EUCTR2010-018638-29-BE
Active, not recruiting
Phase 1
Phase I/II study of peptide vaccination associated with GM-CT-01, a galactomannan oligomer that inhibits galestin-3, in patients with advanced metastatic melanoma - Peptide vaccinations plus GM-CT-01 in melanoma
Centre du Cancer des Cliniques Universitaires Saint-Luc0 sites6 target enrollmentSeptember 20, 2011
ConditionsMetastatic melanomaMedDRA version: 14.0Level: LLTClassification code 10025651Term: Malignant melanoma excisionSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA 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)MedDRA version: 14.0Level: PTClassification code 10025652Term: Malignant melanoma in situSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Metastatic melanoma
- Sponsor
- Centre du Cancer des Cliniques Universitaires Saint-Luc
- Enrollment
- 6
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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