MedTrace Logo

Phase I/II Study of Chemo-Immunotherapy Combination in Melanoma Patients

NCT00559026 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2007-11-16

No results posted yet for this study

Summary

This phase I/II study is directed at evaluating safety and immunogenicity of a melanoma peptide vaccine in combination or not with Dacarbazine administration in melanoma patients

Conditions

Interventions

BIOLOGICAL

Melan-A

i.d. injections of Melan-A: 26-35 (A27L) and gp100: 209-217 (210M) peptides (250 µg each) formulated in Montanide ISA-51 plus s.c. injection of 3MU IFN-α, as an adjuvant on day 1 and 8 every 21 days for a total of 5 courses

OTHER

Melan-A plus Dacarbazine

Dacarbazine plus vaccine: the vaccination schedule as in arm 1 was combined with DTIC (800 mg/mq i.v.) administered one day before each vaccine administration according to the standard treatment.

Sponsors & Collaborators

  • Regina Elena Cancer Institute

    collaborator OTHER

  • University of Rome Tor Vergata

    collaborator OTHER

  • Istituto Superiore di Sanità

    lead OTHER

Principal Investigators

  • Virginia Ferraresi, M.D. · Regina Elena Cancer Institute

  • Mario Roselli, M.D. · University of Rome Tor Vergata

  • Enrico Proietti, M.D. · Istituto Superiore di Sanità

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Completion
2006-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT00559026 on ClinicalTrials.gov