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A Phase 1 Trial of NY-ESO-1 With GLA-SE in Patients With Unresectable or Metastatic Cancer

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ClinicalTrials.gov Identifier: NCT02015416
Recruitment Status : Completed
First Posted : December 19, 2013
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a Phase I, multi-center, multiple ascending dose study to evaluate the clinical safety and immune response of IDC-G305 when injected intramuscularly in patients with unresectable or metastatic cancer. IDC-G305 is an immunotherapy consisting of recombinant NY-ESO-1 antigen and the adjuvant, GLA-SE. The goal is for IDC-G305 to stimulate the body's immune system to fight the spread and growth of cancer for patients whose tumors include the NY-ESO-1 protein. Patients with melanoma, ovarian, renal cell or non-small cell lung cancer may be considered for the trial.

Condition or disease Intervention/treatment Phase
Melanoma Ovarian Cancer Sarcoma Non-small Cell Lung Cancer Breast Cancer Biological: IDC-G305 Phase 1

Detailed Description:

This is a Phase 1, open label, multicenter, multiple ascending dose trial of IDC-G305 administered by intramuscular injection in a 3+3 sequential dose escalation design. IDC-G305 is an immunotherapy consisting of recombinant NY-ESO-1 antigen and the adjuvant, GLA-SE. Patients with unresectable, relapsed or metastatic cancer but with low disease burden and indolent disease course may be considered for the trial. Tumors must express the NY-ESO-1 gene signature and tumor types that will be studied are: melanoma, ovarian, sarcoma,non-small cell lung and breast cancer.

Each of three dose level cohorts will be treated contingent upon absence of dose limiting toxicity (DLT) and acceptable safety data for the preceding cohort. Initially, three patients will be scheduled to receive IDC-G305 in each dose level cohort. Dose escalation will be contingent upon the assessment of safety data obtained during the initial injections.

Patients will be evaluated at baseline and at regular intervals for safety and immune response. Both cellular and humoral immunogenicity will be explored.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Phase 1, open label, multicenter ascending dose study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Open Label, Multicenter, Multiple Ascending Dose Trial Evaluating the Safety, Tolerability and Immunogenicity of Intramuscular Recombinant NY-ESO-1 Protein With GLA-SE Adjuvant in Patients With Unresectable or Metastatic Cancer
Actual Study Start Date : November 2013
Primary Completion Date : December 2016
Study Completion Date : March 2017


Arms and Interventions

Arm Intervention/treatment
Experimental: IDC-G305
NY-ESO-1 recombinant protein together with GLA-SE
Biological: IDC-G305
NY-ESO-1 recombinant protein together with GLA-SE


Outcome Measures

Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: Up to 1 year after last vaccination ]
    To evaluate the safety and tolerability of multiple ascending doses of intramuscular (IM) IDC-G305


Secondary Outcome Measures :
  1. Immunogenicity [ Time Frame: Approximately 12 weeks ]
    The secondary objective is to evaluate the humoral and cellular immunogenicity of multiple ascending doses of intramuscularly administered IDC-G305


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of melanoma, ovarian cancer, sarcoma, breast cancer or non-small cell lung cancer (NSCLC)
  • Unresectable, relapsed and/or metastatic cancer with minimal or low disease burden. Disease may or may not be measurable and should not be rapidly progressive. Inadequate response, relapse and/or unacceptable toxicity with one or more prior systemic, surgical, or radiation cancer therapies, except patients with NSCLC and breast cancer who must have experienced an inadequate response and/or unacceptable toxicity with two or more prior systemic, surgical, or radiation cancer therapies.
  • Cancer expresses NY-ESO-1
  • ≥ 18 years of age
  • Life expectancy of ≥ 6 months
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • ECG without evidence of clinically significant arrhythmia or ischemia
  • Negative pregnancy test for females of childbearing potential

Exclusion Criteria:

  • Pregnant or nursing
  • Vaccine or other therapy directed against NY-ESO-1 at any time in the past and any investigational therapy within three weeks prior to IDC-G305 dosing
  • Significant immunosuppression
  • Cancer chemotherapy, G-CSF or GM-CSF within three weeks prior to the first study treatment
  • Significant autoimmune disease
  • Myocardial infarction within six months of treatment, active cardiac ischemia or Grade III or IV heart failure
  • Inadequate hematology or chemistry profiles
  • History of other cancer within three years
  • Active, concurrent or recent infection, including tuberculosis, hepatitis B, hepatitis C or HIV
  • Uveal melanoma
  • Brain metastases considered unstable
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02015416


Locations
United States, Arizona
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Immune Design
Investigators
Principal Investigator: Kunle Odunsi, MD PhD Roswell Park Cancer Institute
More Information

Responsible Party: Immune Design
ClinicalTrials.gov Identifier: NCT02015416     History of Changes
Other Study ID Numbers: IDC-G305-2013-001
First Posted: December 19, 2013    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Immune Design:
Melanoma
Ovarian cancer
Sarcoma
Non-small cell lung cancer
NSCLC
Breast cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Melanoma
Sarcoma
Ovarian Neoplasms
Neoplasm Metastasis
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Connective and Soft Tissue
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplastic Processes