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A Study of Immunogenicity and Safety of Immunotherapy Plus Chemotherapy in Metastatic Melanoma Patients
This study is currently recruiting participants.
Verified by GlaxoSmithKline, August 2009
First Received: February 2, 2009   Last Updated: August 13, 2009   History of Changes
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00849875
  Purpose

The purpose of this clinical trial is to find out how successfully, patients with progressive metastatic cutaneous melanoma, are able to develop an immune response to injections with the immunotherapeutic product GSK1572932A when given in combination with dacarbazine and evaluate the safety of this combination.


Condition Intervention Phase
Malignant Melanoma
Neoplasms
Biological: Immunotherapeutic GSK2132231A
Drug: Dacarbazine
Phase I

Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Study of GSK2132231A Antigen-Specific Cancer Immunotherapeutic in Association With Chemotherapy in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of serious adverse events (SAEs) [ Time Frame: After the concluding visit of the last patient ] [ Designated as safety issue: No ]
  • Evaluation of immunogenicity [ Time Frame: At regular intervals during the treatment period (9 assessments per patient) and after the concluding visit of the last patient ] [ Designated as safety issue: No ]
  • The occurrence of treatment related adverse events of Grade 3 or 4 [ Time Frame: After the concluding visit of the last patient ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of any adverse events (including abnormal laboratory values for haematology and biochemistry) [ Time Frame: After the concluding visit of the last patient ] [ Designated as safety issue: No ]
  • The rate of objective response (complete and partial) [ Time Frame: After the concluding visit of the last patient ] [ Designated as safety issue: No ]
  • The rate of stable disease [ Time Frame: After the concluding visit of the last patient ] [ Designated as safety issue: No ]
  • The rate of mixed response [ Time Frame: After the concluding visit of the last patient ] [ Designated as safety issue: No ]
  • Time to study treatment failure [ Time Frame: After the concluding visit of the last patient ] [ Designated as safety issue: No ]
  • Progression free survival time [ Time Frame: After the concluding visit of the last patient ] [ Designated as safety issue: No ]
  • Progression free survival time after initial Slow Progressive Disease [ Time Frame: After the concluding visit of the last patient ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Group: Experimental
All patients are to receive the same treatment consisting of 24 injections of the immunotherapeutic GSK2132231A combined with a course of 8 cycles of dacarbazine given at the beginning of the treatment
Biological: Immunotherapeutic GSK2132231A
Intramuscular administration
Drug: Dacarbazine
Intravenous administration Chemotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patient with histologically proven, measurable metastatic cutaneous melanoma
  2. Written informed consent has been obtained from the patient before the performance of any protocol-specific procedure.
  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).
  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, 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 the 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 the requirements of the protocol.

Exclusion Criteria:

  1. The patient has at any time received systemic (bio)-chemotherapy.
  2. The patient is scheduled to receive any other anticancer treatments than those specified in the protocol, including but not limited to (bio)-chemotherapy, immunomodulating agents and radiotherapy.
  3. The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents.
  4. The patient received any cancer immunotherapeutic containing a MAGE-A3 antigen or any cancer immunotherapeutic for his/her metastatic disease.
  5. The patient has received any investigational or non-registered drug or vaccine other than the study medication within the 30 days preceding the first dose of study treatment, or plans to receive such a drug during the study period.
  6. The patient has (or has had) previous or concomitant malignancies at other sites, except effectively treated malignancy that is considered by the investigator highly likely to have been cured.
  7. History of allergic disease or reactions likely to be exacerbated by any component of the study investigational product.
  8. The patient has an autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
  9. The patient has a family history of congenital or hereditary immunodeficiency.
  10. The patient is known to be positive for the Human Immunodeficiency Virus (HIV).
  11. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the trial procedures.
  12. The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
  13. For female patients: the patient is pregnant or lactating.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00849875

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718

Locations
Belgium
GSK Investigational Site Recruiting
Brussels, Belgium, 1200
GSK Investigational Site Recruiting
Yvoir, Belgium, 5530
GSK Investigational Site Recruiting
Bruxelles, Belgium, 1180
France
GSK Investigational Site Recruiting
Paris Cedex 10, France, 75475
GSK Investigational Site Recruiting
Paris, France, 75018
GSK Investigational Site Not yet recruiting
Caen, France, 14033
GSK Investigational Site Recruiting
Villejuif, France, 94805
GSK Investigational Site Recruiting
Lille, France, 59037
GSK Investigational Site Recruiting
Nantes, France, 44093
GSK Investigational Site Recruiting
Reims, France, 51092
GSK Investigational Site Recruiting
Marseille, France, 13009
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: 111714
Study First Received: February 2, 2009
Last Updated: August 13, 2009
ClinicalTrials.gov Identifier: NCT00849875     History of Changes
Health Authority: Belgium: Agence Fédérale des Médicaments et des Produits de la Santé;   France: Agence Française de Sécurité Sanitaire des Produits de Santé

Keywords provided by GlaxoSmithKline:
Malignant melanoma
Cancer immunotherapeutic
ASCI
Dacarbazine
MAGE-A3

Study placed in the following topic categories:
Neuroectodermal Tumors
Dacarbazine
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Antineoplastic Agents, Alkylating
Nevus
Alkylating Agents
Melanoma, Familial
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Dacarbazine
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Pharmacologic Actions
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on August 30, 2009