GlioblastomaEarly Phase 1NCT00864864
Sunitinib Tumor Levels in Patients Not on Enzyme-Inducing Anti-Epileptic Drugs Undergoing Debulking Surgery for Recurrent Glioblastoma
A Early Phase 1 study testing Sunitinib in people with Glioblastoma and Brain Tumor, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The purpose of this research study is to determine if sunitinib can get past the blood-brain barrier and into the brain tumor. Sunitinib has shown promising results in treating other cancers and works by blocking blood flow to tumors, which may prevent them from growing further. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Brain Tumor
- What is being tested?
- Sunitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2007to May 2013
- Phase
- Early Phase 1
- 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
- Histologically confirmed glioblastoma
- 18 years of age or older
- Karnofsky Performance Status 60 or greater
- Patient must be on no anti-epileptic drugs (AED) or AED that are non-enzyme inducing (NEIAED)
- There is no limit to the number of prior chemotherapy regimens
- No concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast. Patients with prior malignancies must be disease-free for 5 years or more
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- Mini-mental status examination score of 15 or less
- Resolution of all acute toxic effect of prior chemotherapy, radiotherapy, or surgical procedures to grade 1 or less
- Adequate organ function as outlined in the protocol
Who cannot join
- Major surgery within 4 weeks of starting the study treatment
- Radiation therapy within 3 months of starting the study treatment
- Chemotherapy within 4 weeks (within 6 weeks for nitrosoureas) prior to entering the study
- Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials are allowed
- Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure. stroke or transient ischemic attack, or pulmonary embolism
- Ongoing cardiac dysrhythmias of NCI CTCAE grade 2 or greater
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- Prolonged QTc interval on baseline EKG
- Hypertension that cannot be controlled by medications
- Patients must not have a known coagulopathy that increases risk of bleeding or a history of clinically significant hemorrhages in the past
- Patients must be on therapeutic doses of anti-coagulants or anti-platelet agents while taking sunitinib
- Grade 3 systemic hemorrhage within 4 weeks fo starting the study treatment
- Patients whose MRI scan shows clinically significant intratumoral or peritumoral hemorrhage
- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or active infection
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study
- Concomitant use of ketoconazole and other agents known to induce CYP3A4
- Pregnancy or breastfeeding
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Pilot Study of Sunitinib Tumor Levels in Patients Not on Enzyme-Inducing Anti-Epileptic Drugs Undergoing Debulking Surgery for Recurrent Glioblastoma
The purpose of this research study is to determine if sunitinib can get past the blood-brain barrier and into the brain tumor. Sunitinib has shown promising results in treating other cancers and works by blocking blood flow to tumors, which may prevent them from growing further. At the present time, there is no chemotherapy that can cure glioblastoma. The reason why chemotherapy is not fully effective is that many drugs cannot penetrate into brain tumors. This is due to the presence of the blood-brain barrier (BBB) which normally protects the brain from substances in the blood.
Read the detailed description
- Participants will take the study drug, sunitinib, for 7 days prior to their surgery. The surgery is part of the routine care for glioblastoma and will be performed on Day 8. The study drug is supplied in capsule form and is to be taken at home.
- On Day 7 participants will come to the clinic and have the following tests and procedures performed: Neurological and physical examination; vital signs; and blood samples. On day 9 (the day after the surgery) an MRI scan will be performed.
- Fourteen days after the participants surgery (Day 22), they will restart sunitinib treatment. They will take the study drug once a day for 4 weeks followed by a 2 week rest period (no study drug treatment). This 6 week period is called a cycle of study treatment. Participants can continue to receive cycles of study treatment as long as their disease does not progress and they do not experience any serious side-effects.
- Before each new cycle of study treatment (once every 6 weeks) the participant will come into the clinic for the following tests: Neurological and physical examination; vital signs; blood sample; urine sample; MRI scan of the brain (done every even cycle).
- Conditions
- Glioblastoma, Brain Tumor
- Being tested
- Sunitinib
- Keywords
- sunitinib
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunitinibDrug
Taken orally on days 1-7 prior to surgery and then starting again on Day 22 for 4 weeks followed by a 2 week rest period
| Study group | Role | What they receive |
|---|---|---|
| Sunitinib | Experimental | Not described Receives: Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the ability of sunitinib to achieve a target tumor: plasma ration greater than or equal to 0.2 in patients with recurrent GM.
Measured: 3 years
Secondary outcomes (1)
To determine if there is an association between growth factor receptor inhibition and tumor phenotype, tumor: plasma ratio of sunitinib and overall survival.
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 posted19 Mar 2009 (estimated)
- Study startMay 2007
- Primary completionMay 2011
- Study completionMay 2013
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 Massachusetts General HospitalThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Dana-Farber Cancer Institute, Pfizer
- Responsible party
- Principal investigator, Scott Randall Plotkin, MD, PhD, Massachusetts General Hospital
- Investigators
- Scott Plotkin, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864864
- Sponsor's protocol ID
- 06-307
- Status last verified
- Jul 2016
- First submitted
- 17 Mar 2009
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Sunitinib Tumor Levels in Patients Not on Enzyme-Inducing Anti-Epileptic Drugs Undergoing Debulking Surgery for Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT00864864
- Acronym / sponsor ID
- 06-307
- Conditions
- Glioblastoma, Brain Tumor
- Keywords
- sunitinib
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Dana-Farber Cancer Institute, Pfizer
- Study start
- May 2007
- Primary completion
- May 2011 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 19 Mar 2009 (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 research study is to determine if sunitinib can get past the blood-brain barrier and into the brain tumor. Sunitinib has shown promising results in treating other cancers and works by blocking blood flow to tumors, which may prevent them from growing further. At the present time, there is no chemotherapy that can cure glioblastoma. The reason why chemotherapy is not fully effective is that many drugs cannot penetrate into brain tumors. This is due to the presence of the blood-brain barrier (BBB) which normally protects the brain from substances in the blood.
Detailed description
- Participants will take the study drug, sunitinib, for 7 days prior to their surgery. The surgery is part of the routine care for glioblastoma and will be performed on Day 8. The study drug is supplied in capsule form and is to be taken at home.
- On Day 7 participants will come to the clinic and have the following tests and procedures performed: Neurological and physical examination; vital signs; and blood samples. On day 9 (the day after the surgery) an MRI scan will be performed.
- Fourteen days after the participants surgery (Day 22), they will restart sunitinib treatment. They will take the study drug once a day for 4 weeks followed by a 2 week rest period (no study drug treatment). This 6 week period is called a cycle of study treatment. Participants can continue to receive cycles of study treatment as long as their disease does not progress and they do not experience any serious side-effects.
- Before each new cycle of study treatment (once every 6 weeks) the participant will come into the clinic for the following tests: Neurological and physical examination; vital signs; blood sample; urine sample; MRI scan of the brain (done every even cycle).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sunitinib | Experimental | Drug: Sunitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed glioblastoma
- 18 years of age or older
- Karnofsky Performance Status 60 or greater
- Patient must be on no anti-epileptic drugs (AED) or AED that are non-enzyme inducing (NEIAED)
- There is no limit to the number of prior chemotherapy regimens
Key exclusion criteria (18 listed)
- Major surgery within 4 weeks of starting the study treatment
- Radiation therapy within 3 months of starting the study treatment
- Chemotherapy within 4 weeks (within 6 weeks for nitrosoureas) prior to entering the study
- Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials are allowed
- Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure. stroke or transient ischemic attack, or pulmonary embolism
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 |
|---|---|---|
| SunitinibTaken orally on days 1-7 prior to surgery and then starting again on Day 22 for 4 weeks followed by a 2 week rest period | Drug | Sunitinib |
Primary outcome
To assess the ability of sunitinib to achieve a target tumor: plasma ration greater than or equal to 0.2 in patients with recurrent GM.
Time frame: 3 years
1 secondary outcome
To determine if there is an association between growth factor receptor inhibition and tumor phenotype, tumor: plasma ratio of sunitinib and overall survival.
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 7 Jul 2016.
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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.
Scott Plotkin, MD, PhD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sunitinib in people with Glioblastoma and Brain Tumor, run by Massachusetts General Hospital at 2 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 9 inclusion and 18 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 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 assess the ability of sunitinib to achieve a target tumor: plasma ration greater than or equal to 0.2 in patients with recurrent GM. (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 7 Jul 2016.