Clinical Trials

Text Size A A

E-Mail to a Friend






secret  Click to Play Audio


Sarcoma

ID-LV305 for Locally Advanced, Relapsed or Metastatic Cancer Expressing NY-ESO-1
A Phase 1 Safety Study of Intradermal ID-LV305 in Patients With Locally Advanced, Relapsed or Metastatic Cancer Expressing NY-ESO-1
Status Conditions Phase Study ID
Recruiting Breast Cancer
Melanoma
Non-small Cell Lung Cancer
Ovarian Cancer
Sarcoma
Phase I NCT02122861
Summary

This is a Phase 1 multi-center study to evaluate the clinical safety and immune response of ID-LV305 when injected intradermally in patients with advanced cancer. ID-LV305 is a novel immunotherapy agent designed to target dendritic cells and stimulate the body's immune system to fight the spread and growth of cancer for patients whose tumors express the NY-ESO-1 protein. Patients with melanoma, sarcoma, ovarian cancer, breast cancer or non-small cell lung cancer that express NY-ESO-1 may be considered for the trial.


Investigator
Seth M. Pollack, MD
Location    
SCCA Phase 1 Program Office 206-288-7551 Refer Patient
Eligibility Criteria (must meet the following to participate in this study)
  • Locally advanced, relapsed, and/or metastatic cancer with low or minimal tumor burden
  • Tumor histology consistent with one of the following: breast cancer, melanoma, non-small cell lung cancer (NSCLC), ovarian cancer or sarcoma
  • Tumor specimen positive for NY-ESO-1 expression by IHC and/or RT-PCR
  • If ovarian cancer, cancer antigen 125 (CA-125) must be ≥ 40 U/mL, or if melanoma, LDH must be ≤ ULN
  • 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 either an inadequate response and/or unacceptable toxicity with two or more prior systemic, surgical, or radiation cancer therapies
  • ≥ 18 years of age
  • Life expectancy of ≥ 6 months per the investigator
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • ECG without evidence of clinically significant arrhythmia or ischemia
  • If female of childbearing potential (FCBP), willing to undergo pregnancy testing and agrees to use at least one highly effective or two effective contraceptive methods during the dosing period and for three months after last ID-LV305 injection
  • If male and sexually active with a FCBP, must agree to use highly effective contraception such as latex condom during the dosing period and for three months after last ID-LV305 injection
Exclusions (conditions that would prevent participation in this study)
  • Investigational therapy within 3 weeks prior to ID-LV305 dosing
  • Prior administration of other NY-ESO-1-targeting immunotherapeutics
  • Significant immunosuppression from:

    1. Concurrent, recent (≤ 4 weeks ago) or anticipated treatment with systemic corticosteroids at any dose, or
    2. Other immunosuppressive medications such as methotrexate, cyclosporine, azathioprine (antihistamines, non-steroidal anti- inflammatory drugs and aspirin permitted) or conditions such as common variable hypogammaglobulinemia or exposures such as large field radiotherapy
  • Cancer therapies, including chemotherapy, radiation, biologics or kinase inhibitors, G-CSF or GM-CSF within 3 weeks prior to the first scheduled ID-LV305 dosing
  • Psychiatric, other medical illness or other condition that in the opinion of the PI prevents compliance with study procedures or ability to provide valid informed consent
  • Significant autoimmune disease with the exception of alopecia, vitiligo, hypothyroidism or other conditions that have never been clinically active and require no ongoing therapy
  • Myocardial infarction within 6 months of study initiation, active cardiac ischemia or New York Heart Association (NYHA) Grade III or IV heart failure
  • Inadequate organ function including:

    1. Marrow: Peripheral blood leukocyte count (WBC) < 3000/mm3, absolute neutrophils count ≤ 1500/mm3, platelets < 75000/mm3, or hemoglobin < 10 gm/dL
    2. Hepatic: alanine aminotransferase (ALT), and aspartate aminotransferase (AST) > 2.5 x ULN, total serum bilirubin > 1.5 x ULN (patients with Gilbert's Disease may be included if their total bilirubin is ≤ 3.0 mg/dL)
    3. Renal: Creatinine > 1.5x ULN
    4. Other: INR (prothrombin time ratio) or partial thromboplastin time (PTT) >1.5 x ULN
  • History of other cancer within 3 years (except non-melanoma cutaneous malignancies and cervical carcinoma in situ)
  • Active tuberculosis or recent (< 2 week ago) clinically significant infection or evidence of active hepatitis B, hepatitis C or HIV infection
  • Uveal melanoma
  • Brain metastases considered unstable as:

    1. Without confirmed stability over 60 days in patients previously treated with prior surgery or radiation; OR
    2. Associated with symptoms and/or findings; OR
    3. Requiring corticosteroids or anticonvulsants in the prior 60 days
  • Pregnancy or nursing
Last Updated
May 06, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.