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

NCT00199849 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 2005-0013LUD2002-006
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer; Bladder Cancer; Non-small Cell Lung Cancer; Esophageal Cancer; Sarcoma

Keywords

NY-ESO-1; DNA

Outcome Measures

Primary Outcomes (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.

  up to 13 weeks

Secondary Outcomes (4)

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

  13 weeks

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

  up to 13 weeks

• 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

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

  Up to 11 weeks

Study Arms (3)

Cohort 1

EXPERIMENTAL

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

Cohort 2

EXPERIMENTAL

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

Cohort 3

EXPERIMENTAL

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

Interventions

NY-ESO-1 Plasmid DNA Cancer Vaccine BIOLOGICAL

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.

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (2)

New York Presbyterian Hospital

New York, New York, 10021, United States

Location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 10655437 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Bladder Neoplasms; Carcinoma, Non-Small-Cell Lung; Esophageal Neoplasms; Sarcoma

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Urologic Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Results Point of Contact

• Title: Jonathan Skipper PhD
• Organization: Ludwig Institute for Cancer Research

jskipper@lcr.org

12124501539

Study Officials

• Padmanee Sharma, MD PhD

  UT MD Anderson Cancer Center Genitourinary Med Onc

  PRINCIPAL INVESTIGATOR

• Nasser K Altorki, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: September 27, 2004
• Primary Completion: September 11, 2006
• Study Completion: September 1, 2007
• Last Updated: October 10, 2022
• Results First Posted: October 8, 2021

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)