Abstract CT150: Initial analysis of open-label administration of autologous tumor lysate (TL) + dendritic cells (DC) vaccine (TLPLDC) in melanoma patients who recurred during a phase IIb adjuvant vaccine trial

2018 ◽  
Author(s):  
Tommy A. Brown ◽  
John W. Myers ◽  
Tim J. Vreeland ◽  
Diane F. Hale ◽  
Kaitlin M. Peace ◽  
...  
Keyword(s):  
Dendritic Cells ◽  
Vaccine Trial ◽  
Autologous Tumor ◽  
Tumor Lysate ◽  
Open Label ◽  
Initial Analysis ◽  
Dc Vaccine ◽  
Adjuvant Vaccine ◽  
Melanoma Patients

Induction of T cell precursors in advanced melanoma treated with autologous tumor lysate loaded dendritic cells

2004 ◽  
Vol 22 (14_suppl) ◽  
pp. 2623-2623
Author(s):  
T. S. Crocenzi ◽  
C. G. Tretter ◽  
J. Fisher ◽  
N. Crosby ◽  
D. Truman ◽  
...  
Keyword(s):  
Dendritic Cells ◽  
T Cell ◽  
Advanced Melanoma ◽  
Autologous Tumor ◽  
Tumor Lysate

A prospective, randomized, blinded, placebo-controlled, phase IIb trial of an autologous tumor lysate + 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.

2018 ◽  
Vol 36 (5_suppl) ◽  
pp. TPS201-TPS201 ◽  
Author(s):  
John W Myers ◽  
Garth S Herbert ◽  
Guy T Clifton ◽  
Timothy J Vreeland ◽  
Tommy A Brown ◽  
...  
Keyword(s):  
Cell Wall ◽  
Dendritic Cells ◽  
High Risk ◽  
Yeast Cell ◽  
Yeast Cell Wall ◽  
Stage Iii ◽  
Autologous Tumor ◽  
Tumor Lysate ◽  
Risk Of Recurrence ◽  
Disease Free

TPS201 Background: Melanoma is a potentially lethal skin malignancy; patients with stage III/IV resected disease have a recurrence rate of 50-90%. Adjuvant checkpoint inhibitor immunotherapy decreases the risk of recurrence but also causes significant immune-related toxicity. Vaccines are a promising strategy for patients with high risk melanoma. The optimal time to intervene may be in the adjuvant setting after attaining a disease-free state through standard of care therapies. Our strategy uses autologous tumor lysate (TL) in a yeast cell wall particle (YCWP) to load dendritic cells (DC) ex vivo. The tumor lysate particle loaded dendritic cell (TLPLDC) vaccine is then given to prevent melanoma recurrences. An alternate vaccine delivery method that we are evaluating utilizes the tumor lysate particle-only (TLPO) technique, in which tumor lysate is loaded into capped YCWP and injected intradermally, allowing an in vivo uptake by the patient’s dendritic cells. Methods: We are performing a prospective, randomized, blinded, placebo-controlled phase IIb trial in patients with resected stage III/IV melanoma who have been rendered disease-free but remain at high risk of recurrence. The study will utilize the TLPLDC strategy vs placebo (2:1) in 120 patients, followed by a bridging study of TLPO vs TLPLDC (2:1) in 60 patients. Both TLPLDC and TLPO inoculations will be monthly x3, followed by boosters at 6, 12, and 18 months. Primary endpoints will be disease free survival (DFS) at 24 months in the TLPLDC arm, and overall safety in the TLPO arm. We have completed enrollment in the phase IIb portion of the study. Clinical trial information: NCT02301611.

Immunological and clinical response after vaccination therapy of pancreatic carcinoma patients with autologous, tumor-lysate pulsed dendritic cells: Results of a phase II-study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4579-4579 ◽  
Author(s):  
C. Bauer ◽  
M. Dauer ◽  
S. Saraj ◽  
M. Schnurr ◽  
K. Jauch ◽  
...  
Keyword(s):  
Immune Response ◽  
Dendritic Cells ◽  
Pancreatic Carcinoma ◽  
Phase Ii Study ◽  
Immunological Response ◽  
Autologous Tumor ◽  
Adherent Cells ◽  
Tumor Lysate ◽  
Advanced Pancreatic Carcinoma ◽  
Vaccination Therapy

4579 Background: Multiple studies in the experimental and in the clinical setting have shown that vaccine therapy using dendritic cells can induce antitumor immunity. Here, we report about the results of a phase II-study using autologous, tumor-lysate pulsed dendritic cells for the treatment of patients with advanced pancreatic carcinoma. Methods: Pancreatic carcinoma patients receiving abdominal surgery were included into to the study protocol. Tumor-lysate was derived by freeze-taw-cycles from surgically derived tissue specimens. Patients were eligible for DC vaccination after recurrence of pancreatic carcinoma or in a primarily palliative situation. DC were derived from PBMC according to a six-day protocol, loaded with tumor lysate and stimulated with TNF-a and PgE2. DC were applicated intracutaneously into the groin region every other week for three cycles, then monthly. All patients received standard chemotherapy with gemcitabine concomitantly. Immune response was controlled by DTH skin testing. Samples of non adherent cells were frozen for MLR and ELISPOT assays to monitor immune response ex vivo. Main study end point was partial or complete remission. Results: Ten patients have received dendritic cell vaccination so far. Of these, one patient developed a partial remission after a four-months course of vaccination therapy. Another patient showed stable disease after having received five vaccinations. Both patients showed immunological response. The patient with stable disease had a mean of 56 IFN-γ positive spots per 50E3 DC-stimulated non adherent cells prior to vaccination. After vaccination, this number increased to 191 spots per 50E3 cells (negative control: 5; positive control: 315). Both patients are alive 13 and 7 months after the start of vaccination therapy, respectively. Conclusions: Vaccination therapy with dendritic cells can be of clinical benefit in the setting of advanced pancreatic carcinoma. Clinical responses were associated with the induction of a stable immunological response. No significant financial relationships to disclose.

Clinical efficacy of vaccination with the autologous tumor lysate particle loaded dendritic cell (TLPLDC) vaccine in metastatic melanoma.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e21025-e21025
Author(s):  
Annelies Hickerson ◽  
Guy T. Clifton ◽  
Tommy A Brown ◽  
Jessica Campf ◽  
John William Myers ◽  
...  
Keyword(s):  
Dendritic Cell ◽  
Metastatic Melanoma ◽  
Ex Vivo ◽  
Objective Response ◽  
Complete Response ◽  
Intradermal Injection ◽  
Autologous Tumor ◽  
Tumor Lysate ◽  
Open Label ◽  
Measurable Disease

e21025 Background: The treatment of melanoma has changed drastically with the advent of immunotherapy. The autologous tumor lysate, particle loaded, dendritic cell (TLPLDC) vaccine stimulates T-cells and may work synergistically with other immunotherapies. Here, we describe results in patients (pts) with metastatic melanoma (MM) treated with the TLPLDC vaccine together with other approved therapies. Methods: The TLPLDC vaccine is created using autologous tumor lysate loaded yeast cell wall particles to prime autologous dendritic cells ex-vivo. 1-1.5x106 TLPLDCs are given via intradermal injection monthly x 4 followed by boosters at six and nine months (mo). Pts who recurred while enrolled in our adjuvant phase IIb trial of the TLPLDC vaccine and pts with MM with measurable disease enrolled in a separate phase I/IIa trial were offered vaccination of TLPLDC vaccine in an open-label fashion in addition to other approved therapies as determined by their treating physician. Tumor response is measured by RECIST 1.1 criteria. Results: To date, 50 pts have been enrolled in the two trials (25 pts in each). Of the 42 pts with measureable disease, 30 pts received at least one dose of the vaccine, 11 progressed prior to vaccine administration, and 1 is pending. 2 pts withdrew at 2 and 7 mo. Of the remaining 28 evaluable pts, 13 pts had progressive disease with a median follow-up (f/u) of 3 (range 0-12) mo, 12 pts had stable disease with a median f/u of 7.5 (range 1-23) mo, 2 pts had a partial response with f/u of 7 and 13 mo, and one pt had a complete response with 18 mo of f/u. Overall, in pts with measureable disease, the disease control rate was 54% (15/28) and objective response rate was 11% (3/28). 8 pts were without measurable disease at enrollment, 3 recurred at a median f/u of 8 mo and 5 remain disease-free at a median of 26 mo f/u. No grade ≥ 3 toxicities were observed with combination TLPLDC vaccination and approved systemic therapies. Conclusions: Vaccination with the TLPLDC vaccine in combination with systemic approved therapies in MM pts is well tolerated and may provide clinical benefit in patients with and without measurable disease. Clinical trial information: NCT02678741.

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