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Prostate CancerPhase 1NCT00199849

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

A Phase 1 study testing NY-ESO-1 Plasmid DNA Cancer Vaccine in people with Prostate Cancer and Bladder Cancer, run by Ludwig Institute for Cancer Research at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NY-ESO-1 Plasmid DNA Cancer Vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
2 sitesUnited States
Study dates
27 Sep 2004to Sep 2007
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients were eligible for enrollment if they fulfilled all of the following criteria:
  • 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.
  • Advanced disease and have declined, delayed, failed or completed standard therapy.
  • Full recovery from surgery.
  • Expected survival of at least 6 months.
  • Karnofsky performance scale ≥ 60.
  • Adequate bone marrow, kidney, liver and immune functions.
  • Able and willing to give valid written informed consent.

Who cannot join

  • Clinically significant heart disease (NYHA Class III or IV).
  • Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding disorders, clinically significant liver or renal insufficiency requiring treatment.
  • Patients with serious intercurrent illness, requiring hospitalization.
  • Known HIV, Hepatitis B or Hepatitis C positivity.
  • History of autoimmune diseases (e.g. SLE, scleroderma). Vitiligo is not an exclusion criterion.
  • 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.
Show all 16Show fewer
  • Evidence of skin disease (e.g. psoriasis, eczema or keloid formation) at the proposed administration site.
  • Allergy to gold (including gold jewelry).
  • History or evidence of chrysotherapy (gold salts).
  • Chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to first dosing (6 weeks for nitrosoureas).
  • Other malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer, cervical carcinoma in situ.
  • 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.
  • Lack of availability for immunological and clinical follow-up assessments.
  • Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing.
  • Pregnancy or breastfeeding.
  • Women of childbearing potential: Refusal or inability to use effective means of contraception.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

  • New York Presbyterian Hospital

    New York, New York, 10021

Other trials in United States

About this study

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.

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.

Read the 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.

Being tested
NY-ESO-1 Plasmid DNA Cancer Vaccine
Keywords
NY-ESO-1, DNA
Medical subject headings
Prostatic Neoplasms, Urinary Bladder Neoplasms, Carcinoma, Non-Small-Cell Lung, Esophageal Neoplasms, Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NY-ESO-1 Plasmid DNA Cancer VaccineBiological

    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.

Study groups in NCT00199849
Study groupRoleWhat they receive
Cohort 1Experimental4 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.
Receives: Biological: NY-ESO-1 Plasmid DNA Cancer Vaccine
Cohort 2Experimental8 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.
Receives: Biological: NY-ESO-1 Plasmid DNA Cancer Vaccine
Cohort 3Experimental8 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.
Receives: Biological: NY-ESO-1 Plasmid DNA Cancer Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients With Dose Limiting Toxicities (DLTs) and Number of Patients With Adverse Events

    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.

    Measured: up to 13 weeks

Secondary outcomes (4)

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

    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.

    Measured: 13 weeks

  2. Number of Patients With NY-ESO-1-Specific Humoral Immunity as Determined by an Increase in Antibody Titer From Baseline.

    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.

    Measured: up to 13 weeks

  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.

    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.

    Measured: up to 13 weeks

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

    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.

    Measured: Up to 11 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2005 (estimated)
  2. Study start27 Sep 2004
  3. Primary completion11 Sep 2006
  4. Study completionSep 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00199849
Sponsor's protocol ID
2005-0013
Other IDs
LUD2002-006
Status last verified
Oct 2022
First submitted
12 Sep 2005
Last updated
10 Oct 2022
Data monitoring committee
No
FDA-regulated drug
Yes
Individual data sharing
No

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. doi: 10.1093/jnci/92.3.205.

    PubMed 10655437

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NY-ESO-1 Plasmid DNA Cancer Vaccine in people with Prostate Cancer and Bladder Cancer, run by Ludwig Institute for Cancer Research at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Dose Limiting Toxicities (DLTs) and Number of Patients With Adverse Events (time frame: up to 13 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00199849, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.

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