GlioblastomaPhase 2NCT00165477
Study of Lenalidomide and XRT in Patients With Newly Diagnosed Glioblastoma Multiforme
A Phase 2 study testing lenalidomide and Radiation in people with Glioblastoma and Gliosarcoma, run by Dana-Farber Cancer Institute at 4 sites in United States.
Trial summary
The purpose of this study is to find out if the combination of lenalidomide and radiation therapy is effective in controlling tumor growth in patients with newly-diagnosed supratentorial glioblastoma or gliosarcoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Gliosarcoma, Malignant Gliomas
- What is being tested?
- lenalidomide and Radiation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 23 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2005to Jul 2009
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed newly-diagnosed supratentorial glioblastoma multiforme (GBM) or gliosarcoma will be eligible for this protocol.
- The patient must have recovered from the effects of surgery, post-operative infections and other complications before entry into the study.
- Diagnosis will have been established by biopsy or resection no more than 28 days prior to registration.
- If tumor resection or open biopsy was performed, cranial MRI or contrast CT must have been performed before and after surgery. Imaging within 96 h of surgery is preferred but not required.
- If needle biopsy (stereotactic) was performed, gadolinium MRI or contrast CT within 14 days prior to registration is required. A post-operative scan is not required. The use of MRI rather than CT is preferred. The same type of scan, i.e., MRI or CT must be used throughout the period of protocol treatment for tumor measurement. Patients without measurable or assessable disease are eligible.
- Patients receiving steroids must be on stable or decreasing doses for at least 5 days prior to entry.
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- Patients must have a plan to begin partial brain radiotherapy 4-7 days after beginning lenalidomide, and within 35 days of the surgical procedure that established the diagnosis.
- Radiotherapy must be at the Radiation Oncology Department of the registered institution.
- Patients must be willing to forego cytotoxic and non-cytotoxic drug therapy against the tumor while being treated with lenalidomide.
- All patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
- Patients must be > 18 years old, and with a life expectancy > 8 weeks.
- Patients must have a Karnofsky performance status of > 60.
- Patients must have adequate bone marrow, liver, and renal function.
- Patients must be willing and able to comply with all study requirements
Who cannot join
- Patient must not have had prior cranial radiation therapy.
- Patients must not have received prior cytotoxic drug therapy, non-cytotoxic drug therapy, or experimental drug therapy for brain tumors. Patients who received Gliadel wafers will be excluded.
- Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patients ability to tolerate this therapy.
- Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible.
- Patients must not have active infection.
- Patients must not be pregnant/breast feeding and must agree to practice adequate contraception.
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- Patients must not have any disease that will obscure toxicity or dangerously alter drug metabolism.
- Patients must not have serious concurrent medical illness.
- Patient with recent thromboembolic disease (deep vein thrombosis and pulmonary embolism) are eligible if they are clinically stable and the thromboembolic event occurred more than 2 weeks prior to enrollment into this protocol.
- Patients must not have metastases below the tentorium or beyond the cranial vault.
- Patients must not have a known diagnosis of HIV, active infectious hepatitis, or chronic hepatitis.
- Patients must have no history of hypersensitivity or development of a desquamating rash while on thalidomide.
- Patients must have no prior exposure to lenalidomide.
- Previous or planned stereotactic radiosurgery or brachytherapy.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
University of Virginia
Charlottesville, Virginia, 22908-0394
About this study
Official title: Phase II Study of Lenalidomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme.
- The purpose of this study is to find out if the combination of lenalidomide and radiation therapy is effective in controlling tumor growth in patients with newly-diagnosed supratentorial glioblastoma or gliosarcoma.
Read the detailed description
- Patients will receive lenalidomide orally once daily for 21 days followed by a one week rest period (this is equivalent to one cycle).
- Four to seven days from the first dose of lenalidomide, the patient will start radiation therapy for approximately 6-7 weeks.
- A neurologic exam and routine blood tests will be performed weekly while the patient is receiving radiation therapy.
- Following the 11th week of treatment a MRI/CT scan will be performed to assess the status of the tumor. If there is no change, or there is shrinkage in the size of the tumor, the treatment will continue for another 4 week cycle.
- The four week cycle will continue as long as the disease remains stable or improved and the patient does not develop intolerable side effects. A MRI/CT scan will be done every 2 cycles (8 weeks).
- Conditions
- Glioblastoma, Gliosarcoma, Malignant Gliomas
- Being tested
- lenalidomide, Radiation
- Keywords
- Glioblastoma, Gliosarcoma, Malignant Gliomas, Radiation Therapy, IMiD, Lenalidomide
- Medical subject headings
- Glioblastoma, Gliosarcoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lenalidomideDrug
Also called Revlimid
Given orally once a day for 21 days followed by a 1 week rest period. Subject may continue to receive study drug as long as the disease does not worsen and they experience serious side effects
RadiationRadiation
Also called XRT
Starting 4-7 days after the start of lenalidomide and given once a day, 5 days a week for 6-7 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the efficacy of lenalidomide with conventional radiation therapy in the treatment of patients with newly-diagnosed supratentorial glioblastoma or gliosarcoma.
Measured: 3 years
Secondary outcomes (4)
To assess the proportion of patients treated with lenalidomide and radiation therapy surviving at 12 months
Measured: 3 years
to evaluate the time to tumor progression
Measured: 3 years
the radiologic response
Measured: 3 years
to determine the safety and toxicity of the combination of lenalidomide and radiation therapy.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionNov 2007
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Massachusetts General Hospital, University of Virginia
- Investigators
- Patrick Y. Wen, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165477
- Sponsor's protocol ID
- 05-222
- Status last verified
- Mar 2010
- First submitted
- 9 Sep 2005
- Last updated
- 10 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Lenalidomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme.
- ClinicalTrials.gov ID
- NCT00165477
- Acronym / sponsor ID
- 05-222
- Conditions
- Glioblastoma, Gliosarcoma, Malignant Gliomas
- Keywords
- Glioblastoma, Gliosarcoma, Malignant Gliomas, Radiation Therapy, IMiD, Lenalidomide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Celgene Corporation, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Massachusetts General Hospital, University of Virginia
- Study start
- Sep 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 14 Sep 2005 (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 purpose of this study is to find out if the combination of lenalidomide and radiation therapy is effective in controlling tumor growth in patients with newly-diagnosed supratentorial glioblastoma or gliosarcoma.
Detailed description
- Patients will receive lenalidomide orally once daily for 21 days followed by a one week rest period (this is equivalent to one cycle).
- Four to seven days from the first dose of lenalidomide, the patient will start radiation therapy for approximately 6-7 weeks.
- A neurologic exam and routine blood tests will be performed weekly while the patient is receiving radiation therapy.
- Following the 11th week of treatment a MRI/CT scan will be performed to assess the status of the tumor. If there is no change, or there is shrinkage in the size of the tumor, the treatment will continue for another 4 week cycle.
- The four week cycle will continue as long as the disease remains stable or improved and the patient does not develop intolerable side effects. A MRI/CT scan will be done every 2 cycles (8 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients with histologically confirmed newly-diagnosed supratentorial glioblastoma multiforme (GBM) or gliosarcoma will be eligible for this protocol.
- The patient must have recovered from the effects of surgery, post-operative infections and other complications before entry into the study.
- Diagnosis will have been established by biopsy or resection no more than 28 days prior to registration.
- If tumor resection or open biopsy was performed, cranial MRI or contrast CT must have been performed before and after surgery. Imaging within 96 h of surgery is preferred but not required.
- If needle biopsy (stereotactic) was performed, gadolinium MRI or contrast CT within 14 days prior to registration is required. A post-operative scan is not required. The use of MRI rather than CT is preferred. The same type of scan, i.e., MRI or CT must be used throughout the period of protocol treatment for tumor measurement. Patients without measurable or assessable disease are eligible.
Key exclusion criteria (14 listed)
- Patient must not have had prior cranial radiation therapy.
- Patients must not have received prior cytotoxic drug therapy, non-cytotoxic drug therapy, or experimental drug therapy for brain tumors. Patients who received Gliadel wafers will be excluded.
- Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patients ability to tolerate this therapy.
- Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible.
- Patients must not have active infection.
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: RevlimidGiven orally once a day for 21 days followed by a 1 week rest period. Subject may continue to receive study drug as long as the disease does not worsen and they experience serious side effects | Drug | – |
| RadiationAlso: XRTStarting 4-7 days after the start of lenalidomide and given once a day, 5 days a week for 6-7 weeks | Radiation | – |
Primary outcome
To determine the efficacy of lenalidomide with conventional radiation therapy in the treatment of patients with newly-diagnosed supratentorial glioblastoma or gliosarcoma.
Time frame: 3 years
4 secondary outcomes
To assess the proportion of patients treated with lenalidomide and radiation therapy surviving at 12 months
Time frame: 3 years
to evaluate the time to tumor progression
Time frame: 3 years
the radiologic response
Time frame: 3 years
to determine the safety and toxicity of the combination of lenalidomide and radiation therapy.
Time frame: 3 years
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 10 Mar 2010.
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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.
Patrick Y. Wen, MD principal investigator
Dana-Farber Cancer Institute
4 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 and Radiation in people with Glioblastoma and Gliosarcoma, run by Dana-Farber Cancer Institute at 4 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 14 inclusion and 14 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 10 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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?
To determine the efficacy of lenalidomide with conventional radiation therapy in the treatment of patients with newly-diagnosed supratentorial glioblastoma or gliosarcoma. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2010.