CCR5-blockade in Metastatic Colorectal Cancer (MARACON)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual Primary Completion Date :||December 2013|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|