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

NCT00559026 | Completed Phase 1 DMC

• 2 other identifiers: ISS-DTIC-melvacc12007-006447-42
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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

Melanoma

Outcome Measures

Primary Outcomes (1)

• Assessment of safety by evaluating local and systemic adverse reactions during the trial. Assessment of the vaccine-specific cellular immune responses

  one year

Secondary Outcomes (1)

• Assessment of relapse-free survival and overall survival calculated from the time of the first chemotherapy/vaccine injection. Evaluation by microarray analysis of the gene expression profiles of patients PBMC 24 h after DTIC administration.

  two years

Study Arms (2)

1

ACTIVE COMPARATOR

Biological: Melan-A

2

EXPERIMENTAL

Other: Melan-A plus Dacarbazine

Interventions

Melan-A BIOLOGICAL

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

1

Melan-A plus Dacarbazine OTHER

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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically proven diagnosis of melanoma stage II, III, and IV without clinical/radiological evidence of disease
• Age \>18 years
• life expectancy of more than 6 months
• ECOG performance status of 0-2
• adequate blood cell counts and kidney-liver function
• use of adequate contraceptive methods
• signed informed consent

You may not qualify if:

• concomitant or previous history of malignant disease, except for in situ cervical carcinoma or non melanomatous skin cancer
• severe cardiovascular disease
• clinically active infections and/or significant autoimmune diseases
• concomitant or previous (within 6 weeks) treatment with immunosuppressive drugs
• previous treatments with chemotherapy and/or interferon alpha or beta within 4 weeks and/or radiotherapy within 6 weeks an/or biological therapy within 8 weeks before starting vaccination
• psychiatric illness interfering with patient compliance, pregnancy or lactation

Sponsors & Collaborators

• Istituto Superiore di Sanità: lead
• Regina Elena Cancer Institute: collaborator
• University of Rome Tor Vergata: collaborator

Study Sites (2)

University Hospital Tor Vergata

Rome, 00133, Italy

Location

Regina Elena Cancer Institute

Rome, 00153, Italy

Location

MeSH Terms

Conditions

Melanoma

Interventions

MART-1 Antigen; Dacarbazine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Melanoma-Specific Antigens; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens, Neoplasm; Antigens; Biological Factors; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Virginia Ferraresi, M.D.

  Regina Elena Cancer Institute

  PRINCIPAL INVESTIGATOR

• Mario Roselli, M.D.

  University of Rome Tor Vergata

  PRINCIPAL INVESTIGATOR

• Enrico Proietti, M.D.

  Istituto Superiore di Sanità

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 15, 2007
• First Posted: November 16, 2007
• Study Start: September 1, 2004
• Study Completion: September 1, 2006
• Last Updated: November 16, 2007

Record last verified: 2007-11

Locations

IT (2)