Colorectal CancerMARACONNCT01736813
CCR5-blockade in Metastatic Colorectal Cancer
An observational study of Colorectal Cancer and Neoplasm Metastasis, run by National Center for Tumor Diseases, Heidelberg at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Neoplasm Metastasis, Liver Metastases
- What is being tested?
- Maraviroc
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2012to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: large university hospital with local private practice referrers
Who may be able to join
- written informed consent (must be available before enrollment in the trial)
- age ≥ 18 years
- male or female patient with a history of treated metastatic stage IV colorectal cancer with liver metastases of the primary colorectal cancer
- histologically confirmed liver metastasis of colorectal cancer with histologically confirmed CCR5 (C-C chemokine receptor type 5) expression in the tumor cells
- expected survival of at least three months
- Karnofsky performance status > 70 %
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- patients that have received current standard treatment options (progression or intolerance to oxaliplatin, irinotecan and 5-Fluorouracil with or without treatment combinations of cetuximab and/or bevacizumab or panitumumab)
- no chemotherapy treatment within the last three weeks
- within the last 2 weeks prior to study day 1 the following laboratory parameters, which should be within the ranges specified (or as deemed acceptable by trial investigator): absolute neutrophil count (ANC) ≥ 1000/mm3 (≥ 1.0 x 109/L), platelets ≥ 80.000/mm3 (≥ 80 x 109/L), creatinine Clearance limit as assessed by glomerular filtration rate > 60 mL/min/1.73m², ALT (alanine transaminase), AST (aspartate transaminase), and total bilirubin all ≤ 5.0 x ULN (upper limit normal)
- able and willing to give valid written informed consent and to understand character and individual consequences of the clinical trial
- if the patient is female, she must be of non-childbearing potential, or practice adequate contraception.
Who cannot join
- Patients with severe kidney disorders (GFR of <30 mL/min/1.73m² and diagnosed kidney disease) or who are on hemodialysis. The patient requires concomitant chronic treatment with systemic corticosteroids or any other immunosuppressive agents. Topical or inhalational steroids are permitted.
- Patients taking immunomodulatory medication (Type 1 interferons).
- Use of any investigational or non-registered product (drug or vaccine) other than the study treatment
- Patients with single metastatic lesions (intent to resect the metastasis)
- Patients with metastatic colorectal cancer that have a drastic clinical progression (e.g. from Karnofsky performance 100% to 60%) within the last six weeks before screening cannot participate
- The patient has a history of autoimmune disease.
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- The patient has a family history of congenital or hereditary immunodeficiency.
- The patient is known to be positive for Human Immunodeficiency Virus (HIV) or other chronic infections (HBV, HCV).or has another confirmed or suspected immunosuppressive or immunodeficient condition.
- 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 chronic severe medical problems (heart failure, uncontrolled diabetes, bleeding disorder etc.), unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
- The patient has previous or concomitant malignancies at other sites, except effectively treated 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.
- For female patients: the patient is pregnant or lactating.
- Women of childbearing potential: Refusal or inability to use effective means of contraception
- History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
- Participation in other clinical trials or observation period of competing trials, respectively
- No subject will be allowed to enroll in this trial more than once.
Trial locations and contacts
1 site in 1 country.
Germany1 site
National Center for Tumor Diseases, Department of Medical Oncology
Heidelberg, Baden-Wurttemberg, 69120
About this study
Official title: Treatment of Advanced Colorectal Cancer Patients With Hepatic Liver Metastases Using the CCR5-Antagonist Maraviroc (Phase I Maracon Trial)
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.
- Conditions
- Colorectal Cancer, Neoplasm Metastasis, Liver Metastases
- Being tested
- Maraviroc
- Keywords
- colorectal cancer, liver metastases, chemotherapy, chemokine, CCR5 inhibition
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaravirocDrug
Also called Celsentri
Twelve patients with 300 mg/bid
| Study group | Role | What they receive |
|---|---|---|
| CCR5-inhibitor at 300 mg/bid | colorectal cancer patients with liver metastases (twelve patients treated with 300 mg/bid) Receives: Drug: Maraviroc |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after eight weeks of treatment
Secondary outcomes (4)
Progression Free Survival
Patients will be evaluated for one year afterwards to assess progression free survival.
Measured: 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)
Measured: 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.
Measured: during the first four weeks of treatment
Overall survival
Patients will be evaluated for one year afterwards to assess overall survival.
Measured: one year after eight weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Tumor Diseases, Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Heidelberg
- Responsible party
- Sponsor
- Investigators
- Niels Halama, MD, Principal investigator, National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Heidelberg, GermanyDirk Jaeger, MD, Study director, National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736813
- Sponsor's protocol ID
- MARACON-001
- Other IDs
- 2012-000861-18
- Acronym
- MARACON
- Status last verified
- Jul 2014
- First submitted
- 24 Oct 2012
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Halama N, Zoernig I, Berthel A, Kahlert C, Klupp F, Suarez-Carmona M, Suetterlin T, Brand K, Krauss J, Lasitschka F, Lerchl T, Luckner-Minden C, Ulrich A, Koch M, Weitz J, Schneider M, Buechler MW, Zitvogel L, Herrmann T, Benner A, Kunz C, Luecke S, Springfeld C, Grabe N, Falk CS, Jaeger D. Tumoral Immune Cell Exploitation in Colorectal Cancer Metastases Can Be Targeted Effectively by Anti-CCR5 Therapy in Cancer Patients. Cancer Cell. 2016 Apr 11;29(4):587-601. doi: 10.1016/j.ccell.2016.03.005.
PubMed 27070705
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Advanced Colorectal Cancer Patients With Hepatic Liver Metastases Using the CCR5-Antagonist Maraviroc (Phase I Maracon Trial)
- ClinicalTrials.gov ID
- NCT01736813
- Acronym / sponsor ID
- MARACON / MARACON-001
- Conditions
- Colorectal Cancer, Neoplasm Metastasis, Liver Metastases
- Keywords
- colorectal cancer, liver metastases, chemotherapy, chemokine, CCR5 inhibition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National Center for Tumor Diseases, HeidelbergUniversity, hospital or other
- Collaborators
- University Hospital Heidelberg
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CCR5-inhibitor at 300 mg/bid | – | Drug: Maraviroccolorectal cancer patients with liver metastases (twelve patients treated with 300 mg/bid) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- large university hospital with local private practice referrers
Key inclusion criteria (11 listed)
- written informed consent (must be available before enrollment in the trial)
- age ≥ 18 years
- male or female patient with a history of treated metastatic stage IV colorectal cancer with liver metastases of the primary colorectal cancer
- histologically confirmed liver metastasis of colorectal cancer with histologically confirmed CCR5 (C-C chemokine receptor type 5) expression in the tumor cells
- expected survival of at least three months
Key exclusion criteria (16 listed)
- Patients with severe kidney disorders (GFR of <30 mL/min/1.73m² and diagnosed kidney disease) or who are on hemodialysis. The patient requires concomitant chronic treatment with systemic corticosteroids or any other immunosuppressive agents. Topical or inhalational steroids are permitted.
- Patients taking immunomodulatory medication (Type 1 interferons).
- Use of any investigational or non-registered product (drug or vaccine) other than the study treatment
- Patients with single metastatic lesions (intent to resect the metastasis)
- Patients with metastatic colorectal cancer that have a drastic clinical progression (e.g. from Karnofsky performance 100% to 60%) within the last six weeks before screening cannot participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MaravirocAlso: CelsentriTwelve patients with 300 mg/bid | Drug | CCR5-inhibitor at 300 mg/bid |
Primary outcome
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.
4 secondary outcomes
Progression Free Survival
Time frame: one year after eight weeks of treatment
Tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: after eight weeks of treatment
Tissue level responses of growth inhibition via the CCR5 axis
Time frame: during the first four weeks of treatment
Overall survival
Time frame: one year after eight weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- Results publication: PubMed 27070705Halama N, Zoernig I, Berthel A, Kahlert C, Klupp F, Suarez-Carmona M, Suetterlin T, Brand K, Krauss J, Lasitschka F, Lerchl T, Luckner-Minden C, Ulrich A, Koch M, Weitz J, Schneider M, Buechler MW, Zitvogel L, Herrmann T, Benner A, Kunz C, Luecke S, Springfeld C, Grabe N, Falk CS, Jaeger D. Tumoral Immune Cell Exploitation in Colorectal Cancer Metastases Can Be Targeted Effectively by Anti-CCR5 Therapy in Cancer Patients. Cancer Cell. 2016 Apr 11;29(4):587-601. doi: 10.1016/j.ccell.2016.03.005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels Halama, MD principal investigator
National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Heidelberg, Germany
Dirk Jaeger, MD study director
National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Neoplasm Metastasis, run by National Center for Tumor Diseases, Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01736813, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2017.