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Multi-center Phase I/IIa Trial of an Autologous Tumor Lysate (TL) + Yeast Cell Wall Particles (YCWP) + Dendritic Cells (DC) Vaccine in Addition to Standard of Care Checkpoint Inhibitor of Choice in Metastatic Melanoma Patients With Measurable Disease.

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ClinicalTrials.gov Identifier: NCT02678741
Recruitment Status : Active, not recruiting
First Posted : February 10, 2016
Last Update Posted : August 9, 2019
Sponsor:
Collaborator:
Elios Therapeutics, LLC
Information provided by (Responsible Party):
Cancer Insight, LLC

Brief Summary:
Assess the safety and tumor response of utilizing an autologous tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine given in combination with standard of care (SoC) checkpoint inhibitors (CPI) in patients with stage IV melanoma with measurable disease.

Condition or disease Intervention/treatment Phase
Metastatic Melanoma Drug: TLPLDC Vaccine Phase 1 Phase 2

Detailed Description:

Metastatic melanoma patients eligible for (or currently on) CPI therapy per SoC will be identified and screened for inclusion/exclusion criteria. Eligible patients will be counseled and consented for tissue procurement. They will undergo excisional or core needle biopsy as clinically indicated and this tissue will be shipped in liquid nitrogen shippers through FedEx to our central facility in Greenville, SC.The tumor will be stored frozen until vaccine preparation. Vaccine development requires 48 hours for preparation. Upon verification that adequate tissue was obtained, these patients will then be counseled and consented for participation in the trial.

The patients who qualify for participation in this trial will continue their treatment of CPI. Once consented, patients will receive a single injection of Neupogen (G-CSF) 300 μg SQ 24-48 hrs prior to having 70 mL of blood collected and sent to our central facility for DC isolation and preparation. Those who cannot tolerate Neupogen or refuse it will have 120 mL of blood drawn and sent. Additional blood may be drawn if additional vaccine doses need to be made or re-made for any reason. Vaccines will be prepared by producing TL through freeze/thaw cycling and then loaded into pre-prepared YCWP. The TL-loaded YCWP will be introduced to the DC for phagocytosis thus creating the TLPLDC vaccine, which will be frozen in single dose vials. Each vial will contain 1 x 106 TLPLDC and will be labeled with the patient's unique study number.

The frozen autologous TLPLDC will be sent back to the site with a total of 6 single dose vials after the vaccine has completed QA/QC testing and lot-release (usually 3 weeks). The primary vaccination series will include monthly inoculations at 0, 1, 2, 3 months followed by boosters at 6 and 9 months in the same lymph node draining area (preferably the anterior thigh). Once received, the first inoculation should occur within 4 weeks.

Safety data will be collected on local and systemic toxicities and graded and reported per the Common Terminology Criteria for Adverse Events (CTCAE) v4.03.

Patients will follow-up at their respective sites for evaluation of metastatic disease per SoC. They will under imaging, CT/PET-CT, to meet Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 and iRECIST to monitor disease.

Blood (50 mL) will be collected from all patients prior to each inoculation and at 12 months from enrollment for a total of 7 time points or a total of 350 mL of blood over 1 year. The collected blood will be sent to our central facility for immunologic testing of T-cell responses.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-center Phase I/IIa Trial of an Autologous Tumor Lysate (TL) + Yeast Cell Wall Particles (YCWP) + Dendritic Cells (DC) Vaccine in Addition to Standard of Care Checkpoint Inhibitor of Choice in Metastatic Melanoma Patients With Measurable Disease.
Study Start Date : February 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Active Comparator: No clinical response
No clinical response (PD de novo) after a minimum of 3 months on CPI monotherapy
Drug: TLPLDC Vaccine
Tumor Lysate, Particle Loaded, Dendritic Cell Vaccine

Active Comparator: Develop PD
Develop PD after initial clinical response to CPI monotherapy
Drug: TLPLDC Vaccine
Tumor Lysate, Particle Loaded, Dendritic Cell Vaccine

Active Comparator: Stable Disease
Stable disease for at least 6 months on CPI monotherapy
Drug: TLPLDC Vaccine
Tumor Lysate, Particle Loaded, Dendritic Cell Vaccine




Primary Outcome Measures :
  1. Graded Standard Local and Systemic Toxicities (using CTCAE graded toxicity scale) months [ Time Frame: 12 months (1 year) ]
    Safety of adding the TLPLDC vaccine to SoC CPI monotherapy


Secondary Outcome Measures :
  1. Tumor Response to Treatment Using Response Evaluation Criteria in Solid Tumors (RECIST) criteria [ Time Frame: 12 months (1 year) ]
    RECIST criteria is used for assessing tumor response in the addition of TLPLDC vaccine



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Appendix A)
  • Metastatic melanoma eligible for {or currently on} standard of care CPI therapy (treating physician's choice) with measurable disease.
  • Approximately 1 cm3 preferred but 1 mg minimum of accessible and dispensable tumor (minimum of 3 passes with a core needle)
  • Able to tolerate CPI treatment regimen {if already started}
  • Adequate organ function as determined by the following laboratory values:
  • ANC ≥ 1,000/μL
  • Platelets ≥ 75,000/μL
  • Hgb ≥ 9 g/dL
  • Creatinine ≤ 1.5 x upper limit of normal (ULN) or Creatinine clearance ≥ 50% of lower limit of normal (LLN)
  • Total bilirubin ≤ 1.5 ULN
  • ALT and AST ≤ 1.5 ULN
  • For women of child-bearing potential, agreement to use adequate birth control (abstinence, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, oral contraception, IUD, or use of condoms or diaphragms)

Exclusion Criteria:

  • Inability to tolerate CPI therapy {if already started}
  • Rapidly progressing multi-focal metastatic melanoma
  • Insufficient tumor available to produce vaccine
  • ECOG >2 performance status (Appendix A)
  • Immune deficiency disease or known history of HIV, HBV, HCV
  • Receiving immunosuppressive therapy including chronic steroids (except physiologic maintenance doses), methotrexate, or other known immunosuppressive agents
  • Pregnancy (assessed by urine HCG)
  • Breast feeding
  • Active pulmonary disease requiring medication to include multiple inhalers (>2 inhalers and one containing steroids)
  • Involved in other experimental protocols (except with permission of the other study PI)

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): NCT02678741


Locations
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United States, Alabama
University of Alabama Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35243
United States, California
John Wayne Cancer Institute/Providence Saint John's Health Center
Santa Monica, California, United States, 90404
United States, Florida
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
United States, Georgia
Northside Hospital
Atlanta, Georgia, United States, 30342
United States, Ohio
University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Washington
Providence Regional Medical Center
Everett, Washington, United States, 98201
Sponsors and Collaborators
Cancer Insight, LLC
Elios Therapeutics, LLC
Investigators
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Study Director: George Peoples, MD Cancer Insight, LLC

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Responsible Party: Cancer Insight, LLC
ClinicalTrials.gov Identifier: NCT02678741     History of Changes
Other Study ID Numbers: 20152397
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Vaccines
Immunologic Factors
Physiological Effects of Drugs