The surface molecule CCR5 is found on tumor cells within liver metastases of colorectal cancer. Inhibition of this molecule leads to a reduction in growth signals for tumor cells and subsequent slowed or halted tumor growth. The agent for the inhibition of CCR5 has already received FDA approval for treatment of HIV and has shown little side effects and toxicities even on long term treatment. Therefore CCR5-inhibition has the potential of providing non-toxic tumor growth inhibition.
Study Type
OBSERVATIONAL
Enrollment
12
Twelve patients with 300 mg/bid
National Center for Tumor Diseases, Department of Medical Oncology
Heidelberg, Baden-Wurttemberg, Germany
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
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.
Time frame: after eight weeks of treatment
Progression Free Survival
Patients will be evaluated for one year afterwards to assess progression free survival.
Time frame: one year after eight weeks of treatment
Tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST)
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)
Time frame: after eight weeks of treatment
Tissue level responses of growth inhibition via the CCR5 axis
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.
Time frame: during the first four weeks of treatment
Overall survival
Patients will be evaluated for one year afterwards to assess overall survival.
Time frame: one year after eight weeks of treatment
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