Phase IIB TL + YCWP + DC in Melanoma
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|ClinicalTrials.gov Identifier: NCT02301611|
Recruitment Status : Completed
First Posted : November 26, 2014
Last Update Posted : September 19, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: TLPLDC Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||184 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Actual Primary Completion Date :||May 11, 2022|
|Actual Study Completion Date :||May 11, 2022|
autologous TLPLDC (active vaccine)
Autologous tumor lysate, particle-loaded dendritic cell vaccine
Placebo Comparator: Placebo
unloaded YCWP + autologous DC (control)
- 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.
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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|
- 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
- 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)
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
|Study Director:||George E Peoples, MD||LumaBridge|
|Responsible Party:||Cancer Insight, LLC|
|Other Study ID Numbers:||
|First Posted:||November 26, 2014 Key Record Dates|
|Last Update Posted:||September 19, 2022|
|Last Verified:||September 2022|
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas