An open Phase I/II study of immunization with the recMAGE-A3 + AS15 Antigen Specific Cancer Immunotherapeutic in association with dacarbazine in patients with MAGE-A3 positive unresectable and progressive metastatic cutaneous melanoma - MAGE3-AS15-MEL-002 (MET-chemo)

GlaxoSmithKline Biologicals0 sites40 target enrollmentDecember 11, 2008

ConditionsPatients with unresectable and progressive metastatic cutaneous melanoma, whose tumor expresses MAGE-A3.MedDRA version: 16.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with unresectable and progressive metastatic cutaneous melanoma, whose tumor expresses MAGE-A3.
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 40
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 11, 2008

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Biologicals

Eligibility Criteria

Inclusion Criteria

•1\. Male or female patient with histologically proven, measurable metastatic cutaneous melanoma.
•According to the American Joint Committee on Cancer 2002 classification, all melanoma patients with stage IV M1b and stage IV M1c with serum lactate dehydrogenase (LDH) \<\= 1\.5 Upper Normal Limit and no involvement of the central nervous system (CNS) are candidates for inclusion.
•2\. Written informed consent has been obtained from the patient before the performance of any protocol\-specific procedure. Note: Procedures performed before obtaining this informed consent and that are part of standard institution practices or of another clinical research study are accepted provided protocol intervals are observed.
•3\. Patient is \>\= 18 years of age at the time of signature of the Informed Consent.
•4\. The patient’s tumor shows expression of MAGE\-A3 antigen, detected by Reverse\-Transcription Polymerase Chain Reaction (RT\-PCR). A tumor biopsy performed in the context of institution standard practice or another research study may be used for the MAGE\-A3 testing (or the use of the result of the MAGE\-A3 testing) provided this biopsy was preserved in RNAlater, was taken no more than 12 weeks before the first administration of study treatment and after obtention of the Sponsor’s agreement.
•5\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\.
•6\. The patient has normal organ functions
•7\. If the patient is female, she must be of non\-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post\-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to administration of study treatment, have a negative pregnancy test and continue such precautions during all study treatment period and for 2 months after completion of the treatment administration series.
•8\. In the view of the investigator, the patient can and will comply with all the study procedures
•Are the trial subjects under 18? no

Exclusion Criteria

•1\. The patient has at any time received systemic (bio\-)chemotherapy (except for
•isolated limb perfusion, as long as this was performed at least 4 weeks before the
•first study treatment administration).
•2\. The patient is scheduled to receive any other anticancer treatments than those
•specified in the protocol, including but not limited to (bio\-)chemotherapeutic,
•immunomodulating agents and radiotherapy.
•3\. The patient requires concomitant treatment with systemic corticosteroids, or any
•other immunosuppressive agents.
•The use of prednisone, or equivalent, \< 0\.125 mg/kg/day (absolute maximum
•10 mg/day), or inhaled corticosteroids for chronic obstructive pulmonary disease