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Peptide Vaccinations Plus GM-CT-01 in Melanoma

NCT01723813 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2019-03-12

No results posted yet for this study

Summary

The purpose of this study is to determine whether the intravenous and/or GM-CT-01 administration can correct Tumor Infiltrating Lymphocytes (TIL) anergy and induce a more efficient and long-lasting anti-tumoral immune response following peptide vaccination.

Conditions

Interventions

BIOLOGICAL

Tumor specific peptides: MAGE-3.A1 and / or NA17.A2

Each peptide will be given at a dose of 300 µg in 1 ml of sodium chloride 0.9%, every 3 weeks on 6 occasions, and will be administered at one site in arm or thigh, 20% of the dose intradermally and 80% of the dose subcutaneously.

BIOLOGICAL

Galectin-3 inhibitor: GM-CT-01 systemic injections

Systemic injection of GM-CT-01: GM-CT-01 will be administered by slow intravenous infusions at a dose of 280 mg/m2, on days +3, +6, +9, +12, +15, +18 after each of the 3rd, 4th, 5th and 6th vaccination.

BIOLOGICAL

Galectin-3 inhibitor: GM-CT-01 Peri-tumoral administration

GM-CT-01 will be injected peri-tumoral at a dose of 100 µg per tumor injected, on days +3, +6, +9, +12, +15, +18 after each of the 3rd, 4th, 5th and 6th vaccination. If a patient has one or two superficial metastases at day 43 of the treatment, one of these lesions will be treated. If a patient has more than two superficial metastases at day 43, two of these lesions will be treated.

Sponsors & Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    lead OTHER

Principal Investigators

  • Jean-Francois BAURAIN, MD, PhD · Cliniques univeristaires Saint-Luc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2015-04-01
Completion
2015-04-01

Countries

  • Belgium

Study Locations

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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 NCT01723813 on ClinicalTrials.gov