A Study of Safety and Clinical Activity of Immunotherapy Plus Chemotherapy in Metastatic Melanoma Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00849875
First received: February 2, 2009
Last updated: September 18, 2014
Last verified: September 2014
  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
Melanoma
Biological: Immunotherapeutic GSK2132231A
Drug: Dacarbazine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:
  • 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 ]
  • Occurrence of serious adverse events (SAEs) [ Time Frame: After the concluding visit/contact 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 ]

Secondary Outcome Measures:
  • 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/contact of the last patient ] [ Designated as safety issue: No ]
  • The rate of mixed response [ Time Frame: After the concluding visit/contact of the last patient ] [ Designated as safety issue: No ]
  • Time to study treatment failure [ Time Frame: After the concluding visit/contact of the last patient ] [ Designated as safety issue: No ]
  • Progression free survival time [ Time Frame: After the concluding visit/contact of the last patient ] [ Designated as safety issue: No ]
  • Progression free survival time after initial Slow Progressive Disease [ Time Frame: After the concluding visit/contact of the last patient ] [ Designated as safety issue: No ]
  • 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 ]
  • Overall survival [ Time Frame: After the concluding visit / contact of the last patient ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: May 2009
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
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
Other Names:
  • DTIC
  • Imidazole Carboxamide
  • DTIC-Dome

Detailed Description:

This Protocol Posting has been updated following amendment 3, dated 16 October 2009. The sections impacted are :

  • Enrollment, number of subjects
  • Outcome measures
  • Exclusion criteria
  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.
  14. The patient has an uncontrolled bleeding disorder.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849875

Locations
Belgium
GSK Investigational Site
Brussels, Belgium, 1200
GSK Investigational Site
Bruxelles, Belgium, 1180
GSK Investigational Site
Jette, Belgium, 1090
GSK Investigational Site
Liège, Belgium, 4000
GSK Investigational Site
Roeselare, Belgium, 8800
GSK Investigational Site
Yvoir, Belgium, 5530
France
GSK Investigational Site
Caen, France, 14033
GSK Investigational Site
Lille, France, 59037
GSK Investigational Site
Marseille Cedex 5, France, 13385
GSK Investigational Site
Nantes, France, 44093
GSK Investigational Site
Paris, France, 75018
GSK Investigational Site
Paris Cedex 10, France, 75475
GSK Investigational Site
Reims, France, 51092
GSK Investigational Site
Villejuif, France, 94805
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00849875     History of Changes
Other Study ID Numbers: 111714
Study First Received: February 2, 2009
Last Updated: September 18, 2014
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:
ASCI
Dacarbazine
Cancer immunotherapeutic
MAGE-A3
Malignant melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 01, 2014