CCR5-blockade in Metastatic Colorectal Cancer (MARACON)
|ClinicalTrials.gov Identifier: NCT01736813|
Recruitment Status : Completed
First Posted : November 29, 2012
Last Update Posted : March 22, 2017
|Condition or disease||Intervention/treatment|
|Colorectal Cancer Neoplasm Metastasis Liver Metastases||Drug: Maraviroc|
|Study Type :||Observational|
|Actual Enrollment :||12 participants|
|Official Title:||Treatment of Advanced Colorectal Cancer Patients With Hepatic Liver Metastases Using the CCR5-Antagonist Maraviroc (Phase I Maracon Trial)|
|Study Start Date :||November 2012|
|Primary Completion Date :||December 2013|
|Study Completion Date :||September 2014|
CCR5-inhibitor at 300 mg/bid
colorectal cancer patients with liver metastases (twelve patients treated with 300 mg/bid)
Twelve patients with 300 mg/bid
Other Name: Celsentri
- safety as occurence of adverse events ≥ Grade 3 according to CTCAE, Version 4.0 criteria, that are definitely, probably, or possible related to the administration of the investigational agent [ Time Frame: after eight weeks of treatment ]safety, tolerability and feasibility will be assessed after eight weeks of continuous intake of the CCR5-inhibitor. Safety measures include blood analyses (hematologic, liver function, renal function etc.) and the overall performance status of the patient. Especially infections and infection-related events are investigated.
- Progression Free Survival [ Time Frame: one year after eight weeks of treatment ]Patients will be evaluated for one year afterwards to assess progression free survival.
- Tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: after eight weeks of treatment ]Tumor response will be evaluated after eight weeks of continuous treatment with the CCR5-inhibitor, using the RECIST criteria on MRI images (comparing pre- and post-treatment)
- Tissue level responses of growth inhibition via the CCR5 axis [ Time Frame: during the first four weeks of treatment ]The evaluation of tissue alterations within the tumor microenvironment induced by CCR5-inhibition will be performed during the first four weeks of treatment, comparing the pre-treatment tissue situation with the post-treatment situation.
- Overall survival [ Time Frame: one year after eight weeks of treatment ]Patients will be evaluated for one year afterwards to assess overall survival.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01736813
|National Center for Tumor Diseases, Department of Medical Oncology|
|Heidelberg, Baden-Württemberg, Germany, 69120|
|Principal Investigator:||Niels Halama, MD||National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Heidelberg, Germany|
|Study Director:||Dirk Jaeger, MD||National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Germany|