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.

Status: complete

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.

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)

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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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.

Description

Eligibility Criteria

Locations & Contacts

Trial Objectives and Outline

Trial Phase & Type

Lead Organization

Trial IDs

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