Anti-tumoral vaccination of melanoma patients with peptides associated with GM-CT-01, a vegetal derived sugar that binds to and blocks galectin, a protein produced by tumor cells that inhibits immune cells.

Phase 1

• Conditions: Metastatic melanoma; MedDRA version: 14.0Level: LLTClassification code 10025651Term: Malignant melanoma excisionSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.0Level: LLTClassification code 10027150Term: Melanoma malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0Level: PTClassification code 10042550Term: Superficial spreading melanoma stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0Level: LLTClassification code 10029488Term: Nodular melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0Level: LLTClassification code 10025662Term: Malignant melanoma of skin of scalp and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0Level: LLTClassification code 10040891Term: Skin melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0Level: LLTClassification code 10056768Term: Malignant melanoma of skin of lower limb, incl hipSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0Level: LLTClassification code 10048434Term: Melanoma malignant aggravatedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0Level: LLTClassification code 10042548Term: Superficial spreading melanoma in situSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2010-018638-29-BE
• Lead Sponsor: Centre du Cancer des Cliniques Universitaires Saint-Luc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-20
• Study Completion: 2016-03-01
• Last Update Posted: 28 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1. Patients with histologically proven cutaneous melanoma at one of the following AJCC stages:

- Regional metastatic disease (any T; N2c or N3; M0), not amenable to curative treatment by surgery or isolated limb perfusion.
- Distant metastatic disease (any T; any N; M1a, M1b or M1c*).
*except uncontrolled brain metastasis and except LDH >1,5ULN

2. HLA-A1 or HLA-A2 (by serology or molecular biology).

3. At least one of the two following conditions:
MAGE-3 gene expression by the tumor if patient is HLA-A1
NA17 gene expression by the tumor if patient is HLA-A2 (determined by RT-PCR analysis).

4. Measurable Disease.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 31
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1. Uncontrolled brain or central nervous system metastasis.

2. Previous treatment for the melanoma within 6 weeks from inclusion, with any reagent known to modulate the immune system such as a cancer vaccine, interferon-alpha, interleukins or anti-CTLA-4 antibodies.

3. Previous chemotherapy, radiotherapy, corticotherapy, or other immune suppressive therapy within 4 weeks from inclusion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified