Complementary Vaccination With Dendritic Cells Pulsed With Autologous Tumor Lysate in Resected Stage III and IV Melanoma Patients. (ACDC)
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|ClinicalTrials.gov Identifier: NCT02718391|
Recruitment Status : Terminated (The randomization to the observational arm of the trial was no longer ethical)
First Posted : March 24, 2016
Last Update Posted : April 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Malignant Melanoma Adjuvant Drug Therapy Vaccin Therapy||Biological: Autologous Dendritic Cell vaccine||Phase 2|
This study will be a randomized phase II trial (1:1 allocation ratio) in resected stage III/IV melanoma patients. The randomization list will be stratified by stage (III and IV M1a-b and IVM1c), and time from primitive tumor to first metastasis (≤ 2 years versus > 2 years). Five randomization lists will be defined, one for each stratum.
On the basis of literature, the investigators assume a median relapse-free survival of 7.0 months for the standard group. With a two-sided tailed alpha of 0.10 and power of 80%, assuming a median relapse-free survival of 11.7 months in the experimental arm (hazard ratio 0.60), it will be necessary to recruit 60 patients per arm over a period of 24 months and to have a subsequent 12 months of follow-up. In the context of data monitoring board activities, an interim analysis for futility, according to the Bayesian approach, will be performed at 18 months in order to control the safety.
Primary endpoints will be relapse free survival. Secondary end points will be OS, In vivo and in vitro immunomonitoring. Immunologic efficacy will be measured by best Delayed Type Hypersensitivity score (reactivity to lysate or KLH) obtained after at least 4 vaccine doses, alone or combined with Interferon-g ELISPOT analysis of tumor antigen-specific circulating effectors obtained after a minimum of 4 vaccine doses, both compared with prevaccine samples. In vivo monitoring will focus on functional phenotyping of circulating immune effectors/regulators, functional characterization of circulating tumor antigen-specific immune effectors and regulators, and identification of serum markers that are predictive of response.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Complementary Vaccination With Dendritic Cells Pulsed With Autologous Tumor Lysate in Resected Stage III and IV Melanoma Patients: a Phase II Randomized Trial (ACDC Adjuvant Trial)|
|Actual Study Start Date :||August 2015|
|Actual Primary Completion Date :||November 2019|
|Actual Study Completion Date :||November 2019|
Experimental: Arm A: Autologous Dendritic Cell vaccine
Daily 3 MU Interleukin 2 will be administered subcutaneously for 5 days starting from the second day after each vaccine dose. Vaccine doses will be given intradermally in two sites close to inguinal or axillary lymphnode stations that had not site of previous surgical exeresis.The first dose (WK1) will consist of freshly prepared vaccine, whereas for all the further doses cryopreserved aliquots will be utilized. The remaining 5 doses will be administered every 4 weeks to complete six months of therapy (six vaccines).
Biological: Autologous Dendritic Cell vaccine
The Dendritic Cells vaccine is given intradermally with 5 injections in sites close to inguinal or axillary lymphnode stations that had not site of previous surgical exeresis; as a rule, vaccine administrations should be performed by alternating injections sites. Two days after each vaccine administration, daily 3 MU Interleukin 2 will be administered subcutaneously for 5 days.
No Intervention: Arm B: follow up
Arm B: Patients will undergo laboratory and clinical assessment, tumor re-staging, blood collection for immunological biomarkers every 12 weeks until relapse.
- Relapse-free survival (RFS) [ Time Frame: The time from the date of randomization to the date of the first relapse or the date of death from any cause or the date of the last restaging in non relapsed patients, assessed up to 36 months ]
- Overall survival (OS) [ Time Frame: From the date of randomization until the date of death from any cause or the last date the patient was known to be alive, assessed up to 36 months ]
- Immunologic efficacy will be measured by best delayed-type hypersensitivity score (reactivity to lysate or KLH) obtained after at least 4 vaccine doses [ Time Frame: up to 36 months ]
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): NCT02718391
|UO Oncologia Medica, IRCCS IRST|
|Meldola (FC), FC, Italy, 47014|
|UO Immunoterapia e laboratorio TCS, IRST IRCCS|
|Meldola, FC, Italy, 47014|
|Principal Investigator:||Laura Ridolfi, MD||IRST IRCCS|