Liver CancerPhase 2NCT00717756
Lenalidomide for Advanced Hepatocellular Cancer:A Phase II Trial
A Phase 2 study testing lenalidomide in people with Liver Cancer, run by Brown University at 3 sites in United States.
Trial summary
This study will determine whether lenalidomide has activity in patients with advanced liver cancer that have had growth of their cancer after sorafenib. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2009to Jan 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed HCC or triple phase CT consistent with HCC in a patient with known cirrhosis and AFP > 200 ng/ml.
- Disease not amenable to curative surgical resection
- Patients must have been previously treated with sorafenib. Patients who are unable to receive sorafenib due to financial reasons are also eligible.
- All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study.
- No previous thalidomide.
- Patients must have radiologically assessable tumor.
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- ECOG performance status of 0-2 at study entry.
- Understand and voluntarily sign an informed consent form.
- Age >18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Laboratory test results within these ranges:
- Absolute neutrophil count > 1000/mm3
- Platelet count > 60,000/mm3
- Serum creatinine > 2.0 mg/dL
- Total bilirubin > 4 mg/dL
- AST (SGOT) and ALT (SGPT) > 5 x ULN.
- Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. See Appendix: H Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods, AND also Appendix: F Education and Counseling Guidance Document
- Disease free of prior malignancies for > 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast
Who cannot join
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Known hypersensitivity to thalidomide.
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
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- Any prior use of lenalidomide.
- Concurrent use of other anti-cancer agents or treatments.
- Known positive for HIV. (The effect of immune modulation of lenalidomide on patients who are HIV positive is unknown).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Memorial Hospital of Rhode island
Pawtucket, Rhode Island, 02860
Lifespan Hospitals
Providence, Rhode Island, 02903
Montefiore Medical Center
The Bronx, New York, 10467
About this study
This study will determine whether lenalidomide has activity in patients with advanced liver cancer that have had growth of their cancer after sorafenib.
Read the detailed description
This study will determine the response rate and toxicities of lenalidomide as second line treatment for patients with liver cancer who have progressed after sorafenib.
- Conditions
- Liver Cancer
- Being tested
- lenalidomide
- Keywords
- liver cancer, second line
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lenalidomideDrug
Also called revlimid
25 mg po qd x 21 days then 1 week off equals one cycle
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide | Experimental | Not described Receives: Drug: lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate by Recist Criteria
radiographic response defined as partial response defined by RECIST:At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD
It is noted that while on average the time frame for scans was 4 months, there were two patients who at 32 and 36 months had not progressed.
Measured: on average about every 2 months until progression, on average about 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Hospital of Rhode Island, Roger Williams Medical Center
- Responsible party
- Principal investigator, howard safran, Brown University
- Investigators
- Howard Safran, MD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717756
- Sponsor's protocol ID
- BrUOG-HC-212
- Other IDs
- Celgene # RV-HCC-PI- 0159, celgene
- Status last verified
- Feb 2020
- First submitted
- 15 Jul 2008
- Last updated
- 17 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Safran H, Charpentier KP, Kaubisch A, Mantripragada K, Dubel G, Perez K, Faricy-Anderson K, Miner T, Eng Y, Victor J, Plette A, Espat J, Bakalarski P, Wingate P, Berz D, Luppe D, Martel D, Rosati K, Aparo S. Lenalidomide for second-line treatment of advanced hepatocellular cancer: a Brown University oncology group phase II study. Am J Clin Oncol. 2015 Feb;38(1):1-4. doi: 10.1097/COC.0b013e3182868c66.
PubMed 23648434
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lenalidomide for Advanced Hepatocellular Cancer:A Phase II Trial
- ClinicalTrials.gov ID
- NCT00717756
- Acronym / sponsor ID
- BrUOG-HC-212
- Conditions
- Liver Cancer
- Keywords
- liver cancer, second line
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Memorial Hospital of Rhode Island, Roger Williams Medical Center
- Study start
- Jan 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 17 Jul 2008 (estimated)
- Results
- Posted 3 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine whether lenalidomide has activity in patients with advanced liver cancer that have had growth of their cancer after sorafenib.
Detailed description
This study will determine the response rate and toxicities of lenalidomide as second line treatment for patients with liver cancer who have progressed after sorafenib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide | Experimental | Drug: lenalidomide |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Pathologically confirmed HCC or triple phase CT consistent with HCC in a patient with known cirrhosis and AFP > 200 ng/ml.
- Disease not amenable to curative surgical resection
- Patients must have been previously treated with sorafenib. Patients who are unable to receive sorafenib due to financial reasons are also eligible.
- All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study.
- No previous thalidomide.
Key exclusion criteria (9 listed)
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Known hypersensitivity to 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 |
|---|---|---|
| lenalidomideAlso: revlimid25 mg po qd x 21 days then 1 week off equals one cycle | Drug | Lenalidomide |
Primary outcome
Response Rate by Recist Criteria
Time frame: on average about every 2 months until progression, on average about 4 months.
radiographic response defined as partial response defined by RECIST:At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD It is noted that while on average the time frame for scans was 4 months, there were two patients who at 32 and 36 months had not progressed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23648434Safran H, Charpentier KP, Kaubisch A, Mantripragada K, Dubel G, Perez K, Faricy-Anderson K, Miner T, Eng Y, Victor J, Plette A, Espat J, Bakalarski P, Wingate P, Berz D, Luppe D, Martel D, Rosati K, Aparo S. Lenalidomide for second-line treatment of advanced hepatocellular cancer: a Brown University oncology group phase II study. Am J Clin Oncol. 2015 Feb;38(1):1-4. doi: 10.1097/COC.0b013e3182868c66.
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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.
Howard Safran, MD principal investigator
Brown University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lenalidomide in people with Liver Cancer, run by Brown University at 3 sites in United States.
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 18 inclusion and 9 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 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 3 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Response Rate by Recist Criteria (time frame: on average about every 2 months until progression, on average about 4 months.). 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 NCT00717756, 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 17 Feb 2020.