Solid TumorsPhase 1/2TEXONCT01166035
Lenalidomide and Cetuximab in Patients With Advanced Solid Tumors
A Phase 1/2 study testing Lenalidomide and Cetuximab in people with Solid Tumors, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
This is a Phase 1/2, open-label, monocentric, dose-escalation study of lenalidomide in combination with cetuximab in subjects with solid tumors. The primary objective is to establish the maximum tolerated dose (MTD) of lenalidomide in combination with cetuximab in patients with solid tumors including colorectal cancer… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Lenalidomide and Cetuximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2010to Dec 2011
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Disease Characteristics:
- Patients signed informed consent.
- Histologically or cytologically confirmed SCCHN, NSCLC, or metastatic colorectal adenocarcinoma.
- At least one unidimensionally measurable lesion.
- 18 - 80 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of <= 1.
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- Female subjects of childbearing potential must:
- Understand that the study medication could have an expected teratogenic risk
- Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhoea. An alternative would be an absolute and continued sexual abstinence.
- The following are effective methods of contraception
- Implant
- Levonorgestrel-releasing intrauterine system (IUS)**
- Medroxyprogesterone acetate depot
- Tubal sterilisation
- Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses Ovulation inhibitory progesterone-only pills (i.e., desogestrel)
- Combined oral contraceptive pills are not recommended. If a subject was using combined oral contraception, she must switch to one of the methods above. The increased risk of VTE continues for 4 to 6 weeks after stopping combined oral contraception.
- Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml not more than 3 days before the start of study medication once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence.
- Agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment, except in the case of confirmed tubal sterilization. These tests should be performed not more than 3 days before the start
- of next treatment. This requirement also applies to women of childbearing potential who practice complete and continued abstinence
- Male subjects must
- Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study therapy if their partner is of childbearing potential and has no contraception.
- Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
- All subjects must
- Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
- Agree not to share study medication with another person and to return all unused study drug to the investigator
Who cannot join
- Prior Treatment:
- Use of chemotherapy, hormonal therapy, immunotherapy, or any other anticancer or experimental therapy within 28 days prior to study medication.
- Active participation in another clinical trial.
- Radiotherapy within 28 days prior to study medication.
- Surgery within 28 days prior to study medication (minimally invasive procedures for the purpose of diagnosis or staging of the disease are permitted).
- Prior therapy with pomalidomide (CC-4047), lenalidomide, or thalidomide.
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- Laboratory:
- Absolute neutrophil count (ANC) < 1.5 x 109/L.
- Platelet count < 100 x 109/L.
- Creatinine Clearance < 50 mL/min.
- Bilirubin > 1.5 x Upper Limit Normal (ULN) (> 2.0 x ULN in the presence of Gilbert's Syndrome).
- Serum aspartate transaminase (AST)/SGOT > 3.0 x ULN (> 5 x ULN in the presence of liver metastases).
- Other Disease State:
- Untreated, symptomatic brain metastases (brain imaging not required).
- Venous thromboembolism within 6 months.
- Current congestive heart failure (New York Heart Association class II-IV).
- Uncontrolled hypertension
- Prior malignancies within 5 years, with the exception of treated basal cell/squamous cell carcinoma of the skin or "in-situ" carcinoma of the cervix or breast.
- General:
- Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study or confound the ability to interpret data from the study.
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or lactating females.
Trial locations and contacts
1 site in 1 country.
Heinz Zwierzina, Prof. Dr. contact
Notfallaufnahme TILAK contact
Austria1 site, 1 recruiting
- Recruiting
Medical University of Innsbruck, Department for Internal Medicine I
Innsbruck, Tyrol, 6020
Heinz Zwierzina, Prof. Dr., +43 (0)512 -504-81427, heinz.zwierzina@i-med.ac.at
Wolfgang Hilbe, M.D.
About this study
Official title: Phase 1/2 Study of Lenalidomide and Cetuximab in Patients With Advanced Solid Tumors
This is a Phase 1/2, open-label, monocentric, dose-escalation study of lenalidomide in combination with cetuximab in subjects with solid tumors. The primary objective is to establish the maximum tolerated dose (MTD) of lenalidomide in combination with cetuximab in patients with solid tumors including colorectal cancer (CRC), squamous cell carcinoma of the head and neck (SCCHN) and non-small cell lung cancer (NSCLC).
Read the detailed description
Background: For metastatic cancer such as head and neck, lung and colorectal cancer, standard therapy comprises chemotherapy regimen partially in combination with monoclonal antibodies blocking the vascular endothelial growth factor (VEGF) or the epidermal growth factor receptor (EGFR). When disease progression occurs during or after these treatment options have been applied, no established therapy is available and the clinical development of new strategies is warranted. Lenalidomide (Revlimid®) is a thalidomide derivative and belongs to the so-called ImiDs, a class of immunostimulatory molecules. IMiDs have profound effects on the immune system. Obviously, IMiDs are able to function as co-stimulatory molecule for mature T cells. In addition, IMiDs are able to mitigate the negative effects of CTLA-4 signalling. On the molecular level, IMiDs induce phosphorylation of CD28, underlining the concept that they act as costimulatory signals during T cell activation. Furthermore, the induction of specific CTL responses by dendritic cells (DC) is enhanced and the activity of suppressive regulatory T cells (Treg) inhibited.
In addition to their effects on cells of the adaptive immune system, IMiDs also target the innate immune response. Natural killer cells (NK) as well as natural killer T-cells (NKT) are activated by Immunomodulatory Drugs (IMiDs), and the effects of IMiDs on NK and NKT cells might further contribute to the immune-activating properties of ImiDs.
Therefore the rationale of the combination of lenalidomide with a therapeutic IgG1 antibody such as cetuximab (Erbitux®) is based on the fact that several reports suggest a role of antibody-dependent cellular cytotoxicity (ADCC) as a mode of action of cetuximab.
However, the exact definition of these anti-cancer mechanisms of lenalidomide alone and in combination with cetuximab in vivo require further investigation in early clinical trials.
The goal of this phase I/II trial is to define the toxicity of the combination of lenalidomide and cetuximab and to study potential effects on the tumor and the immune system.
Subjects meeting all inclusion criteria will be enrolled in cohorts of three patients to receive a single, oral dose of lenalidomide administered on Days 1-28 and intravenous (IV) infusions of cetuximab (400 mg/m2 first infusion only, then 250 mg/m2 subsequently) administered on Days 1, 8, 15, and 22 of each 28-day cycle.
Prior to combination therapy, there will be a 21 day lead in treatment period with lenalidomide monotherapy (Days -21 to -1). Combination treatment will start at Day 1. Tumor biopsies will be taken before monotherapy lenalidomide treatment (between d-25 and -22) and between Day -3 and -1 (before starting cetuximab). A third tumor biopsy will be taken between Cycle 1 Day 21 and 28 after starting combination therapy. Cycles will be repeated every 28 days. All subjects will continue on study drug until disease progression, unacceptable toxicity or treatment discontinuation for any other reason. The MTD of lenalidomide will be defined as the highest dose level at which no more than 1 out of 6 subjects experience a dose-limiting toxicity (DLT) during the first cycle of administration in combination with cetuximab. Safety measurements and analysis will be performed at each visit.
- Conditions
- Solid Tumors
- Being tested
- Lenalidomide, Cetuximab
- Keywords
- Solid tumors, Lenalidomide, Cetuximab, Colorectal Cancer, Non-Small Cell Lung Cancer, Head and Neck Cancer
- Medical subject headings
- Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Lenalidomide will be supplied as 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration.
Prior to Cycle 1, there will be a 21 day lead in treatment period with lenalidomide monotherapy (Days -21 to -1). Combination treatment will start at Day 1. Subjects will be enrolled in cohorts of three to receive a single, oral dose of lenalidomide administered on Days 1-28. For each cohort of subjects, the decision of whether or not to dose-escalate will be made after subjects have received the first treatment cycle of study drug. Treatment will continue until the occurrence of any of the following events.
- Disease progression
- Adverse event(s) that, in the judgment of the Investigator, may cause severe or permanent harm or which rule out continuation of the treatment regimen.
- Major violation of the study protocol.
- Withdrawal of consent
- Lost to follow up
- Death
- Suspected pregnancy
CetuximabDrug
Combination treatment will start at Day 1. Subjects meeting will be enrolled in cohorts of three to receive infusions of cetuximab (400 mg/m2 first infusion only, then 250 mg/m2 subsequently) administered on Days 1, 8, 15, and 22 of each 28-day cycle. Cetuximab will be supplied as Erbitux® 22 mg/ml Vial à 50 ml, Erbitux 5 mg/ml Vial à 10 ml and Erbitux 5 mg/ml Vial à 50 ml for intravenous administration.
Treatment will continue until the occurrence of any of the following events.
- Disease progression
- Adverse event(s) that, in the judgment of the Investigator, may cause severe or permanent harm or which rule out continuation of the treatment regimen.
- Major violation of the study protocol.
- Withdrawal of consent
- Lost to follow up
- Death
- Suspected pregnancy
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Determination of the maximum tolerated dose (MTD) of lenalidomide administered in combination with cetuximab. For each cohort of subjects (3 patients), the decision of whether or not to dose-escalate will be made after subjects have received the first treatment cycle of study drug. Once 2 subjects have experienced DLT, enrollment at that dose will end and that dose will be declared to have exceeded the MTD.
Measured: on the end of every treatment cycle (28 day-cycles).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2011 (estimated)
- Study completionDec 2011 (estimated)
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 Solid TumorsStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation, Innsbruck - Tyrolean Working Group of Experimental Oncology (TEXO)
- Investigators
- Heinz Zwierzina, Prof. Dr., Principal investigator, Medical University of Innsbruck, Deparmtment of Internal Medicince I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166035
- Sponsor's protocol ID
- TEXO0309
- Acronym
- TEXO
- Status last verified
- May 2010
- First submitted
- 19 Jul 2010
- Last updated
- 20 Jul 2010
- Results posted
- No
Publications
Gamerith G, Auer T, Amann A, Putzer D, Schenk B, Kircher B, Hilbe W, Zwierzina H, Loeffler-Ragg J. Increase in antibody-dependent cellular cytotoxicity (ADCC) in a patient with advanced colorectal carcinoma carrying a KRAS mutation under lenalidomide therapy. Cancer Biol Ther. 2014 Mar 1;15(3):266-70. doi: 10.4161/cbt.27327. Epub 2013 Dec 18.
PubMed 24351336
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Study of Lenalidomide and Cetuximab in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01166035
- Acronym / sponsor ID
- TEXO / TEXO0309
- Conditions
- Solid Tumors
- Keywords
- Solid tumors, Lenalidomide, Cetuximab, Colorectal Cancer, Non-Small Cell Lung Cancer, Head and Neck Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Collaborators
- Celgene Corporation, Innsbruck - Tyrolean Working Group of Experimental Oncology (TEXO)
- Study start
- Mar 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 20 Jul 2010 (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.
This is a Phase 1/2, open-label, monocentric, dose-escalation study of lenalidomide in combination with cetuximab in subjects with solid tumors. The primary objective is to establish the maximum tolerated dose (MTD) of lenalidomide in combination with cetuximab in patients with solid tumors including colorectal cancer (CRC), squamous cell carcinoma of the head and neck (SCCHN) and non-small cell lung cancer (NSCLC).
Detailed description
Background: For metastatic cancer such as head and neck, lung and colorectal cancer, standard therapy comprises chemotherapy regimen partially in combination with monoclonal antibodies blocking the vascular endothelial growth factor (VEGF) or the epidermal growth factor receptor (EGFR). When disease progression occurs during or after these treatment options have been applied, no established therapy is available and the clinical development of new strategies is warranted. Lenalidomide (Revlimid®) is a thalidomide derivative and belongs to the so-called ImiDs, a class of immunostimulatory molecules. IMiDs have profound effects on the immune system. Obviously, IMiDs are able to function as co-stimulatory molecule for mature T cells. In addition, IMiDs are able to mitigate the negative effects of CTLA-4 signalling. On the molecular level, IMiDs induce phosphorylation of CD28, underlining the concept that they act as costimulatory signals during T cell activation. Furthermore, the induction of specific CTL responses by dendritic cells (DC) is enhanced and the activity of suppressive regulatory T cells (Treg) inhibited.
In addition to their effects on cells of the adaptive immune system, IMiDs also target the innate immune response. Natural killer cells (NK) as well as natural killer T-cells (NKT) are activated by Immunomodulatory Drugs (IMiDs), and the effects of IMiDs on NK and NKT cells might further contribute to the immune-activating properties of ImiDs.
Therefore the rationale of the combination of lenalidomide with a therapeutic IgG1 antibody such as cetuximab (Erbitux®) is based on the fact that several reports suggest a role of antibody-dependent cellular cytotoxicity (ADCC) as a mode of action of cetuximab.
However, the exact definition of these anti-cancer mechanisms of lenalidomide alone and in combination with cetuximab in vivo require further investigation in early clinical trials.
The goal of this phase I/II trial is to define the toxicity of the combination of lenalidomide and cetuximab and to study potential effects on the tumor and the immune system.
Subjects meeting all inclusion criteria will be enrolled in cohorts of three patients to receive a single, oral dose of lenalidomide administered on Days 1-28 and intravenous (IV) infusions of cetuximab (400 mg/m2 first infusion only, then 250 mg/m2 subsequently) administered on Days 1, 8, 15, and 22 of each 28-day cycle.
Prior to combination therapy, there will be a 21 day lead in treatment period with lenalidomide monotherapy (Days -21 to -1). Combination treatment will start at Day 1. Tumor biopsies will be taken before monotherapy lenalidomide treatment (between d-25 and -22) and between Day -3 and -1 (before starting cetuximab). A third tumor biopsy will be taken between Cycle 1 Day 21 and 28 after starting combination therapy. Cycles will be repeated every 28 days. All subjects will continue on study drug until disease progression, unacceptable toxicity or treatment discontinuation for any other reason. The MTD of lenalidomide will be defined as the highest dose level at which no more than 1 out of 6 subjects experience a dose-limiting toxicity (DLT) during the first cycle of administration in combination with cetuximab. Safety measurements and analysis will be performed at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Patients signed informed consent.
- Histologically or cytologically confirmed SCCHN, NSCLC, or metastatic colorectal adenocarcinoma.
- At least one unidimensionally measurable lesion.
- 18 - 80 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of <= 1.
Key exclusion criteria (22 listed)
- Use of chemotherapy, hormonal therapy, immunotherapy, or any other anticancer or experimental therapy within 28 days prior to study medication.
- Active participation in another clinical trial.
- Radiotherapy within 28 days prior to study medication.
- Surgery within 28 days prior to study medication (minimally invasive procedures for the purpose of diagnosis or staging of the disease are permitted).
- Prior therapy with pomalidomide (CC-4047), lenalidomide, or thalidomide.
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 |
|---|---|---|
| LenalidomideLenalidomide will be supplied as 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Prior to Cycle 1, there will be a 21 day lead in treatment period with lenalidomide monotherapy (Days -21 to -1). Combination treatment will start at Day 1. Subjects will be enrolled in cohorts of three to receive a single, oral dose of lenalidomide administered on Days 1-28. For each cohort of subjects, the decision of whether or not to dose-escalate will be made after subjects have received the first treatment cycle of study drug. Treatment will continue until the occurrence of any of the following events. * Disease progression * Adverse event(s) that, in the judgment of the Investigator, may cause severe or permanent harm or which rule out continuation of the treatment regimen. * Major violation of the study protocol. * Withdrawal of consent * Lost to follow up * Death * Suspected pregnancy | Drug | – |
| CetuximabCombination treatment will start at Day 1. Subjects meeting will be enrolled in cohorts of three to receive infusions of cetuximab (400 mg/m2 first infusion only, then 250 mg/m2 subsequently) administered on Days 1, 8, 15, and 22 of each 28-day cycle. Cetuximab will be supplied as Erbitux® 22 mg/ml Vial à 50 ml, Erbitux 5 mg/ml Vial à 10 ml and Erbitux 5 mg/ml Vial à 50 ml for intravenous administration. Treatment will continue until the occurrence of any of the following events. * Disease progression * Adverse event(s) that, in the judgment of the Investigator, may cause severe or permanent harm or which rule out continuation of the treatment regimen. * Major violation of the study protocol. * Withdrawal of consent * Lost to follow up * Death * Suspected pregnancy | Drug | – |
Primary outcome
Maximum tolerated dose
Time frame: on the end of every treatment cycle (28 day-cycles).
Determination of the maximum tolerated dose (MTD) of lenalidomide administered in combination with cetuximab. For each cohort of subjects (3 patients), the decision of whether or not to dose-escalate will be made after subjects have received the first treatment cycle of study drug. Once 2 subjects have experienced DLT, enrollment at that dose will end and that dose will be declared to have exceeded the MTD.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2010.
- Derived from this study: PubMed 24351336Gamerith G, Auer T, Amann A, Putzer D, Schenk B, Kircher B, Hilbe W, Zwierzina H, Loeffler-Ragg J. Increase in antibody-dependent cellular cytotoxicity (ADCC) in a patient with advanced colorectal carcinoma carrying a KRAS mutation under lenalidomide therapy. Cancer Biol Ther. 2014 Mar 1;15(3):266-70. doi: 10.4161/cbt.27327. Epub 2013 Dec 18.
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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.
Heinz Zwierzina, Prof. Dr. contact
Notfallaufnahme TILAK contact
Heinz Zwierzina, Prof. Dr. principal investigator
Medical University of Innsbruck, Deparmtment of Internal Medicince I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lenalidomide and Cetuximab in people with Solid Tumors, run by Medical University Innsbruck at 1 site in Austria.
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 25 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 20 Jul 2010. 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 Austria. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heinz Zwierzina, Prof. Dr. (0512 504 81427), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (time frame: on the end of every treatment cycle (28 day-cycles).). 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 NCT01166035, 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 20 Jul 2010.