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)
18
Enrollment
2
Locations
3
Arms
35.1
Actual Duration (Months)
9
Patients Per Site
0.3
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

SiteCityStateCountryPostal Code
1New York Presbyterian HospitalNew YorkNew YorkUnited States10021
2UT MD Anderson Cancer CenterHoustonTexasUnited States77030

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

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

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleCohort 1Cohort 2Cohort 3
Arm/Group Description4 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
STARTED378
COMPLETED366
NOT COMPLETED012

Baseline Characteristics

Arm/Group TitleCohort 1Cohort 2Cohort 3Total
Arm/Group Description4 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 Participants37717
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
TitleNumber of Patients With Dose Limiting Toxicities (DLTs) and Number of Patients With Adverse Events
DescriptionAll 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 Frameup 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 TitleCohort 1Cohort 2Cohort 3
Arm/Group Description4 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 Participants377
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
TitleNumber of Patients With Tumor Response According to the Response Evaluation Criteria in Solid Tumors (RECIST).
DescriptionTumor 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 Frame13 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 TitleCohort 1Cohort 2Cohort 3
Arm/Group Description4 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 Participants367
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
TitleNumber of Patients With NY-ESO-1-Specific Humoral Immunity as Determined by an Increase in Antibody Titer From Baseline.
DescriptionBlood 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 Frameup 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 TitleCohort 1Cohort 2Cohort 3
Arm/Group Description4 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 Participants376
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
TitleNumber 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.
DescriptionBlood 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 Frameup 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 TitleCohort 1Cohort 2Cohort 3
Arm/Group Description4 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 Participants367
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
TitleNumber of Patients With Delayed-Type Hypersensitivity (DTH) Skin Reactions to NY-ESO-1 Protein
DescriptionDelayed-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 FrameUp 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 TitleCohort 1Cohort 2Cohort 3
Arm/Group Description4 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 Participants377
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 Frameup 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 TitleCohort 1Cohort 2Cohort 3
Arm/Group Description4 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 1Cohort 2Cohort 3
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/3 (0%) 0/7 (0%) 0/7 (0%)
Serious Adverse Events
Cohort 1Cohort 2Cohort 3
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total1/3 (33.3%) 1/7 (14.3%) 1/7 (14.3%)
Gastrointestinal disorders
Dysphagia0/3 (0%) 0/7 (0%) 1/7 (14.3%)
General disorders
Pyrexia1/3 (33.3%) 0/7 (0%) 0/7 (0%)
Renal and urinary disorders
Bladder obstruction0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Hemorrhage urinary tract0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Other (Not Including Serious) Adverse Events
Cohort 1Cohort 2Cohort 3
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total3/3 (100%) 7/7 (100%) 7/7 (100%)
Blood and lymphatic system disorders
Anemia0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Leukocytosis0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Leukopenia0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Cardiac disorders
Arrhythmia supraventricular0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Bradycardia0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Chest pain1/3 (33.3%) 0/7 (0%) 0/7 (0%)
Peripheral edema0/3 (0%) 1/7 (14.3%) 1/7 (14.3%)
Ear and labyrinth disorders
Eustachian tube dysfunction0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Endocrine disorders
Hyperglycemia0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Hypoglycemia0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Gastrointestinal disorders
Abdominal pain1/3 (33.3%) 0/7 (0%) 0/7 (0%)
Abdominal pain upper1/3 (33.3%) 0/7 (0%) 1/7 (14.3%)
Constipation0/3 (0%) 0/7 (0%) 2/7 (28.6%)
Diarrhea0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Nausea1/3 (33.3%) 0/7 (0%) 0/7 (0%)
Odynophagia0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Proctalgia0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Vomiting0/3 (0%) 0/7 (0%) 2/7 (28.6%)
General disorders
Chills1/3 (33.3%) 0/7 (0%) 0/7 (0%)
Fatigue2/3 (66.7%) 3/7 (42.9%) 4/7 (57.1%)
Hot flush0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Injection site reaction3/3 (100%) 7/7 (100%) 7/7 (100%)
Mucosal inflammation0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Pyrexia0/3 (0%) 0/7 (0%) 2/7 (28.6%)
Infections and infestations
Herpes zoster0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Infection1/3 (33.3%) 0/7 (0%) 0/7 (0%)
Sinusitis0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Injury, poisoning and procedural complications
Anthropod bite0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Investigations
Aspartate transaminase increased0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Bilirubin increased0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Blood magnesium decreased0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Blood phosphorus increased0/3 (0%) 0/7 (0%) 2/7 (28.6%)
Blood urea increased0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Blood uric acid increased0/3 (0%) 0/7 (0%) 2/7 (28.6%)
Lymphocyte count decreased0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Metabolism and nutrition disorders
Anorexia0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Muscle spasms0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Musculoskeletal pain0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Myalgia1/3 (33.3%) 1/7 (14.3%) 1/7 (14.3%)
Neck pain0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Nervous system disorders
Headache1/3 (33.3%) 1/7 (14.3%) 3/7 (42.9%)
Psychiatric disorders
Mood alteration1/3 (33.3%) 0/7 (0%) 0/7 (0%)
Renal and urinary disorders
Hematuria0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Pollakiuria0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Reproductive system and breast disorders
Perineal pain0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Prostatitis0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Respiratory, thoracic and mediastinal disorders
Cough1/3 (33.3%) 1/7 (14.3%) 4/7 (57.1%)
Dyspnea0/3 (0%) 1/7 (14.3%) 2/7 (28.6%)
Pharyngolaryngeal pain1/3 (33.3%) 0/7 (0%) 0/7 (0%)
Rhinitis1/3 (33.3%) 0/7 (0%) 0/7 (0%)
Sinus congestion0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Wheezing1/3 (33.3%) 1/7 (14.3%) 0/7 (0%)
Skin and subcutaneous tissue disorders
Dry skin0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Erythema0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Rash1/3 (33.3%) 2/7 (28.6%) 1/7 (14.3%)
Skin nodule0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Vascular disorders
Dizziness0/3 (0%) 1/7 (14.3%) 3/7 (42.9%)
Hypertension0/3 (0%) 0/7 (0%) 2/7 (28.6%)
Hypotension0/3 (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.

Results Point of Contact

Name/TitleMary Macri, Senior Director, Clinical Trials Management
OrganizationLudwig Institute for Cancer Research
Phone12124501546
Emailmmacri@lcr.org
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