Исследования / № 00796445
|Краткое название||A Phase III Study to Test the Benefit of a New Kind of Anti-cancer Treatment in Patients With Melanoma, After Surgical Removal of Their Tumor|
|Полное название||GSK 2132231A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resected Melanoma|
|Под контролем||United States: Food and Drug Administration|
|Краткое описание||The purpose of this clinical trial is to evaluate the benefit of the immunotherapeutic|
product GSK 2132231A in preventing disease relapse when given to melanoma patients, after
surgical removal of their tumor.
This Protocol Posting has been updated following Amendments 1 of the Protocol, March 2010.
The impacted sections are outcome measures and entry criteria.
|Дата начала||December 2008|
|Подробное описание||"http://www.immunotherapyforcancer.info provides information on the cancer immunotherapeutic|
approach in an easy-to-understand format" "http://www.ascitrials.com gives practical
information on the MAGRIT clinical study"
|Вид исследования||Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment|
- Written informed consent signed.
- Male or female patient with histologically proven stage IIIB or IIIC cutaneous
melanoma presenting with macroscopic lymph node involvement suitable for surgery.
- The patient must have been surgically rendered free of disease before the
- Patient is ?‰? 18 years old at the time of signing the informed consent form.
- The patient's lymph node tumor shows expression of the MAGE-A3 gene.
- The patient has fully recovered from surgery.
- ECOG performance status of 0 or 1 at the time of randomization.
- The patient must have adequate organ functions as assessed by standard laboratory
- If the patient is female, she must be of non-childbearing potential, or practice
- In the opinion of the investigator, the patient can and will comply with all the
requirements of the protocol.
- The patient suffers from a mucosal or ocular melanoma.
- The patient has or has had any history of in-transit metastases
- The patient has been treated or is scheduled to be treated with an adjuvant
anticancer therapy after the surgery that qualifies the patient for inclusion in the
- The patient requires concomitant chronic treatment with systemic corticosteroids or
any other immunosuppressive agents.
- Use of any investigational or non-registered product (drug or vaccine) other than the
- The patient has a history of autoimmune disease.
- The patient has a family history of congenital or hereditary immunodeficiency.
- The patient is known to be positive for Human Immunodeficiency Virus (HIV) or has
another confirmed or suspected immunosuppressive or immunodeficient condition.
- History of allergic disease or reactions likely to be exacerbated by any component of
- The patient has psychiatric or addictive disorders that may compromise his/her
ability to give informed consent or to comply with the trial procedures.
- 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
- The patient has previous or concomitant malignancies at other sites, except
effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or
effectively treated malignancy that has been in remission for over 5 years and is
highly likely to have been cured.
- The patient has an uncontrolled bleeding disorder.
- For female patients: the patient is pregnant or lactating.
|Минимальный возраст||18 Years|
|Контакты и расположение|
|Dnipropetrovsk , 49100||GSK Investigational Site|
|Dnipropetrovsk , 49102||GSK Investigational Site|
|Donetsk , 83092||GSK Investigational Site|
|Kryvyi Rih , 50048||GSK Investigational Site|
|Kyiv , 03022||GSK Investigational Site|
|Lviv , 79031||GSK Investigational Site|