Trial Outcomes & Findings for NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine (NCT NCT00199849)

NCT ID: NCT00199849

Last Updated: 2022-10-10

Results Overview

All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published June 10, 2003). DLT was defined as * ≥ Grade 2 autoimmune phenomena * Asymptomatic bronchospasm or generalized urticaria * Grade ≥ non hematological toxicities (including injection site reactions) * Grade ≥ 3 hematological toxicities A dose-limiting adverse event must be definitely, probably, or possibly related to the administration of the investigational agent and must occur between first dose and 4 weeks after the last dose.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

18 participants

Primary outcome timeframe

up to 13 weeks

Results posted on

2022-10-10

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1 4 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 4 µg dosage of Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 4 X 1 µg PMEDs in close proximity. The vaccine was administered in weeks 1, 5, and 9.	Cohort 2 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 8 X 1 µg PMEDs. The vaccine was administered in weeks 1, 5, and 9.	Cohort 3 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as a cluster dosage of 4 doses (day 1, 3, 5, 8) as 2 X 1 µg PMEDs per day. The vaccine was administered in weeks 1, 5, and 9.
Overall Study STARTED	3	7	8
Overall Study COMPLETED	3	6	6
Overall Study NOT COMPLETED	0	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 2 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 8 X 1 µg PMEDs. The vaccine was administered in weeks 1, 5, and 9.	Cohort 3 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as a cluster dosage of 4 doses (day 1, 3, 5, 8) as 2 X 1 µg PMEDs per day. The vaccine was administered in weeks 1, 5, and 9.
Overall Study Unrelated illness or complication	1	0
Overall Study Progressive disease requiring intervention	0	1
Overall Study Did not meet eligibility criteria - not dosed	0	1

Baseline Characteristics

NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=3 Participants 4 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 4 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 4 X 1 µg PMEDs. The vaccine was administered in weeks 1, 5, and 9.	Cohort 2 n=7 Participants 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 8 X 1 µg PMEDs. The vaccine was administered in weeks 1, 5, and 9.	Cohort 3 n=7 Participants 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as a cluster dosage of 4 doses (day 1, 3, 5, 8) as 2 X 1 µg PMEDs per day. The vaccine was administered in weeks 1, 5, and 9.	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	10 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	15 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	16 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	17 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	3 participants n=5 Participants	7 participants n=7 Participants	7 participants n=5 Participants	17 participants n=4 Participants

PRIMARY outcome

Timeframe: up to 13 weeks

Population: All patients who received at least one dose of NY-ESO-1 Plasmid DNA Vaccine.

Outcome measures

Outcome measures
Measure	Cohort 1 n=3 Participants 4 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 4 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 4 X 1 µg PMEDs. The vaccine was administered in weeks 1, 5, and 9.	Cohort 2 n=7 Participants 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 8 X 1 µg PMEDs. The vaccine was administered in weeks 1, 5, and 9.	Cohort 3 n=7 Participants 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as a cluster dosage of 4 doses (day 1, 3, 5, 8) as 2 X 1 µg PMEDs per day. The vaccine was administered in weeks 1, 5, and 9.
Number of Patients With Dose Limiting Toxicities (DLTs) and Number of Patients With Adverse Events Number of patients reporting adverse events	3 Participants	7 Participants	7 Participants
Number of Patients With Dose Limiting Toxicities (DLTs) and Number of Patients With Adverse Events Number of patients with DLTs	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 13 weeks

Population: All patients who received at least one dose of NY-ESO-1 Plasmid DNA Vaccine and had valid tumor response measured.

Tumor response was assessed in patients with measurable tumors according to the Response Evaluation Criteria in Solid Tumors (RECIST). Computed tomography (CT) scans were performed at screening and at week 13. Response was assessed using RECIST version 1.0 (Therasse et al, J Natl Cancer Inst 2000; 92:205-16). Per RECIST, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions (no evaluable disease); partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria; no evidence of disease (NED): no new lesions in patients who did not have target lesions at baseline.

Outcome measures

Outcome measures
Measure	Cohort 1 n=3 Participants 4 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 4 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 4 X 1 µg PMEDs. The vaccine was administered in weeks 1, 5, and 9.	Cohort 2 n=6 Participants 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 8 X 1 µg PMEDs. The vaccine was administered in weeks 1, 5, and 9.	Cohort 3 n=7 Participants 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as a cluster dosage of 4 doses (day 1, 3, 5, 8) as 2 X 1 µg PMEDs per day. The vaccine was administered in weeks 1, 5, and 9.
Number of Patients With Tumor Response According to the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR)	0 Participants	0 Participants	0 Participants
Number of Patients With Tumor Response According to the Response Evaluation Criteria in Solid Tumors (RECIST). Partial Response (PR)	0 Participants	0 Participants	0 Participants
Number of Patients With Tumor Response According to the Response Evaluation Criteria in Solid Tumors (RECIST). Stable Disease (SD)	2 Participants	1 Participants	2 Participants
Number of Patients With Tumor Response According to the Response Evaluation Criteria in Solid Tumors (RECIST). Progressive Disease (PD)	1 Participants	2 Participants	5 Participants
Number of Patients With Tumor Response According to the Response Evaluation Criteria in Solid Tumors (RECIST). No Evidence of Disease (NED)	0 Participants	3 Participants	0 Participants

SECONDARY outcome

Timeframe: up to 13 weeks

Population: All patients who received at least one dose of NY-ESO-1 Plasmid DNA Vaccine and had baseline and at least one post-treatment sample taken. One patient in Cohort 3 did not have a baseline sample taken.

Blood samples were obtained at baseline (prior to the first dose), and in weeks 3, 5, 7, 9, 11 and 13 for the assessment of NY-ESO-1-specific antibodies by an enzyme-linked immunosorbent assay (ELISA). A positive response was a readable optical density at 280 nm.

Outcome measures

Outcome measures
Measure	Cohort 1 n=3 Participants 4 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 4 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 4 X 1 µg PMEDs. The vaccine was administered in weeks 1, 5, and 9.	Cohort 2 n=7 Participants 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 8 X 1 µg PMEDs. The vaccine was administered in weeks 1, 5, and 9.	Cohort 3 n=6 Participants 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as a cluster dosage of 4 doses (day 1, 3, 5, 8) as 2 X 1 µg PMEDs per day. The vaccine was administered in weeks 1, 5, and 9.
Number of Patients With NY-ESO-1-Specific Humoral Immunity as Determined by an Increase in Antibody Titer From Baseline. Number of patients with negative titers both pre-and post-treatment	3 Participants	7 Participants	6 Participants
Number of Patients With NY-ESO-1-Specific Humoral Immunity as Determined by an Increase in Antibody Titer From Baseline. Number of patients with negative titers at baseline and positive titers after treatment	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: up to 13 weeks

Population: All patients who received at least one dose of NY-ESO-1 Plasmid DNA Vaccine and had baseline and at least one post-treatment sample taken. One patient in Cohort 2 did not have samples taken. All patients did not have samples analyzed for CD8+ T-cell responses.

Blood samples were obtained at baseline (prior to the first dose), and in weeks 3, 5, 7, 9, 11 and 13 for the assessment of NY-ESO-1-specific CD4+ and CD8+ T-cell responses by ELISPOT.

Outcome measures

Outcome measures
Measure	Cohort 1 n=3 Participants 4 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 4 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 4 X 1 µg PMEDs. The vaccine was administered in weeks 1, 5, and 9.	Cohort 2 n=6 Participants 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 8 X 1 µg PMEDs. The vaccine was administered in weeks 1, 5, and 9.	Cohort 3 n=7 Participants 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as a cluster dosage of 4 doses (day 1, 3, 5, 8) as 2 X 1 µg PMEDs per day. The vaccine was administered in weeks 1, 5, and 9.
Number of Patients With NY-ESO-1-Specific Cellular Immunity as Measured by an Increase in NY-ESO-1-Specific CD4+ and CD8+ T-Cells Following Treatment. Number of patients with an increase in CD4+ T-cells	3 Participants	5 Participants	7 Participants
Number of Patients With NY-ESO-1-Specific Cellular Immunity as Measured by an Increase in NY-ESO-1-Specific CD4+ and CD8+ T-Cells Following Treatment. Number of patients without an increase in CD4+ T-cells	0 Participants	1 Participants	0 Participants
Number of Patients With NY-ESO-1-Specific Cellular Immunity as Measured by an Increase in NY-ESO-1-Specific CD4+ and CD8+ T-Cells Following Treatment. Number of patients with an increase in CD8+ T-cells	1 Participants	0 Participants	1 Participants
Number of Patients With NY-ESO-1-Specific Cellular Immunity as Measured by an Increase in NY-ESO-1-Specific CD4+ and CD8+ T-Cells Following Treatment. Number of patients without an increase in CD8+ T-cells	2 Participants	4 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to 11 weeks

Population: All patients who received at least one dose of NY-ESO-1 Plasmid DNA Vaccine and had baseline and at least one post-treatment sample taken.

Delayed-Type Hypersensitivity (DTH) testing was conducted at baseline and on days 15 and 72 of the study. A positive DTH reaction to NY-ESO-1 protein at baseline was absent in all patients. The presence of redness and induration was considered necessary for a positive DTH reaction.

Outcome measures

Outcome measures
Measure	Cohort 1 n=3 Participants 4 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 4 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 4 X 1 µg PMEDs. The vaccine was administered in weeks 1, 5, and 9.	Cohort 2 n=7 Participants 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 8 X 1 µg PMEDs. The vaccine was administered in weeks 1, 5, and 9.	Cohort 3 n=7 Participants 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as a cluster dosage of 4 doses (day 1, 3, 5, 8) as 2 X 1 µg PMEDs per day. The vaccine was administered in weeks 1, 5, and 9.
Number of Patients With Delayed-Type Hypersensitivity (DTH) Skin Reactions to NY-ESO-1 Protein Number of Patients With DTH Skin Reactions	0 Participants	3 Participants	1 Participants
Number of Patients With Delayed-Type Hypersensitivity (DTH) Skin Reactions to NY-ESO-1 Protein Number of Patients Without DTH Skin Reactions	3 Participants	4 Participants	6 Participants

Adverse Events

Cohort 1

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 2

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Cohort 3

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1 n=3 participants at risk 4 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 4 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 4 X 1 µg PMEDs. The vaccine was administered in weeks 1, 5, and 9.	Cohort 2 n=7 participants at risk 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as 8 X 1 µg PMEDs. The vaccine was administered in weeks 1, 5, and 9.	Cohort 3 n=7 participants at risk 8 µg NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 8 µg dosage of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered as a cluster dosage of 4 doses (day 1, 3, 5, 8) as 2 X 1 µg PMEDs per day. The vaccine was administered in weeks 1, 5, and 9.
General disorders Pyrexia	33.3% 1/3 • up to 13 weeks All Adverse Events (AEs) were to be documented in the source records and on the respective Case Report Form (CRF) pages. Events, which occurred after signed informed consent, but before first administration of study medication, were to be documented on the Pre-existing Signs and Symptoms CRF page. Thereafter, they were documented on the Adverse Event pages. AEs were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published June 10, 2003).	0.00% 0/7 • up to 13 weeks All Adverse Events (AEs) were to be documented in the source records and on the respective Case Report Form (CRF) pages. Events, which occurred after signed informed consent, but before first administration of study medication, were to be documented on the Pre-existing Signs and Symptoms CRF page. Thereafter, they were documented on the Adverse Event pages. AEs were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published June 10, 2003).	0.00% 0/7 • up to 13 weeks All Adverse Events (AEs) were to be documented in the source records and on the respective Case Report Form (CRF) pages. Events, which occurred after signed informed consent, but before first administration of study medication, were to be documented on the Pre-existing Signs and Symptoms CRF page. Thereafter, they were documented on the Adverse Event pages. AEs were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published June 10, 2003).
Renal and urinary disorders Bladder obstruction	0.00% 0/3 • up to 13 weeks All Adverse Events (AEs) were to be documented in the source records and on the respective Case Report Form (CRF) pages. Events, which occurred after signed informed consent, but before first administration of study medication, were to be documented on the Pre-existing Signs and Symptoms CRF page. Thereafter, they were documented on the Adverse Event pages. AEs were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published June 10, 2003).	14.3% 1/7 • up to 13 weeks All Adverse Events (AEs) were to be documented in the source records and on the respective Case Report Form (CRF) pages. Events, which occurred after signed informed consent, but before first administration of study medication, were to be documented on the Pre-existing Signs and Symptoms CRF page. Thereafter, they were documented on the Adverse Event pages. AEs were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published June 10, 2003).	0.00% 0/7 • up to 13 weeks All Adverse Events (AEs) were to be documented in the source records and on the respective Case Report Form (CRF) pages. Events, which occurred after signed informed consent, but before first administration of study medication, were to be documented on the Pre-existing Signs and Symptoms CRF page. Thereafter, they were documented on the Adverse Event pages. AEs were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published June 10, 2003).
Renal and urinary disorders Hemorrhage urinary tract	0.00% 0/3 • up to 13 weeks All Adverse Events (AEs) were to be documented in the source records and on the respective Case Report Form (CRF) pages. Events, which occurred after signed informed consent, but before first administration of study medication, were to be documented on the Pre-existing Signs and Symptoms CRF page. Thereafter, they were documented on the Adverse Event pages. AEs were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published June 10, 2003).	14.3% 1/7 • up to 13 weeks All Adverse Events (AEs) were to be documented in the source records and on the respective Case Report Form (CRF) pages. Events, which occurred after signed informed consent, but before first administration of study medication, were to be documented on the Pre-existing Signs and Symptoms CRF page. Thereafter, they were documented on the Adverse Event pages. AEs were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published June 10, 2003).	0.00% 0/7 • up to 13 weeks All Adverse Events (AEs) were to be documented in the source records and on the respective Case Report Form (CRF) pages. Events, which occurred after signed informed consent, but before first administration of study medication, were to be documented on the Pre-existing Signs and Symptoms CRF page. Thereafter, they were documented on the Adverse Event pages. AEs were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published June 10, 2003).
Gastrointestinal disorders Dysphagia	0.00% 0/3 • up to 13 weeks All Adverse Events (AEs) were to be documented in the source records and on the respective Case Report Form (CRF) pages. Events, which occurred after signed informed consent, but before first administration of study medication, were to be documented on the Pre-existing Signs and Symptoms CRF page. Thereafter, they were documented on the Adverse Event pages. AEs were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published June 10, 2003).	0.00% 0/7 • up to 13 weeks All Adverse Events (AEs) were to be documented in the source records and on the respective Case Report Form (CRF) pages. Events, which occurred after signed informed consent, but before first administration of study medication, were to be documented on the Pre-existing Signs and Symptoms CRF page. Thereafter, they were documented on the Adverse Event pages. AEs were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published June 10, 2003).	14.3% 1/7 • up to 13 weeks All Adverse Events (AEs) were to be documented in the source records and on the respective Case Report Form (CRF) pages. Events, which occurred after signed informed consent, but before first administration of study medication, were to be documented on the Pre-existing Signs and Symptoms CRF page. Thereafter, they were documented on the Adverse Event pages. AEs were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 3.0, published June 10, 2003).

Other adverse events

Additional Information

Jonathan Skipper PhD

Ludwig Institute for Cancer Research

Phone: 12124501539

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place