Trial Outcomes & Findings for Vaccine Plus Booster Shots in Men With Prostate Cancer Undergoing Treatment With Radical Prostatectomy (NCT NCT02153918)

Last Updated: 2018-10-12

Results Overview

Immunologic CD4 and CD8 cell infiltrate response of a neoadjuvant prime/boost vaccine strategy in prostatectomy specimens. Prostate biopsy specimens are collected and stained for CD4 and CD8 cells. Quantification is reported as the number of stained cells per micron squared of surface area. Change will be noted by utilizing computer automated staining analysis. Density of cell infiltrate will be calculated and the pre and post vaccine values will be compared to determine response to vaccine.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

Baseline (pre vaccination) and approximately week 10

Results posted on

2018-10-12

Participant Flow

Participant milestones

Participant milestones
Measure	Vaccine Plus Booster Shots PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC PROSTVAC-V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.
Overall Study STARTED	27
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Vaccine Plus Booster Shots PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC PROSTVAC-V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.
Overall Study Refused further treatment	1

Baseline Characteristics

One subject did not have baseline MRI performed.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vaccine Plus Booster Shots n=27 Participants PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC PROSTVAC-V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.
Age, Categorical <=18 years	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=27 Participants
Age, Categorical >=65 years	13 Participants n=27 Participants
Age, Continuous	64.24 years STANDARD_DEVIATION 6.62 • n=27 Participants
Sex: Female, Male Female	0 Participants n=27 Participants
Sex: Female, Male Male	27 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=27 Participants
Race/Ethnicity, Customized White	23 Participants n=27 Participants
Race/Ethnicity, Customized Mexican, Puerto Rican, Central or So. Amer. or Oth	2 Participants n=27 Participants
Race/Ethnicity, Customized Not meeting definition for Hispanic or Latino	25 Participants n=27 Participants
Race/Ethnicity, Customized Multi-racial	1 Participants n=27 Participants
Region of Enrollment United States	27 participants n=27 Participants
Baseline Prostatic Specific Antigen (PSA)	9.66 ng/ml STANDARD_DEVIATION 10.45 • n=27 Participants
Magnetic Resonance Imaging (MRI) Prostate Volume at Baseline	45.70 cc STANDARD_DEVIATION 17.24 • n=26 Participants • One subject did not have baseline MRI performed.
Number of Lesions on MRI at Baseline	2.04 lesions STANDARD_DEVIATION 1.21 • n=26 Participants • One patient did not have baseline MRI performed.
Largest Lesion Size at Baseline	1.55 cm STANDARD_DEVIATION 0.92 • n=26 Participants • One patient did not have baseline MRI performed.
Number of Participants with Gleason Score 6-10 at Baseline Gleason score 6-7 (3+4)	11 Participants n=27 Participants
Number of Participants with Gleason Score 6-10 at Baseline Gleason score 7 (4+3)	8 Participants n=27 Participants
Number of Participants with Gleason Score 6-10 at Baseline Gleason score 8-10	8 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline (pre vaccination) and approximately week 10

Population: Only 26 participants had available tissue for analysis.

Outcome measures

Outcome measures
Measure	Vaccine Plus Booster Shots n=26 Participants PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC PROSTVAC-V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.
Changes From Baseline to After Surgery of Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Infiltrates Median CD4 at baseline	132.2 Cell/mm(2) Interval 5.856 to 735.2
Changes From Baseline to After Surgery of Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Infiltrates Median CD4 at week 10	153.7 Cell/mm(2) Interval 33.71 to 1368.0
Changes From Baseline to After Surgery of Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Infiltrates Median CD8 at baseline	105.1 Cell/mm(2) Interval 28.0 to 637.0
Changes From Baseline to After Surgery of Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Infiltrates Median CD8 at week 10	140.5 Cell/mm(2) Interval 9.45 to 514.0

SECONDARY outcome

Timeframe: Baseline (pre vaccination) and week 10

Population: 25/27 pts analyzed because 2x10(6) viable cells are required to setup the stimulation assay for each antigen at each time point and one patient had no viable cells after thawing blood. One patient could not be analyzed due to an experimental error which was a clog in the flow cytometry that occurred during acquisition for the final assay readout.

Change in peripheral prostatic specific antigen (PSA)-specific T cells will be assessed by the enzyme-linked immunospot (ELISPOT) assay. A change of \>250 cluster of differentiation 4 (CD4) or cluster of differentiation 8 (CD8) cells producing cytokine or positive for cluster of differentiation 107a (CD107a) in response to PSA post vaccination relative to baseline will be considered evidence of an immunologic response to the vaccine. The number of subjects developing positive PSA-Specific T cell responses with vaccination will be reported.

Outcome measures

Outcome measures
Measure	Vaccine Plus Booster Shots n=25 Participants PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC PROSTVAC-V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.
Count of Participants With Change in Peripheral Prostatic Specific Antigen (PSA)-Specific T Cell Responses CD4 CD107a	4 Participants
Count of Participants With Change in Peripheral Prostatic Specific Antigen (PSA)-Specific T Cell Responses CD4 interferon gamma (IFNq)	2 Participants
Count of Participants With Change in Peripheral Prostatic Specific Antigen (PSA)-Specific T Cell Responses CD4 interleukin-2 (IL2)	1 Participants
Count of Participants With Change in Peripheral Prostatic Specific Antigen (PSA)-Specific T Cell Responses CD4 tumor necrosis factor (TNF)	0 Participants
Count of Participants With Change in Peripheral Prostatic Specific Antigen (PSA)-Specific T Cell Responses CD8 CD107a	0 Participants
Count of Participants With Change in Peripheral Prostatic Specific Antigen (PSA)-Specific T Cell Responses CD8 IFNq	0 Participants
Count of Participants With Change in Peripheral Prostatic Specific Antigen (PSA)-Specific T Cell Responses CD8 IL2	0 Participants
Count of Participants With Change in Peripheral Prostatic Specific Antigen (PSA)-Specific T Cell Responses CD8 TNF	1 Participants

SECONDARY outcome

Timeframe: Baseline (pre vaccination) and post surgery after last dose of vaccine, approximately week 10

Population: Only 26 subjects had available tissue for analysis.

Prostate biopsy samples collected at baseline and at surgery after last dose of vaccine will be stained for analysis of immune cell infiltrate. Quantification will be reported as number of stained cells per micron squared of surface area.

Outcome measures

Outcome measures
Measure	Vaccine Plus Booster Shots n=26 Participants PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC PROSTVAC-V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.
Intraprostatic Treg Cell Infiltration With Cluster of Differentiation 4 (CD4)+Forkhead Box P3 (FOX-P3) Staining CD4 at baseline	199.8 Cell/mm(2) Standard Deviation 195.3
Intraprostatic Treg Cell Infiltration With Cluster of Differentiation 4 (CD4)+Forkhead Box P3 (FOX-P3) Staining CD4 at surgery after last dose of vaccine	237.6 Cell/mm(2) Standard Deviation 289.9
Intraprostatic Treg Cell Infiltration With Cluster of Differentiation 4 (CD4)+Forkhead Box P3 (FOX-P3) Staining FOX-P3 at baseline	16.93 Cell/mm(2) Standard Deviation 29.3
Intraprostatic Treg Cell Infiltration With Cluster of Differentiation 4 (CD4)+Forkhead Box P3 (FOX-P3) Staining FOX-P3 at surgery after last dose of vaccine	5.466 Cell/mm(2) Standard Deviation 4.524

SECONDARY outcome

Timeframe: Baseline (pre vaccination) and approximately week 10

Population: One subject came off-study prior to radical prostatectomy.

A change in PSA secondary to vaccination is defined as an increase or decrease in PSA value beyond the baseline level. PSA levels of 4.0 ng/ml and lower are considered normal.

Outcome measures

Outcome measures
Measure	Vaccine Plus Booster Shots n=26 Participants PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC PROSTVAC-V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.
Prostatic Specific Antigen (PSA) Changes Secondary to Vaccination PSA at Baseline	8.94 ng/mL Standard Deviation 9.96
Prostatic Specific Antigen (PSA) Changes Secondary to Vaccination PSA at 10 Weeks	10.18 ng/mL Standard Deviation 15.45

SECONDARY outcome

Timeframe: Baseline (pre vaccination) and approximately week 10

Population: 3 subjects did not have week 10 MRI performed.

MRI of the prostate was performed for changes in imaging characteristics of prostate cancer pre and post vaccination. MRI changes secondary to vaccination is defined as increase or decrease in the size of lesions from baseline (pre-vaccine) measurements.

Outcome measures

Outcome measures
Measure	Vaccine Plus Booster Shots n=24 Participants PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC PROSTVAC-V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.
Magnetic Resonance Imaging (MRI) Changes Secondary to Vaccination Largest lesion measurement at baseline	1.58 cm Standard Deviation 0.91
Magnetic Resonance Imaging (MRI) Changes Secondary to Vaccination Largest lesion measurement at 10 weeks	1.57 cm Standard Deviation 0.94

SECONDARY outcome

Timeframe: Date treatment consent signed to date off study, approximately 33 months and 5 days

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Vaccine Plus Booster Shots n=27 Participants PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC PROSTVAC-V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.
Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)	27 Participants

Adverse Events

Vaccine Plus Booster Shots

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vaccine Plus Booster Shots n=27 participants at risk PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC PROSTVAC-V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.
Vascular disorders Thromboembolic event	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.

Other adverse events

Other adverse events
Measure	Vaccine Plus Booster Shots n=27 participants at risk PROSTVAC-V/TRICOM followed by PROSTVAC-F/ TRICOM boost monthly until radical prostatectomy or off therapy PROSTVAC PROSTVAC-V/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-F/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.
Respiratory, thoracic and mediastinal disorders Cough	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Investigations Creatinine increased	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Gastrointestinal disorders Abdominal pain	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Investigations Alanine aminotransferase increased	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Immune system disorders Allergic reaction	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	7.4% 2/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Blood and lymphatic system disorders Anemia	33.3% 9/27 • Number of events 11 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Metabolism and nutrition disorders Anorexia	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Psychiatric disorders Anxiety	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 3/27 • Number of events 4 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Investigations Aspartate aminotransferase increased	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Musculoskeletal and connective tissue disorders Back pain	11.1% 3/27 • Number of events 3 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Renal and urinary disorders Bladder spasm	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Gastrointestinal disorders Bloating	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Investigations Blood bilirubin increased	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Eye disorders Blurred vision	7.4% 2/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Injury, poisoning and procedural complications Bruising	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Skin and subcutaneous tissue disorders Bullous dermatitis	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
General disorders Chills	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Investigations Cholesterol high	11.1% 3/27 • Number of events 3 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Gastrointestinal disorders Diarrhea	7.4% 2/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Nervous system disorders Dizziness	7.4% 2/27 • Number of events 3 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Nervous system disorders Dysgeusia	3.7% 1/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
General disorders Edema limbs	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Eye disorders Eye disorders - Other, Blepharitis	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Eye disorders Eye disorders - Other, Subconjunctival hemorrhage	7.4% 2/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Eye disorders Eye pain	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Injury, poisoning and procedural complications Fall	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
General disorders Fatigue	51.9% 14/27 • Number of events 20 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
General disorders Fever	29.6% 8/27 • Number of events 9 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
General disorders Flu like symptoms	63.0% 17/27 • Number of events 29 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Gastrointestinal disorders Gastroesophageal reflux disease	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Gastrointestinal disorders Gastrointestinal disorders - Other, H. Pylori	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Nervous system disorders Headache	11.1% 3/27 • Number of events 3 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Renal and urinary disorders Hematuria	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Investigations Hemoglobin increased	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Gastrointestinal disorders Hemorrhoids	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Metabolism and nutrition disorders Hypercalcemia	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Endocrine disorders Hyperparathyroidism	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Vascular disorders Hypertension	29.6% 8/27 • Number of events 15 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Metabolism and nutrition disorders Hypertriglyceridemia	11.1% 3/27 • Number of events 3 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Metabolism and nutrition disorders Hypocalcemia	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Metabolism and nutrition disorders Hypophosphatemia	14.8% 4/27 • Number of events 4 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
General disorders Injection site reaction	100.0% 27/27 • Number of events 83 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Psychiatric disorders Insomnia	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Investigations Lymphocyte count decreased	7.4% 2/27 • Number of events 4 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, muscle spasms	7.4% 2/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Musculoskeletal and connective tissue disorders Myalgia	7.4% 2/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Gastrointestinal disorders Nausea	7.4% 2/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
General disorders Pain	18.5% 5/27 • Number of events 7 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
General disorders Pain in extremity	14.8% 4/27 • Number of events 4 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Nervous system disorders Paresthesia	18.5% 5/27 • Number of events 5 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Reproductive system and breast disorders Pelvic pain	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Nervous system disorders Peripheral motor neuropathy	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Nervous system disorders Peripheral sensory neuropathy	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Investigations Platelet count decreased	11.1% 3/27 • Number of events 3 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Skin and subcutaneous tissue disorders Pruritus	7.4% 2/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Gastrointestinal disorders Rectal hemorrhage	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Renal and urinary disorders Renal and urinary disorders - Other, weak urine stream	3.7% 1/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Cardiac disorders Sinus bradycardia	11.1% 3/27 • Number of events 4 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Nervous system disorders Sinus pain	3.7% 1/27 • Number of events 3 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Cardiac disorders Sinus tachycardia	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, redness	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, erythema of right foot	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, rash	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, Specify	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Infections and infestations Skin infection	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Reproductive system and breast disorders Testicular pain	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Vascular disorders Thromboembolic event	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Renal and urinary disorders Urinary incontinence	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Renal and urinary disorders Urinary urgency	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Nervous system disorders Vasovagal reaction	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Gastrointestinal disorders Vomiting	3.7% 1/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Investigations White blood cell decreased	7.4% 2/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 33 months and 5 days.
Injury, poisoning and procedural complications Wound complication	3.7% 1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 33 months and 5 days.

Additional Information

Dr. Peter Pinto

National Cancer Institute

Phone: 301-496-6353

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place