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Trial record 95 of 228 for:    yeast

Phase IIB TL + YCWP + DC in Melanoma

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ClinicalTrials.gov Identifier: NCT02301611
Recruitment Status : Active, not recruiting
First Posted : November 26, 2014
Last Update Posted : August 8, 2019
Sponsor:
Collaborator:
Elios Therapeutics, LLC
Information provided by (Responsible Party):
Cancer Insight, LLC

Brief Summary:
The majority of melanoma vaccines tested to date have been antigen-specific vaccines targeting melanoma-specific or associated antigens and utilizing a variety of delivery systems and immune-adjuvants. As opposed to testing an "off the shelf" vaccine that might be able to treat a subset of patients, our approach has been personalized to the patient and applicable to all patients. Our vaccine approach consists of harnessing the most potent antigen presenting cell in the body - the dendritic cell (DC) - together with the full repertoire of tumor antigens from an individual's cancer. We have conducted phase I and II studies using an autologous DC-tumor cell fusion technique that has now been simplified into a DC-tumor cell lysate vaccine. The autologous tumor lysate (TL) is loaded into yeast cell wall particles (YCWP) that are naturally and efficiently taken up into the patient's DC. These autologous tumor lysate, particle-loaded, DC (TLPLDC) are injected intradermally (ID) monthly x 3 followed by boosters at 6, 12, and 18 months.

Condition or disease Intervention/treatment Phase
Melanoma Drug: TLPLDC Drug: Placebo Phase 2

Detailed Description:

Stage III and Stage IV (resected) melanoma patients will be identified prior to definitive surgery and screened for inclusion/exclusion criteria. Eligible patients will be counseled and consented for tissue procurement. Enrolled patients will have their disease surgically resected and a portion 1mg minimum of their melanoma sterilely frozen in provided freezing vials and storage tubes. This tissue will be shipped in liquid nitrogen shippers through FedEx to our central facility in Greenville SC and stored frozen until vaccine preparation. If patients cannot be rendered disease-free, they will be considered screen failures for this study. If melanoma is being resected from multiple locations primary and nodes two different metastatic sites then samples of each would be preferred but not mandatory.

As indicated by SoC per the National Comprehensive Cancer Network (NCCN) guidelines and determined by the treating team, if a patient is to receive systemic therapy (chemotherapy or IFN-aguidelines) and determined by the treating team, if a patient is to receive systemic therapy (chemotherapy or IFN-central facility in Greenville, SC) and stored frozen until vaccine preparation. If patients cannot be rendered disease-free, they will receive a single injection of Neupogen (G-CSF) 300 mod (or its equivalent) SQ 24-48 hrs. prior to having 70 mL of blood collected and sent to our central facility for DC isolation and preparation. Patients who cannot tolerate Neupogen, or its equivalent 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 1-1.5 x 106 TLPLDC and will be labeled with the patient's unique study number.

Based on their randomization, autologous TLPLDC (active vaccine) or unloaded YCWP + autologous DC (control) will be sent back to the site in a blinded fashion. Regardless of assigned group, the site will receive 6 single dose vials to be injected intradermal monthly x 3 followed by boosters at 6, 12, and 18 months in the same lymph node draining area (preferably the anterior thigh). Patients must begin vaccinations between 3 weeks and 3 months from completion of (SoC). Frozen tumor will be maintained for active vaccines for all patients to include the control patients. The latter will be offered their active vaccine at time of recurrence in a crossover fashion. Additionally, control patients who do not recur will be offered active vaccine at the completion of the trial.

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.

Disease-free status will be monitored per SoC as outlined by NCCN. Suspected recurrences will be documented with biopsy and pathologic confirmation. Time to recurrence will be based on date of randomization to time of confirmed recurrence.

Recurrent patients will be offered participation in the open label portion of the study. New active vaccine will be made for all patients, and they will be inoculated at 0, 1, 2, 3, 6, and 9 mos. Patients will be treated per SoC for their recurrence. Safety and tumor response will be assessed per RECIST and irRC on their SoC follow-up scans.

Blood (50 mL) will be collected from all patients prior to each inoculation and at 24 months from enrollment for a total of 7 time points or a total of 350 mL of blood over 2 years. The collected blood will be sent to our central facility for immunologic testing of the T-cell response.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Blinded, Placebo-controlled, Phase IIb Trial of an Autologous Tumor Lysate (TL) + Yeast Cell Wall Particles (YCWP) + Dendritic Cells (DC) Vaccine vs Unloaded YCWP + DC and Embedded Phase I/IIa Trial With Tumor Lysate Particle Only (TLPO) Vaccine in Stage III and Stage IV (Resected) Melanoma to Prevent Recurrence.
Study Start Date : January 2015
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Treatment
autologous TLPLDC (active vaccine)
Drug: TLPLDC
Autologous tumor lysate, particle-loaded dendritic cell vaccine

Placebo Comparator: Placebo
unloaded YCWP + autologous DC (control)
Drug: Placebo



Primary Outcome Measures :
  1. Disease Free Survival Assessment [ Time Frame: 24 months ]
    The primary outcome measure of the trial is assessing disease free survival (DFS) at 24 months compared between the vaccinated and control groups after the final enrolled patient completes two years of follow-up. An interim analysis will be performed six months after the final patient is enrolled. This analysis will compare median DFS between vaccinated and control groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (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 0,1 (Appendix D)
  • AJCC stage III or IV completely resectable melanoma identified before surgery
  • Approximately 1 mg (1 cm3) of accessible and dispensable tumor that will not interfere with pathologic staging
  • Clinically disease-free after surgery
  • Completing SoC adjuvant therapy per NCCN guidelines to include chemotherapy, radiation therapy, and/or biologic therapy as clinically indicated. (Consent #2 should be signed as close to completion of SoC as possible but may overlap completion by up to one month.)
  • Vaccinations initiated between 3 weeks and 3 months from completion of SoC multi-modality cancer care
  • 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%
  • 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)
  • Signed informed consent

Exclusion Criteria:

  • Evidence of residual disease after surgery and SoC adjuvant therapies
  • Insufficient tumor available to produce vaccine
  • ECOG >2 performance status (Appendix D)
  • Immune deficiency disease or known history of HIV, HBV, HCV
  • Receiving immunosuppressive therapy including chronic steroids, 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): NCT02301611


Locations
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United States, Alabama
University of Alabama Birmingham (UAB) Comprehensive Cancer Center
Birmingham, Alabama, United States, 35243
United States, Arizona
Mayo Clinic - Cancer Clinical Research Office
Phoenix, Arizona, United States, 85054
The University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
The Angeles Clinic and Research Institute A Cedars-Sinai Affiliate
Los Angeles, California, United States, 90025
John Wayne Cancer Institute
Santa Monica, California, United States, 90404
United States, Florida
Mount Sinai Cancer Research Program
Miami Beach, Florida, United States, 33140
United States, Georgia
Northside Hospital Cancer Institute
Atlanta, Georgia, United States, 30341
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Indiana
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
United States, Minnesota
Mayo Clinic, Rochester
Rochester, Minnesota, United States, 55905
United States, New Mexico
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, United States, 87102
United States, New York
Laura and Isaac Permutter Cancer Center @ NYU Langone
New York, New York, United States, 10016
United States, Ohio
University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States, 45267
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43202
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
St. Francis Hospital Cancer Center
Greenville, South Carolina, United States, 29607
United States, Utah
Huntsman Cancer Institute/The University of Utah
Salt Lake City, Utah, United States, 84112
United States, Washington
Providence Regional Medical Center Everett
Everett, Washington, United States, 98201
Sponsors and Collaborators
Cancer Insight, LLC
Elios Therapeutics, LLC
Investigators
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Study Director: George E Peoples, MD Cancer Insight, LLC

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Responsible Party: Cancer Insight, LLC
ClinicalTrials.gov Identifier: NCT02301611     History of Changes
Other Study ID Numbers: WIRB Protocol: 20141932
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: August 8, 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