously on one of two schedules	Total n=23 Participants Total of all reporting groups
Age, Customized Participant >= 19 years of age	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week after each vaccine dose.

This outcome measure looks at the safety of the vaccine by documenting the number of grade 2, 3, or toxicities experienced by participants related to the vaccine.

Outcome measures

Outcome measures
Measure	Arm I n=11 Participants Patients receive vaccination comprising p53-infected autologous dendritic cells subcutaneously (SC) 1 week after completion of doxorubicin and cyclophosphamide, 1 week after completion of paclitaxel (or after surgery for patients with stage III disease), and at 6 and 12 weeks after completion of radiotherapy (for a total of 4 vaccinations). autologous dendritic cell-adenovirus p53 vaccine: Given subcutaneously on one of two schedules	Arm II n=12 Participants Patients receive vaccination comprising p53-infected autologous dendritic cells SC at 6, 8, 10, and 12 weeks after completion of radiotherapy. autologous dendritic cell-adenovirus p53 vaccine: Given subcutaneously on one of two schedules
Number of Participants Who Experienced Toxicity to the Vaccine	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 18 months

Outcome measures

Outcome measures
Measure	Arm I n=11 Participants Patients receive vaccination comprising p53-infected autologous dendritic cells subcutaneously (SC) 1 week after completion of doxorubicin and cyclophosphamide, 1 week after completion of paclitaxel (or after surgery for patients with stage III disease), and at 6 and 12 weeks after completion of radiotherapy (for a total of 4 vaccinations). autologous dendritic cell-adenovirus p53 vaccine: Given subcutaneously on one of two schedules	Arm II n=12 Participants Patients receive vaccination comprising p53-infected autologous dendritic cells SC at 6, 8, 10, and 12 weeks after completion of radiotherapy. autologous dendritic cell-adenovirus p53 vaccine: Given subcutaneously on one of two schedules
Percent of Patients With an Immune Response to p53-infected Autologous Dendritic Cells	100 percentage of patients	53 percentage of patients

PRIMARY outcome

Timeframe: 6 months after last immunization

Population: Due to the low numbers of participants analyze in each arm, 7 participants analyze in the Early vaccine administration 4 participants analyzed in the late vaccine administration the subjects were analyzed together for this outcome.

This outcome measure examined the importance of vaccine timing on antigen-specific relative to the primary cytotoxic therapy on the augmentation of antigen specific immune responses by measuring the duration of immune responses of participants

Outcome measures

Outcome measures
Measure	Arm I n=11 Participants Patients receive vaccination comprising p53-infected autologous dendritic cells subcutaneously (SC) 1 week after completion of doxorubicin and cyclophosphamide, 1 week after completion of paclitaxel (or after surgery for patients with stage III disease), and at 6 and 12 weeks after completion of radiotherapy (for a total of 4 vaccinations). autologous dendritic cell-adenovirus p53 vaccine: Given subcutaneously on one of two schedules	Arm II Patients receive vaccination comprising p53-infected autologous dendritic cells SC at 6, 8, 10, and 12 weeks after completion of radiotherapy. autologous dendritic cell-adenovirus p53 vaccine: Given subcutaneously on one of two schedules
Peak Immune Response as Measured by Number of Spots Per Cells	8.54 spots per 300,000 cells Interval 0.09 to 32.5	—

Adverse Events

Arm I

Serious events: 5 serious events

Other events: 6 other events

Deaths: 0 deaths

Arm II

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I n=11 participants at risk Patients receive vaccination comprising p53-infected autologous dendritic cells subcutaneously (SC) 1 week after completion of doxorubicin and cyclophosphamide, 1 week after completion of paclitaxel (or after surgery for patients with stage III disease), and at 6 and 12 weeks after completion of radiotherapy (for a total of 4 vaccinations). autologous dendritic cell-adenovirus p53 vaccine: Given subcutaneously on one of two schedules	Arm II n=12 participants at risk Patients receive vaccination comprising p53-infected autologous dendritic cells SC at 6, 8, 10, and 12 weeks after completion of radiotherapy. autologous dendritic cell-adenovirus p53 vaccine: Given subcutaneously on one of two schedules
Psychiatric disorders Confusion	9.1% 1/11 • Number of events 1 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	0.00% 0/12 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.
General disorders Fever	9.1% 1/11 • Number of events 1 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	0.00% 0/12 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.
Gastrointestinal disorders Nausea	9.1% 1/11 • Number of events 1 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	0.00% 0/12 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.
Gastrointestinal disorders Vomiting	9.1% 1/11 • Number of events 1 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	0.00% 0/12 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.
Infections and infestations skin infection	9.1% 1/11 • Number of events 1 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	0.00% 0/12 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/11 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	8.3% 1/12 • Number of events 1 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.

Other adverse events

Additional Information

Elizabeth Reed

University of Nebraska

Phone: 402-559-5166

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm I n=11 participants at risk Patients receive vaccination comprising p53-infected autologous dendritic cells subcutaneously (SC) 1 week after completion of doxorubicin and cyclophosphamide, 1 week after completion of paclitaxel (or after surgery for patients with stage III disease), and at 6 and 12 weeks after completion of radiotherapy (for a total of 4 vaccinations). autologous dendritic cell-adenovirus p53 vaccine: Given subcutaneously on one of two schedules	Arm II n=12 participants at risk Patients receive vaccination comprising p53-infected autologous dendritic cells SC at 6, 8, 10, and 12 weeks after completion of radiotherapy. autologous dendritic cell-adenovirus p53 vaccine: Given subcutaneously on one of two schedules
General disorders Pain	9.1% 1/11 • Number of events 1 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	0.00% 0/12 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.
Psychiatric disorders depression	9.1% 1/11 • Number of events 1 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	0.00% 0/12 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.
Gastrointestinal disorders constipation	9.1% 1/11 • Number of events 1 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	0.00% 0/12 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.
Metabolism and nutrition disorders hypocalcemia	0.00% 0/11 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	8.3% 1/12 • Number of events 1 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.
Metabolism and nutrition disorders hypokalemia	0.00% 0/11 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	8.3% 1/12 • Number of events 1 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.
Gastrointestinal disorders vomiting	9.1% 1/11 • Number of events 1 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	0.00% 0/12 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/11 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	8.3% 1/12 • Number of events 1 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.
Blood and lymphatic system disorders anemia	9.1% 1/11 • Number of events 1 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	8.3% 1/12 • Number of events 1 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.
Investigations platelet count decreased	0.00% 0/11 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	8.3% 1/12 • Number of events 1 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.
Investigations white blood cell decreased	18.2% 2/11 • Number of events 2 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	16.7% 2/12 • Number of events 3 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.
Infections and infestations Lung infection	0.00% 0/11 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	8.3% 1/12 • Number of events 1 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.
Investigations neutrophil count decreased	27.3% 3/11 • Number of events 3 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	0.00% 0/12 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.
Metabolism and nutrition disorders hyperglycemia	9.1% 1/11 • Number of events 1 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	0.00% 0/12 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.
Skin and subcutaneous tissue disorders rash maculo-papular	9.1% 1/11 • Number of events 1 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	0.00% 0/12 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.
Gastrointestinal disorders mucositis oral	9.1% 1/11 • Number of events 1 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	0.00% 0/12 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.
Infections and infestations urinary tract infection	0.00% 0/11 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	8.3% 1/12 • Number of events 1 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.
Renal and urinary disorders urinary incontinence	0.00% 0/11 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	8.3% 1/12 • Number of events 1 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.
Nervous system disorders peripheral sensory neuropathy	0.00% 0/11 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	8.3% 1/12 • Number of events 1 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.
Vascular disorders hypertension	0.00% 0/11 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	8.3% 1/12 • Number of events 1 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.
Infections and infestations skin infection	0.00% 0/11 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	8.3% 1/12 • Number of events 1 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.
Nervous system disorders syncope	9.1% 1/11 • Number of events 1 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	0.00% 0/12 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.
Infections and infestations sepsis	0.00% 0/11 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.	8.3% 1/12 • Number of events 1 • Adverse Events will be collected from the time the subject signs the consent form and ending 4 weeks following the final (typically the fourth) vaccine. For Arm A is approximately 5 months. For Arm B is approximately 6 months.