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Complementary Vaccination With Dendritic Cells Pulsed With Autologous Tumor Lysate in Resected Stage III and IV Melanoma Patients.

NCT02718391 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-04-22

No results posted yet for this study

Summary

This phase II, randomized, open-label trial aims to assess whether the vaccination increase RFS in disease free melanoma patients after surgery. Patients will be randomized between Intradermal Autologous Dendritic Cell Vaccine loaded with autologous tumor lysate or homogenate (6 vaccines every 4 weeks) and observation.

Conditions

  • Malignant Melanoma
  • Adjuvant Drug Therapy
  • Vaccin Therapy

Interventions

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.

Sponsors & Collaborators

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

    lead OTHER

Principal Investigators

  • Laura Ridolfi, MD · IRST IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2019-11-30
Completion
2019-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02718391 on ClinicalTrials.gov