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

• Sponsor: Ludwig Institute for Cancer Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT00199849
• Collaborator: New York Presbyterian Hospital (Other), M.D. Anderson Cancer Center (Other), Memorial Sloan Kettering Cancer Center (Other)
• Enrollment: 18
• Locations: 2
• Arms: 3
• Actual Duration (Months): 35.1
• Patients Per Site: 9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

To evaluate the safety of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine given by particle-mediated epidermal delivery (PMED) in patients with tumor types known to express NY-ESO-1 or LAGE-1.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Bladder Cancer; Non-small Cell Lung Cancer; Esophageal Cancer; Sarcoma	Biological: NY-ESO-1 Plasmid DNA Cancer Vaccine	Phase 1

Detailed Description

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 microgram dosage of NY-ESO-1 was administered as 4 X 1 microgram PMEDs in close proximity. Similarly, the 8 microgram dosage was administered as 8 X 1 microgram PMEDs. The third cohort of patients received the 8 microgram dosage as a cluster dosage of 4 doses (day 1, 3, 5, 8) as 2 X 1 microgram PMEDs per day.

Blood samples were to be obtained at baseline, 2 weeks after each vaccination, prior to the second and third vaccination, and 4 weeks after the third vaccination for the assessment of clinical hematology, biochemistry measurements and immunology responses. Patients were to be evaluated for toxicity throughout the study.

Delayed-type hypersensitivity (DTH) testing was to be performed at baseline and at the 2-week visit following the first and third vaccinations.

NY-ESO-1 and/or LAGE-1 specific antibodies were to be assessed in all patients by an enzyme-linked immunosorbent assay (ELISA). NY-ESO-1 specific CD4+ and CD8+ T-cells were to be assessed in all patients by tetramer and/or ELISPOT assays.

Disease status was to be assessed at baseline and 4 weeks after the third vaccination in patients with measurable disease.

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Immunological Evaluation of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine Given by Particle-mediated Epidermal Delivery (PMED) in Patients With Tumor Type Known to Express NY-ESO-1 or LAGE-1 Antigen.
• Actual Study Start Date: Sep 27, 2004
• Actual Primary Completion Date: Sep 11, 2006
• Actual Study Completion Date: Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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 NY-ESO-1 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 of Cycle 1. In the absence of > Grade 3 toxicity and in the absence of progressive disease requiring other treatment or the presence of NY-ESO-1 immunity, patients could receive an additional cycle of vaccinations of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine.	Biological: NY-ESO-1 Plasmid DNA Cancer Vaccine; NY-ESO-1 Plasmid DNA Cancer Vaccine administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device.
Experimental: 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 of Cycle 1. In the absence of > Grade 3 toxicity and in the absence of progressive disease requiring other treatment or the presence of NY-ESO-1 immunity, patients could receive an additional cycle of vaccinations of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine.	Biological: NY-ESO-1 Plasmid DNA Cancer Vaccine; NY-ESO-1 Plasmid DNA Cancer Vaccine administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device.
Experimental: 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 of Cycle 1. In the absence of > grade 3 toxicity and in the absence of progressive disease requiring other treatment or the presence of NY-ESO-1 immunity, patients could receive an additional cycle of vaccinations of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine.	Biological: NY-ESO-1 Plasmid DNA Cancer Vaccine; NY-ESO-1 Plasmid DNA Cancer Vaccine administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device.

Outcome Measures

Primary Outcome Measures

1. Number of Patients With Dose Limiting Toxicities (DLTs) and Number of Patients With Adverse Events [up to 13 weeks]

   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.

Secondary Outcome Measures

1. Number of Patients With Tumor Response According to the Response Evaluation Criteria in Solid Tumors (RECIST). [13 weeks]

   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.

2. Number of Patients With NY-ESO-1-Specific Humoral Immunity as Determined by an Increase in Antibody Titer From Baseline. [up to 13 weeks]

   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.

3. 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. [up to 13 weeks]

   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.

4. Number of Patients With Delayed-Type Hypersensitivity (DTH) Skin Reactions to NY-ESO-1 Protein [Up to 11 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Patients were eligible for enrollment if they fulfilled all of the following criteria:

1. Histologically proven tumor type known to express NY-ESO-1 or LAGE-1 (prostate cancer, breast cancer, bladder cancer, hepatocellular cancer, synovial sarcoma, leiomyosarcoma, head and neck, lung cancer, esophageal, ovarian, neuroblastoma); or NY-ESO-1 or LAGE-1 positive tumors determined by reverse transcriptase and polymerase chain reaction (RT-PCR) analysis, preferably, or immunohistochemistry or expression of LAGE-1 by RT-PCR.

2. Advanced disease and have declined, delayed, failed or completed standard therapy.

3. Full recovery from surgery.

4. Expected survival of at least 6 months.

5. Karnofsky performance scale ≥ 60.

6. Adequate bone marrow, kidney, liver and immune functions.

7. Able and willing to give valid written informed consent.

Exclusion Criteria:

1. Clinically significant heart disease (NYHA Class III or IV).

2. Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding disorders, clinically significant liver or renal insufficiency requiring treatment.

3. Patients with serious intercurrent illness, requiring hospitalization.

4. Known HIV, Hepatitis B or Hepatitis C positivity.

5. History of autoimmune diseases (e.g. SLE, scleroderma). Vitiligo is not an exclusion criterion.

6. Concomitant systemic treatment with corticosteroids, anti-histaminic drugs or non-steroidal anti-inflammatory drugs. Specific COX-2 inhibitors are permitted. Low dose aspirin is permitted. Topical or inhalational steroids are permitted.

7. Evidence of skin disease (e.g. psoriasis, eczema or keloid formation) at the proposed administration site.

8. Allergy to gold (including gold jewelry).

9. History or evidence of chrysotherapy (gold salts).

10. Chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to first dosing (6 weeks for nitrosoureas).

11. Other malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer, cervical carcinoma in situ.

12. Mental impairment, in the opinion of the investigator, that may compromise the ability to give informed consent and comply with the requirements of the study.

13. Lack of availability for immunological and clinical follow-up assessments.

14. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing.

15. Pregnancy or breastfeeding.

16. Women of childbearing potential: Refusal or inability to use effective means of contraception.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York Presbyterian Hospital	New York	New York	United States	10021
2	UT MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• Ludwig Institute for Cancer Research
• New York Presbyterian Hospital
• M.D. Anderson Cancer Center
• Memorial Sloan Kettering Cancer Center

Investigators

• Principal Investigator: Padmanee Sharma, MD PhD, UT MD Anderson Cancer Center Genitourinary Med Onc
• Principal Investigator: Nasser K Altorki, MD, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16.

• Responsible Party: Ludwig Institute for Cancer Research
• ClinicalTrials.gov Identifier: NCT00199849
• Other Study ID Numbers: 2005-0013; LUD2002-006
• First Posted: Sep 20, 2005
• Last Update Posted: Oct 8, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Keywords provided by Ludwig Institute for Cancer Research: NY-ESO-1; DNA

Study Results

Participant Flow

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3
Arm/Group Description	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.	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.	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.
Period Title: Overall Study
STARTED	3	7	8
COMPLETED	3	6	6
NOT COMPLETED	0	1	2

Baseline Characteristics

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Total
Arm/Group Description	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.	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.	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 of all reporting groups
Overall Participants	3	7	7	17
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	2 66.7%	3 42.9%	5 71.4%	10 58.8%
>=65 years	1 33.3%	4 57.1%	2 28.6%	7 41.2%
Sex: Female, Male (Count of Participants)
Female	2 66.7%	0 0%	0 0%	2 11.8%
Male	1 33.3%	7 100%	7 100%	15 88.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	1 14.3%	1 5.9%
Not Hispanic or Latino	3 100%	7 100%	6 85.7%	16 94.1%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	3 100%	7 100%	7 100%	17 100%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	3 100%	7 100%	7 100%	17 100%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Dose Limiting Toxicities (DLTs) and Number of Patients With Adverse Events
Description	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.
Time Frame	up to 13 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3
Arm/Group Description	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.	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.	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.
Measure Participants	3	7	7
Number of patients with DLTs	0 0%	0 0%	0 0%
Number of patients reporting adverse events	3 100%	7 100%	7 100%

2. Secondary Outcome

Title	Number of Patients With Tumor Response According to the Response Evaluation Criteria in Solid Tumors (RECIST).
Description	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.
Time Frame	13 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3
Arm/Group Description	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.	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.	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.
Measure Participants	3	6	7
Complete Response (CR)	0 0%	0 0%	0 0%
Partial Response (PR)	0 0%	0 0%	0 0%
Stable Disease (SD)	2 66.7%	1 14.3%	2 28.6%
Progressive Disease (PD)	1 33.3%	2 28.6%	5 71.4%
No Evidence of Disease (NED)	0 0%	3 42.9%	0 0%

3. Secondary Outcome

Title	Number of Patients With NY-ESO-1-Specific Humoral Immunity as Determined by an Increase in Antibody Titer From Baseline.
Description	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.
Time Frame	up to 13 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3
Arm/Group Description	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.	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.	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.
Measure Participants	3	7	6
Number of patients with negative titers both pre-and post-treatment	3 100%	7 100%	6 85.7%
Number of patients with negative titers at baseline and positive titers after treatment	0 0%	0 0%	0 0%

4. Secondary Outcome

Title	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.
Description	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.
Time Frame	up to 13 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3
Arm/Group Description	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.	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.	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.
Measure Participants	3	6	7
Number of patients with an increase in CD4+ T-cells	3 100%	5 71.4%	7 100%
Number of patients without an increase in CD4+ T-cells	0 0%	1 14.3%	0 0%
Number of patients with an increase in CD8+ T-cells	1 33.3%	0 0%	1 14.3%
Number of patients without an increase in CD8+ T-cells	2 66.7%	4 57.1%	4 57.1%

5. Secondary Outcome

Title	Number of Patients With Delayed-Type Hypersensitivity (DTH) Skin Reactions to NY-ESO-1 Protein
Description	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.
Time Frame	Up to 11 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3
Arm/Group Description	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.	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.	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.
Measure Participants	3	7	7
Number of Patients With DTH Skin Reactions	0 0%	3 42.9%	1 14.3%
Number of Patients Without DTH Skin Reactions	3 100%	4 57.1%	6 85.7%

Adverse Events

Time Frame	up to 13 weeks
Adverse Event Reporting Description	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).
Arm/Group Title	Cohort 1		Cohort 2		Cohort 3
Arm/Group Description	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.		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.		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.
All Cause Mortality
	Cohort 1		Cohort 2		Cohort 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/7 (0%)		0/7 (0%)
Serious Adverse Events
	Cohort 1		Cohort 2		Cohort 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/3 (33.3%)		1/7 (14.3%)		1/7 (14.3%)
Gastrointestinal disorders
Dysphagia	0/3 (0%)		0/7 (0%)		1/7 (14.3%)
General disorders
Pyrexia	1/3 (33.3%)		0/7 (0%)		0/7 (0%)
Renal and urinary disorders
Bladder obstruction	0/3 (0%)		1/7 (14.3%)		0/7 (0%)
Hemorrhage urinary tract	0/3 (0%)		1/7 (14.3%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Cohort 1		Cohort 2		Cohort 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100%)		7/7 (100%)		7/7 (100%)
Blood and lymphatic system disorders
Anemia	0/3 (0%)		0/7 (0%)		1/7 (14.3%)
Leukocytosis	0/3 (0%)		1/7 (14.3%)		0/7 (0%)
Leukopenia	0/3 (0%)		0/7 (0%)		1/7 (14.3%)
Cardiac disorders
Arrhythmia supraventricular	0/3 (0%)		0/7 (0%)		1/7 (14.3%)
Bradycardia	0/3 (0%)		0/7 (0%)		1/7 (14.3%)
Chest pain	1/3 (33.3%)		0/7 (0%)		0/7 (0%)
Peripheral edema	0/3 (0%)		1/7 (14.3%)		1/7 (14.3%)
Ear and labyrinth disorders
Eustachian tube dysfunction	0/3 (0%)		0/7 (0%)		1/7 (14.3%)
Endocrine disorders
Hyperglycemia	0/3 (0%)		1/7 (14.3%)		0/7 (0%)
Hypoglycemia	0/3 (0%)		1/7 (14.3%)		0/7 (0%)
Gastrointestinal disorders
Abdominal pain	1/3 (33.3%)		0/7 (0%)		0/7 (0%)
Abdominal pain upper	1/3 (33.3%)		0/7 (0%)		1/7 (14.3%)
Constipation	0/3 (0%)		0/7 (0%)		2/7 (28.6%)
Diarrhea	0/3 (0%)		0/7 (0%)		1/7 (14.3%)
Nausea	1/3 (33.3%)		0/7 (0%)		0/7 (0%)
Odynophagia	0/3 (0%)		0/7 (0%)		1/7 (14.3%)
Proctalgia	0/3 (0%)		0/7 (0%)		1/7 (14.3%)
Vomiting	0/3 (0%)		0/7 (0%)		2/7 (28.6%)
General disorders
Chills	1/3 (33.3%)		0/7 (0%)		0/7 (0%)
Fatigue	2/3 (66.7%)		3/7 (42.9%)		4/7 (57.1%)
Hot flush	0/3 (0%)		0/7 (0%)		1/7 (14.3%)
Injection site reaction	3/3 (100%)		7/7 (100%)		7/7 (100%)
Mucosal inflammation	0/3 (0%)		0/7 (0%)		1/7 (14.3%)
Pyrexia	0/3 (0%)		0/7 (0%)		2/7 (28.6%)
Infections and infestations
Herpes zoster	0/3 (0%)		1/7 (14.3%)		0/7 (0%)
Infection	1/3 (33.3%)		0/7 (0%)		0/7 (0%)
Sinusitis	0/3 (0%)		1/7 (14.3%)		0/7 (0%)
Injury, poisoning and procedural complications
Anthropod bite	0/3 (0%)		1/7 (14.3%)		0/7 (0%)
Investigations
Aspartate transaminase increased	0/3 (0%)		0/7 (0%)		1/7 (14.3%)
Bilirubin increased	0/3 (0%)		0/7 (0%)		1/7 (14.3%)
Blood magnesium decreased	0/3 (0%)		0/7 (0%)		1/7 (14.3%)
Blood phosphorus increased	0/3 (0%)		0/7 (0%)		2/7 (28.6%)
Blood urea increased	0/3 (0%)		0/7 (0%)		1/7 (14.3%)
Blood uric acid increased	0/3 (0%)		0/7 (0%)		2/7 (28.6%)
Lymphocyte count decreased	0/3 (0%)		1/7 (14.3%)		0/7 (0%)
Metabolism and nutrition disorders
Anorexia	0/3 (0%)		1/7 (14.3%)		0/7 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/3 (0%)		0/7 (0%)		1/7 (14.3%)
Muscle spasms	0/3 (0%)		0/7 (0%)		1/7 (14.3%)
Musculoskeletal pain	0/3 (0%)		0/7 (0%)		1/7 (14.3%)
Myalgia	1/3 (33.3%)		1/7 (14.3%)		1/7 (14.3%)
Neck pain	0/3 (0%)		0/7 (0%)		1/7 (14.3%)
Nervous system disorders
Headache	1/3 (33.3%)		1/7 (14.3%)		3/7 (42.9%)
Psychiatric disorders
Mood alteration	1/3 (33.3%)		0/7 (0%)		0/7 (0%)
Renal and urinary disorders
Hematuria	0/3 (0%)		1/7 (14.3%)		0/7 (0%)
Pollakiuria	0/3 (0%)		1/7 (14.3%)		0/7 (0%)
Reproductive system and breast disorders
Perineal pain	0/3 (0%)		0/7 (0%)		1/7 (14.3%)
Prostatitis	0/3 (0%)		1/7 (14.3%)		0/7 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	1/3 (33.3%)		1/7 (14.3%)		4/7 (57.1%)
Dyspnea	0/3 (0%)		1/7 (14.3%)		2/7 (28.6%)
Pharyngolaryngeal pain	1/3 (33.3%)		0/7 (0%)		0/7 (0%)
Rhinitis	1/3 (33.3%)		0/7 (0%)		0/7 (0%)
Sinus congestion	0/3 (0%)		0/7 (0%)		1/7 (14.3%)
Wheezing	1/3 (33.3%)		1/7 (14.3%)		0/7 (0%)
Skin and subcutaneous tissue disorders
Dry skin	0/3 (0%)		0/7 (0%)		1/7 (14.3%)
Erythema	0/3 (0%)		0/7 (0%)		1/7 (14.3%)
Rash	1/3 (33.3%)		2/7 (28.6%)		1/7 (14.3%)
Skin nodule	0/3 (0%)		1/7 (14.3%)		0/7 (0%)
Vascular disorders
Dizziness	0/3 (0%)		1/7 (14.3%)		3/7 (42.9%)
Hypertension	0/3 (0%)		0/7 (0%)		2/7 (28.6%)
Hypotension	0/3 (0%)		0/7 (0%)		1/7 (14.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.